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Alsoubani M, Chow J. Navigating Coronavirus Disease 2019 in Immunocompromised Populations: Evolving Risk Factors, Treatment, and Outcomes. Infect Dis Clin North Am 2025; 39:309-329. [PMID: 40055107 DOI: 10.1016/j.idc.2025.02.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/10/2025]
Abstract
The coronavirus disease 2019 (COVID-19) pandemic has disproportionately impacted immunocompromised hosts, leading to higher morbidity and mortality. The clinical outcomes have varied based on the degree of immunosuppression, treatment availability, severe acute respiratory syndrome coronavirus 2 variants, and vaccination status. This review discusses the evolving epidemiology, clinical presentation, treatment, and prevention strategies for COVID-19 in immunocompromised populations, including patients living with human immunodeficiency virus, solid organ transplant, and hematopoietic stem cell transplant recipients.
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Affiliation(s)
- Majd Alsoubani
- Division of Geographic Medicine and Infectious Diseases, Department of Medicine, Tufts Medical Center, Boston, MA, USA; The Stuart B. Levy Center for the Integrated Management of Antimicrobial Resistance, Tufts University School of Medicine, Boston, MA, USA.
| | - Jennifer Chow
- Division of Geographic Medicine and Infectious Diseases, Department of Medicine, Tufts Medical Center, Boston, MA, USA. https://twitter.com/JennKChow
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Adamuz J, González-Samartino M, Jiménez-Martínez E, Tapia-Pérez M, López-Jiménez MM, Valero-Valdelvira P, Zuriguel-Pérez E, Berbis-Morelló C, Asensio-Flores S, Juvé-Udina ME. Impact of nurse staffing coverage and care complexity factors on health outcomes in hospitalized COVID-19 patients: a cross-sectional study. BMC Nurs 2025; 24:520. [PMID: 40361094 PMCID: PMC12076968 DOI: 10.1186/s12912-025-03142-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/07/2024] [Accepted: 04/29/2025] [Indexed: 05/15/2025] Open
Abstract
BACKGROUND Few studies have captured the impact of inadequate nurse staffing levels and broader health patient conditions in admitted patients during the COVID-19 pandemic. We aimed to determine the association between nurse staffing coverage, care complexity individual factors (CCIFs) and adverse events (AEs) in patients admitted with COVID-19. METHODS A multicentre cross-sectional study was conducted from March 1, 2020 to March 31, 2022 at eight public health hospitals in Spain. All patients with COVID-19 who were admitted to these hospitals were included. The main variables included AEs, nurse staffing coverage (as measured using the ATIC patient classification system) and CCIFs to evaluate broader patient health conditions. Adjusted logistic models were performed to identify associations with AEs, stratified by patients admitted to wards and hospitalized patients who required admission to intensive care units (ICUs). RESULTS A total of 11,968 hospitalized patients, 2,824 (23.6%) experienced AEs. Multivariate analysis showed that higher levels of nurse staffing coverage protected against AEs. Among patients admitted to acute wards, the independent risk factors for AEs included old age, haemodynamic instability, chronic disease, uncontrolled pain, urinary or faecal incontinence and mental status impairments. In addition to these factors, extreme weight, position impairment and communication disorders were factors associated with AEs in patients who required ICU admission. CONCLUSIONS Nurse staffing coverage was a protective factor for AEs. Several CCIFs related to comorbidity/complications, developmental, and mental-cognitive domains were strongly associated with AEs. Therefore, ensuring safe nurse staffing levels could be improve patient outcomes.
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Affiliation(s)
- Jordi Adamuz
- Nursing Knowledge Management and Information Systems Department, Hospital Universitari de Bellvitge - IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat (Barcelona), 08907, Spain.
- Faculty of Nursing, University of Barcelona, L'Hospitalet de Llobregat, Spain.
- IDIBELL, Bellvitge Institute of Biomedical Research, Barcelona, Spain.
| | - Maribel González-Samartino
- Nursing Knowledge Management and Information Systems Department, Hospital Universitari de Bellvitge - IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat (Barcelona), 08907, Spain
- Faculty of Nursing, University of Barcelona, L'Hospitalet de Llobregat, Spain
- Nursing Management Team, Bellvitge University Hospital, L'Hospitalet de Llobregat, Spain
- IDIBELL, Bellvitge Institute of Biomedical Research, Barcelona, Spain
| | - Emilio Jiménez-Martínez
- Faculty of Nursing, University of Barcelona, L'Hospitalet de Llobregat, Spain
- Infectious Disease Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Spain
- IDIBELL, Bellvitge Institute of Biomedical Research, Barcelona, Spain
| | - Marta Tapia-Pérez
- Nursing Knowledge Management and Information Systems Department, Hospital Universitari de Bellvitge - IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat (Barcelona), 08907, Spain
- IDIBELL, Bellvitge Institute of Biomedical Research, Barcelona, Spain
| | - María-Magdalena López-Jiménez
- Nursing Knowledge Management and Information Systems Department, Hospital Universitari de Bellvitge - IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat (Barcelona), 08907, Spain
- Faculty of Nursing, University of Barcelona, L'Hospitalet de Llobregat, Spain
- IDIBELL, Bellvitge Institute of Biomedical Research, Barcelona, Spain
| | - Patricia Valero-Valdelvira
- Research Group on Innovation, Health Economics, and Digital Transformation (INEDIT), Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain
| | - Esperanza Zuriguel-Pérez
- Nurse Research Coordinator, VHIR, Vall d'Hebron Institute of Biomedical Research, Barcelona, Spain
| | | | - Susana Asensio-Flores
- Nursing Management Team, Bellvitge University Hospital, L'Hospitalet de Llobregat, Spain
- IDIBELL, Bellvitge Institute of Biomedical Research, Barcelona, Spain
| | - Maria-Eulàlia Juvé-Udina
- IDIBELL, Bellvitge Institute of Biomedical Research, Barcelona, Spain
- Catalan Institute of Health, Barcelona, Spain
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Andersen KM, Brouillette MA, Togo K, Tanabe K, Carter BT, Kent MT, Ding Y, Curcio D, Welch V, McGrath LJ, Ilyas B, Ito S. Inpatient Burden of COVID-19 in Japan: A Retrospective Cohort Study. J Infect Chemother 2025:102721. [PMID: 40306488 DOI: 10.1016/j.jiac.2025.102721] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/08/2024] [Revised: 04/01/2025] [Accepted: 04/22/2025] [Indexed: 05/02/2025]
Abstract
BACKGROUND Changing disease dynamics and access to COVID-19 vaccines in Japan warrant a timely description of the burden of severe disease. Here we report inpatient healthcare resource utilization of COVID-19 in Japan and contextualize results with influenza. METHODS We selected persons hospitalized for COVID-19 (ICD-10 code U07.1) from April 1, 2020 - January 31, 2024 or influenza (ICD-10 code J09.X - J11.x) from November 1, 2017 - October 31, 2019 from Medical Data Vision, a large hospital-based database in Japan. Outcomes of interest were length of stay, intensive care unit (ICU) admission, receipt of invasive mechanical ventilation (IMV), and inpatient mortality, assessed overall, as well as stratified by age groups and calendar time. FINDINGS Among 5,684 hospitalized COVID-19 cases, persons were older (median age 80 vs 64) and had a longer length of stay (median 21 vs 5 days) than the 18,584 influenza cases. The proportions of patients admitted to ICU (3% vs 1%), received IMV (6% vs 3%) and died in hospital (12% vs 3%) were higher in COVID-19 patients than influenza patients. Burden was higher in adult COVID-19 patients than pediatric COVID-19 patients, although for both adults and pediatric patients, COVID-19 burden surpassed influenza. Inpatient burden of COVID-19 between May 2023 and January 2024 remained greater than influenza, with 5-times longer length of stay, more frequent need for ICU care (3-times higher), IMV support (2-times higher) and in-hospital deaths (4-times higher). INTERPRETATION These findings underscore the need for continued prevention and treatment of COVID-19 to prevent severe disease.
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Affiliation(s)
- Kathleen M Andersen
- Pfizer Inc., 66 Hudson Boulevard East, New York, New York, United States, 10001.
| | | | - Kanae Togo
- Pfizer Japan Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo, Japan, 151-8589
| | - Kosuke Tanabe
- Pfizer Japan Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo, Japan, 151-8589
| | - Benjamin T Carter
- Genesis Research, 111 River Street Suite 1120, Hoboken, New Jersey, United States, 07030
| | - Matthew T Kent
- Genesis Research, 111 River Street Suite 1120, Hoboken, New Jersey, United States, 07030
| | - Yingjie Ding
- Genesis Research, 111 River Street Suite 1120, Hoboken, New Jersey, United States, 07030
| | - Daniel Curcio
- Pfizer Inc., 66 Hudson Boulevard East, New York, New York, United States, 10001
| | - Verna Welch
- Pfizer Inc., 66 Hudson Boulevard East, New York, New York, United States, 10001
| | - Leah J McGrath
- Pfizer Inc., 66 Hudson Boulevard East, New York, New York, United States, 10001
| | - Bushra Ilyas
- Pfizer Inc., 66 Hudson Boulevard East, New York, New York, United States, 10001
| | - Shuhei Ito
- Pfizer Japan Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo, Japan, 151-8589
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Vaidya L, Rizvi N, Wu XC, Maniscalco LS, Yi Y, Ochoa A, Yu Q. Differences in Covid-19 deaths amongst cancer patients and possible mediators for this relationship. Sci Rep 2025; 15:10407. [PMID: 40140499 PMCID: PMC11947243 DOI: 10.1038/s41598-025-95037-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/18/2024] [Accepted: 03/18/2025] [Indexed: 03/28/2025] Open
Abstract
Previous research demonstrated Non-Hispanic Black populations experience higher COVID-19 mortality rates than Non-Hispanic White individuals. Additionally, cancer status is a known risk factor for COVID-19 death. While prior studies investigated comorbidities as exploratory variables in differences in COVID-19 hospitalization, none have explored their role in COVID-19-related deaths. This study aimed to evaluate whether Charlson Comorbidity Index (CCI) and subsequently, individual diseases are potential explanatory variables for this relationship. The analysis focused on Non-Hispanic Black and Non-Hispanic White cancer patients aged 20 or older, diagnosed between 2011 and 2019, who tested positive for COVID-19 from the start of pandemic through June 30, 2021 from Louisiana Tumor Registry. Two separate mediation analyses were conducted. First checked whether overall comorbidity, measured by CCI, could explain the difference in COVID-19 mortality. If so, further checked which individual comorbidities contributed to this difference. The hazard rate for Non-Hispanic Black cancer patients dying from COVID-19 was 6.46 times than that of Non-Hispanic White patients. The CCI accounted for 12.7% of the differences observed in COVID-19 mortality, with renal disease as the top contributor, explaining 4.9%. These findings could help develop interventions to reduce COVID-19 mortality and address the disproportionate impact, especially by managing chronic conditions like renal disease.
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Affiliation(s)
- Leah Vaidya
- Biostatistics and Data Science, School of Public Health, Louisiana State University Health Sciences Center, New Orleans, LA, USA
| | - Nubaira Rizvi
- Biostatistics and Data Science, School of Public Health, Louisiana State University Health Sciences Center, New Orleans, LA, USA
| | - Xiao-Cheng Wu
- Louisiana Tumor Registry, School of Public Health, Louisiana State University Health Sciences Center, New Orleans, LA, USA
| | - Lauren S Maniscalco
- Louisiana Tumor Registry, School of Public Health, Louisiana State University Health Sciences Center, New Orleans, LA, USA
| | - Yong Yi
- Louisiana Tumor Registry, School of Public Health, Louisiana State University Health Sciences Center, New Orleans, LA, USA
| | - Augusto Ochoa
- Stanley S. Scott Cancer Center, School of Medicine, Louisiana State University Health Sciences Center, New Orleans, LA, USA
| | - Qingzhao Yu
- Biostatistics and Data Science, School of Public Health, Louisiana State University Health Sciences Center, New Orleans, LA, USA.
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Lai CH, Chen CH, Chiu YW, Huang FW, Wu SY, Shih HM, Hsueh PR. Efficacy of monocyte distribution width in predicting critical illness in patients with COVID-19 pneumonia: a retrospective cohort study. BMC Infect Dis 2025; 25:400. [PMID: 40128650 PMCID: PMC11934797 DOI: 10.1186/s12879-024-10391-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/04/2024] [Accepted: 12/23/2024] [Indexed: 03/26/2025] Open
Abstract
BACKGROUND Identifying patients at a risk of severe COVID-19 is crucial for prompt intervention and mortality risk mitigation. The monocyte distribution width (MDW) is an effective accurate predictor of sepsis in emergency settings, facilitating timely patient management. However, few reliable laboratory parameters are available for predicting the severity and prognosis of COVID-19. Thus, this study was conducted to investigate whether MDW can accurately predict the severity and progression of COVID-19 pneumonia. METHODS This retrospective cohort study included patients with COVID-19 pneumonia who had been admitted to our hospital between January 1, 2022, and September 31, 2022. The primary outcome was the development of critical illness, which was assessed in terms of intensive care unit (ICU) admission, need for mechanical ventilation (MV), or mortality. The secondary outcomes were durations of ICU stay, MV, and hospital stay. Multivariate logistic regression was performed to estimate the risks of critical illness and mortality. RESULTS Data from 878 patients with COVID-19 were analyzed. Of these, 258 (29.4%) developed critical illness. The high-MDW group (MDW > 22) showed a higher rate of critical illness (155/452, 34.29%) compared to the low-MDW group (103/426, 24.18%). Mortality was also higher in the high-MDW group (95/452, 21.02%) than in the low-MDW group (37/426, 8.69%). Patients with MDW > 22 exhibited a significantly higher risk of developing critical illness (adjusted odds ratio [aOR]: 1.48; 95% confidence interval [CI]: 1.08-2.04) and mortality (aOR: 2.46; 95% CI: 1.63-3.74) compared to those with MDW ≤ 22. CONCLUSION Our findings suggest that an elevated MDW value at presentation may serve as a promising predictor of severe outcomes in patients with COVID-19 pneumonia. This underscores the need for further research to validate the utility of MDW in predicting critical illness among patients with viral pneumonia.
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Affiliation(s)
- Chia-Hung Lai
- School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan
| | - Chun-Hung Chen
- School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan
- Department of Emergency Medicine, China Medical University Hospital, Taichung, Taiwan
| | - Yen-Wei Chiu
- School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan
- Department of Emergency Medicine, China Medical University Hospital, Taichung, Taiwan
| | - Fen-Wei Huang
- Department of Emergency Medicine, China Medical University Hospital, Taichung, Taiwan
| | - Shih-Yun Wu
- School of Medicine, Chang Gung University, Taoyuan, Taiwan
| | - Hong-Mo Shih
- School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan.
- Department of Emergency Medicine, China Medical University Hospital, Taichung, Taiwan.
| | - Po-Ren Hsueh
- Department of Laboratory Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan
- Division of Infectious Diseases, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan
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Gwin ME, Wahid U, Bhalla S, Kandathil A, Malone S, Natchimuthu V, Watkins C, Vice L, Chatriand H, Moten H, Tan C, Styrvoky KC, Johnson DH, Semlow AR, Lee JL, Browning T, Mullins MA, Santini NO, Oliver G, Zhang S, Gerber DE. Virtual Health Care Encounters for Lung Cancer Screening in a Safety-Net Population: Observations From the COVID-19 Pandemic. JCO Clin Cancer Inform 2025; 9:e2400086. [PMID: 40053882 DOI: 10.1200/cci.24.00086] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/12/2024] [Revised: 08/14/2024] [Accepted: 01/14/2025] [Indexed: 03/09/2025] Open
Abstract
PURPOSE The COVID-19 pandemic disrupted normal mechanisms of health care delivery and facilitated the rapid and widespread implementation of telehealth technology. As a result, the effectiveness of virtual health care visits in diverse populations represents an important consideration. We used lung cancer screening as a prototype to determine whether subsequent adherence differs between virtual and in-person encounters in an urban, safety-net health care system. METHODS We conducted a retrospective analysis of initial low-dose computed tomography (LDCT) ordered for lung cancer screening from March 2020 through February 2023 within Parkland Health, the integrated safety-net provider for Dallas County, TX. We collected data on patient characteristics, visit type, and LDCT completion from the electronic medical record. Associations among these variables were assessed using the chi-square test. We also performed interaction analyses according to visit type. RESULTS Initial LDCT orders were placed for a total of 1,887 patients, of whom 43% were female, 45% were Black, and 17% were Hispanic. Among these orders, 343 (18%) were placed during virtual health care visits. From March to August 2020, 79 of 163 (48%) LDCT orders were placed during virtual visits; after that time, 264 of 1,724 (15%) LDCT orders were placed during virtual visits. No patient characteristics were significantly associated with visit type (in-person v virtual) or LDCT completion. Rates of LDCT completion were 95% after in-person visits and 97% after virtual visits (P = .13). CONCLUSION In a safety-net lung cancer screening population, patients were as likely to complete postvisit initial LDCT when ordered in a virtual encounter as in an in-person encounter.
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Affiliation(s)
- Mary E Gwin
- Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX
| | - Urooj Wahid
- O'Donnell School of Public Health, UT Southwestern Medical Center, Dallas, TX
| | - Sheena Bhalla
- Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX
- Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX
| | - Asha Kandathil
- Department of Radiology, UT Southwestern Medical Center, Dallas, TX
| | - Sarah Malone
- O'Donnell School of Public Health, UT Southwestern Medical Center, Dallas, TX
| | | | | | | | | | | | | | - Kim C Styrvoky
- Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX
| | - David H Johnson
- Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX
- Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX
| | | | - Jessica L Lee
- O'Donnell School of Public Health, UT Southwestern Medical Center, Dallas, TX
| | - Travis Browning
- Department of Radiology, UT Southwestern Medical Center, Dallas, TX
| | - Megan A Mullins
- O'Donnell School of Public Health, UT Southwestern Medical Center, Dallas, TX
- Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX
| | | | | | - Song Zhang
- O'Donnell School of Public Health, UT Southwestern Medical Center, Dallas, TX
| | - David E Gerber
- Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX
- O'Donnell School of Public Health, UT Southwestern Medical Center, Dallas, TX
- Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX
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Nilsson NH, Bendix M, Öhlund L, Gibbs A, Widerström M, Werneke U, Maripuu M. Lithium and the risk of severe COVID-19 infection: A retrospective population-based register study. J Psychosom Res 2025; 190:112053. [PMID: 39965301 DOI: 10.1016/j.jpsychores.2025.112053] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/08/2024] [Revised: 01/19/2025] [Accepted: 02/06/2025] [Indexed: 02/20/2025]
Abstract
OBJECTIVES Previous research has suggested antiviral properties for lithium, including potential effectiveness against COVID-19 in vitro. This study aimed to investigate the impact of lithium and other psychotropic drugs on the risks of mortality, hospitalization, and ICU admission due to COVID-19 among individuals with bipolar disorder. The primary objective was to assess whether lithium was beneficial in COVID-19-infection in a real-world population. METHODS Retrospective register study using data from multiple Swedish patient registers, including 39,063 individuals in Sweden with bipolar disorder and prescribed mood stabilizers. Outcomes included COVID-19-associated death, hospitalization, and ICU admission between 11 March 2020 and 10 March 2021. Multivariate logistic regression adjusted for age, sex, and somatic comorbidities was conducted. RESULTS Lithium were prescribed to 44.2 % of patients, either as mono- or combination therapy; other mood stabilizers were prescribed to 55.8 %. There were no significant associations between lithium and COVID-19-associated death, hospitalization, or ICU admission. Atypical antipsychotics were associated with increased odds ratios for COVID-19-associated death (OR 1.58 [95 % CI 1.01-2.47]), hospitalization (OR 1.80 [95 % CI 1.49-2.18]), and ICU admission (OR 2.25 [95 % CI 1.33-3.80]). Benzodiazepines were associated with a significant increase in COVID-19-associated death (OR 1.54 [95 % CI 1.01-2.35]) and hospitalization OR 1.26 [95 % CI 1.03-1.53]). In an ad hoc analysis, lithium monotherapy was, however, associated with reduced hospitalizations and ICU admissions. CONCLUSIONS Our findings weaken the hypothesis that lithium reduces the risk of severe events associated with COVID-19 infection in bipolar disorder.
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Affiliation(s)
- Niklas Harry Nilsson
- Department of Clinical Sciences, Division of Psychiatry, Umeå University, Umeå, Sweden.
| | - Marie Bendix
- Department of Clinical Sciences, Division of Psychiatry, Umeå University, Umeå, Sweden; Department of Clinical Neuroscience, Center for Psychiatry Research & Stockholm Health Care Services, Stockholm County Council, Karolinska Institutet, Stockholm, Sweden.
| | - Louise Öhlund
- Department of Clinical Sciences, Division of Psychiatry, Sunderby Research Unit, Umeå University, Umeå, Sweden.
| | - Anna Gibbs
- Department of Clinical Sciences, Division of Psychiatry, Sunderby Research Unit, Umeå University, Umeå, Sweden.
| | | | - Ursula Werneke
- Department of Clinical Sciences, Division of Psychiatry, Sunderby Research Unit, Umeå University, Umeå, Sweden.
| | - Martin Maripuu
- Department of Clinical Sciences, Division of Psychiatry, Umeå University, Umeå, Sweden.
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Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Ansari W, Harrington MA, Simón-Campos A, Chew KW, Pypstra R, Rusnak JM. Alleviation of COVID-19 Symptoms and Reduction in Healthcare Utilization Among High-risk Patients Treated With Nirmatrelvir/Ritonavir (NMV/R): A Phase 3 Randomized Trial. Clin Infect Dis 2025; 80:323-330. [PMID: 39523543 PMCID: PMC11848284 DOI: 10.1093/cid/ciae551] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2024] [Revised: 10/21/2024] [Accepted: 11/07/2024] [Indexed: 11/16/2024] Open
Abstract
BACKGROUND Nirmatrelvir/ritonavir (NMV/r) is an oral antiviral treatment for mild to moderate coronavirus disease 2019 (COVID-19). METHODS This phase 2/3, double-blind, randomized (1:1) study assessed oral NMV/r 300 mg/100 mg versus placebo every 12 hours for 5 days in high-risk, unvaccinated, nonhospitalized, symptomatic adults with COVID-19 from 343 sites across 21 countries. In testing the primary endpoint of COVID-19‒related hospitalization and all-cause deaths and key secondary endpoints, including symptom duration and COVID-19‒related medical visits, type I error was controlled with prespecified sequential testing and the Hochberg procedure. RESULTS Among 2113 randomized patients enrolled from July 2021 through December 2021, 1966 (NMV/r, n = 977; placebo, n = 989) were included in the prespecified analysis population (symptom onset ≤5 days, did not receive monoclonal antibodies). NMV/r significantly reduced times to sustained alleviation (median, 13 vs 15 days; hazard ratio = 1.27, P < .0001) and resolution (16 vs 19 days; hazard ratio = 1.20, P = .0022) through day 28 and significantly reduced the number of COVID-19‒related medical visits and the proportion of patients with such visits. Hospitalized patients treated with NMV/r had shorter stays, none required intensive care unit admission or mechanical ventilation, and all were discharged to home/self-care. Fewer NMV/r-treated patients required additional treatment for COVID-19. No NMV/r-treated patients died through week 24 compared with 15 placebo-treated patients. CONCLUSIONS In addition to reducing COVID-19‒related hospitalization or death from any cause through day 28, NMV/r was found to also reduce duration of COVID-19 symptoms and utilization of healthcare resources versus placebo in patients at high risk of progressing to severe disease. CLINICAL TRIAL INFORMATION ClinicalTrials.gov, NCT04960202, https://clinicaltrials.gov/study/NCT04960202.
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Affiliation(s)
- Jennifer Hammond
- Pfizer Research and Development, Pfizer, Collegeville, Pennsylvania, USA
| | | | - Annie Gardner
- Pfizer Research and Development, Pfizer, Cambridge, Massachusetts, USA
| | - Paula Abreu
- Pfizer Research and Development, Pfizer, New York, New York, USA
| | - Weihang Bao
- Pfizer Research and Development, Pfizer, New York, New York, USA
| | - Wayne Wisemandle
- Pfizer Research and Development, Pfizer, Lake Forest, Illinois, USA
| | | | | | | | - Kara W Chew
- Infectious Diseases, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California, USA
| | - Rienk Pypstra
- Pfizer Research and Development, Pfizer, New York, New York, USA
| | - James M Rusnak
- Pfizer Research and Development, Pfizer, Tampa, Florida, USA
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Ali S, Azarian T. An ecological study of COVID-19 outcomes among Florida counties. BMC Public Health 2025; 25:579. [PMID: 39939852 PMCID: PMC11817068 DOI: 10.1186/s12889-025-21764-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2024] [Accepted: 02/04/2025] [Indexed: 02/14/2025] Open
Abstract
BACKGROUND During the COVID-19 pandemic, Florida reported some of the highest numbers of cases and deaths in the US; however, county-level variation in COVID-19 outcomes has yet to be comprehensively investigated. The present ecological study aimed to assess correlates of COVID-19 outcomes among Florida counties that explain variation in case rate, mortality rate, and case fatality rate (CFR) across pandemic waves. METHOD We obtained county-level administrative data and COVID-19 case reports from public repositories. We tested spatial autocorrelation to assess geographic clustering in COVID-19 case rate, mortality rate, and CFR. Stepwise linear regression was employed to investigate the association between COVID-19 outcomes and 17 demographic, socioeconomic, and health-related county-level predictors. RESULTS We found mortality rate and CFR were significantly higher in rural counties compared to urban counties, among which significant differences in vaccination coverage were also observed. Multivariate analysis found that the percentage of the population aged over 65 years, the percentage of obese people, and the percentage of the rural population were significant predictors of COVID-19 case rate. Median age, vaccination coverage, percentage of people who smoke, and percentage of the population with diabetes were significant influencing factors for CFR. Importantly, higher vaccination coverage was significantly associated with a reduction in case rate (R = -0.26, p = 0.03) and mortality (R = -0.51, p < 0.001). Last, we found that spatial dependencies play a role in explaining variations in COVID-19 CFR among Florida counties. CONCLUSION Our findings emphasize the need for targeted, equitable public health strategies to reduce disparities and enhance population resilience during public health crises.
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Affiliation(s)
- Sobur Ali
- Burnett School of Biomedical Sciences, University of Central Florida, Orlando, FL, USA
| | - Taj Azarian
- Burnett School of Biomedical Sciences, University of Central Florida, Orlando, FL, USA.
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Sezak N, Karaca B, Balik R, Aksun M. Prognostic Value of Neutrophil/Lymphocyte, Lymphocyte/C-reactive protein, Platelet/ Lymphocyte Rates in Covid-19 Cases Monitored in the Intensive Care Unit. Angiology 2025:33197251318094. [PMID: 39927475 DOI: 10.1177/00033197251318094] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/11/2025]
Abstract
Coronavirus 2019 (COVID-19) infection has a significant mortality rate. Despite the disease's extensive effects, little is known about the prognostic indicators that can be used. We aimed to assess the prognostic value of neutrophil-to-lymphocyte ratio (NLR), lymphocyte-to-C-reactive protein ratio (LCR) and platelet-to- lymphocyte ratio (PLR) in predicting mortality of intensive care unit (ICU) patients. Demographic data, underlying diseases, laboratory parameters were evaluated. The study included 222 cases. The mortality rate was 57.65%. No significant differences in terms of sex, age, or underlying disease were observed between the two groups with and without mortality. Obesity, oxygen therapy, invasive mechanical ventilation (IMV) rates and high SOFA (Sequential Organ Failure Assessment) scores were found to be significantly higher in the group with a mortal course. The mortality rate was significantly higher in patients with lung involvement over 50%, with a low lymphocyte count at ICU admission. In this patient group, NLR was found to be higher, and LCR was found to be lower (P = .001). Although there was no significant difference in PLR between the two groups in univariate analysis, multivariate analysis revealed that PLR was independently associated with mortality. High NLR and low LCR values at ICU admission might serve as early warning signs for healthcare providers, allowing them to identify patients at higher risk of mortality.
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Affiliation(s)
- Nurbanu Sezak
- Department of Infectious Disease and Clinical Microbiology, Izmir Democracy University Faculty of Medicine, Izmir, Turkiye
| | - Banu Karaca
- Department of Infectious Disease and Clinical Microbiology, Izmir Katip Celebi University Faculty of Medicine, Izmir, Turkiye
| | - Recep Balik
- Department of Infectious Disease and Clinical Microbiology, Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, Turkiye
| | - Murat Aksun
- Department of Anesthesiology and Reanimation, Izmir Katip Celebi University Faculty of Medicine, Izmir, Turkiye
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11
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Lambo J, Keli S, Kaplan SK, Njideaka-Kevin T, Arja SB, Khedir Omer Altahir A, Olonade I, Kumar R. The descriptive epidemiology of adverse events following two doses of mRNA COVID-19 vaccination in Curaçao, the Caribbean. Infect Dis (Lond) 2025; 57:137-149. [PMID: 39226235 DOI: 10.1080/23744235.2024.2399108] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/28/2024] [Revised: 07/15/2024] [Accepted: 08/28/2024] [Indexed: 09/05/2024] Open
Abstract
BACKGROUND BNT162b2 and mRNA-1273 COVID-19 vaccines have been used for mass vaccinations in Curaçao, the Caribbean but information on adverse events (AEs)in this population is unavailable. This study describes the characteristics of vaccinees that incurred AEs, explores the associations between AEs by vaccine and doses, and estimates the rate of AEs. METHODS Vaccination and AEs data for all persons of age 5 years (range 5-105 years) and older who received two doses of COVID-19 vaccine at 71 centres in Curaçao between February 24, 2021, and April 5, 2023, were included in this retrospective observational study. RESULTS The vaccines differed significantly in the frequency distribution of vaccinees by age, age groups, sex, AEs, and prior COVID-19 infection. Occurrence of AEs was strongly associated with mRNA vaccine brand, sex, number of doses, but not with age, age group, and prior COVID-19 infection. Of 209,720 doses, 84 persons (0.04%) incurred AEs following two doses of mRNA vaccines (overall rate of 40.1 per 100,000 persons (95% CI 32.4-49.6). AEs were also significantly higher in females compared to males.AE rates associated with BNT162b2, and mRNA-1273 vaccines were low, but BNT162b2 vaccinees incurred substantially significantly higher AE rates (58.3 per 100,000 persons, 95% CI 45.4-74.9) than mRNA-1273 vaccinees (21.9 per 100,000 persons, 95% CI 14.6-32.8). mRNA-1273 vaccine was associated with a significantly lower risk of AEs. CONCLUSIONS AE reporting varied by age, sex, and vaccine used as well as the number of doses. Future studies with follow-up and longer-term reporting of AEs should be conducted.
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Affiliation(s)
- Jonathan Lambo
- Department of Epidemiology and Evidence-based Medicine, Avalon University School of Medicine, Willemstad, Curaçao
| | - Sirving Keli
- Department of Epidemiology and Evidence-based Medicine, Avalon University School of Medicine, Willemstad, Curaçao
| | - Shaheen Khan Kaplan
- Department of Epidemiology and Evidence-based Medicine, Avalon University School of Medicine, Willemstad, Curaçao
| | - Temiloluwa Njideaka-Kevin
- Department of Epidemiology and Evidence-based Medicine, Avalon University School of Medicine, Willemstad, Curaçao
| | - Sireesha Bala Arja
- Department of Epidemiology and Evidence-based Medicine, Avalon University School of Medicine, Willemstad, Curaçao
| | - Alaa Khedir Omer Altahir
- Department of Epidemiology and Evidence-based Medicine, Avalon University School of Medicine, Willemstad, Curaçao
| | - Itunu Olonade
- Department of Epidemiology and Evidence-based Medicine, Avalon University School of Medicine, Willemstad, Curaçao
| | - Rohit Kumar
- Department of Epidemiology and Evidence-based Medicine, Avalon University School of Medicine, Willemstad, Curaçao
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12
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Fakih MG, Daragjati F, Sturm LK, Miller C, McKenzie B, Randall K, Masoudi FA, Moxham J, Ghosh S, Raja JK, Bollinger A, Garrett-Ray S, Chadwick M, Aloia T, Fogel R. Optimizing and Sustaining Clinical Outcomes in 88 US Hospitals Post-Pandemic: A Quality Improvement Initiative. Jt Comm J Qual Patient Saf 2025; 51:86-94. [PMID: 39710561 DOI: 10.1016/j.jcjq.2024.11.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/04/2024] [Revised: 11/18/2024] [Accepted: 11/19/2024] [Indexed: 12/24/2024]
Abstract
BACKGROUND Optimizing outcomes of hospitalized patients anchors on standardizing processes in medical management, interventions to reduce the risk of decompensation, and prompt intervention when a patient decompensates. METHODS A quality improvement initiative (optimized sepsis and respiratory compromise management, reducing health care-associated infection and medication risk, swift management of the deteriorating patient, feedback on performance, and accountability) was implemented in a multistate health system. The primary outcome was risk-adjusted in-hospital mortality. Secondary outcomes included health care-associated infections, patient-days with hypoglycemic and severe hyperglycemic episodes, and hospital onset (HO) acute kidney injury (AKI). RESULTS A total of 2,015,408 patients were admitted to 88 hospitals over the 36-month study period. Overall mortality improved from the baseline observed/expected (O/E) of 0.97 in 2021 to 0.74 in 2023 (-23.4%; 4,186 fewer deaths, p < 0.001). Controlling for baseline (2021) mortality O/E ratios, the mean mortality O/E ratio for 2023 was 0.74 for system and 0.84 for peers, representing a difference of -0.10 (p < 0.001, 95% confidence interval [CI] 0.12 - -0.07], with 1,807 fewer deaths). The standardized infection ratio declined for central line-associated blood stream infections by 24.8% (0.58; 88 fewer events), catheter-associated urinary tract infections by 30.6% (0.44; 98 fewer events), HO methicillin-resistant Staphylococcus aureus bacteremia by 29.0% (0.72; 67 fewer events), and HO Clostridioides difficile infection by 35.1% (0.36; 311 fewer events) in 2023 compared to 2021. HO AKI episodes dropped by 6.2% (8.6%; 1,725 fewer events), and patient-days with hypoglycemia and severe hyperglycemia decreased by 5.8% (4.0%; 4,840 fewer events) and 22.8% (5.2%; 30,065 fewer events), respectively. CONCLUSION This systemwide initiative focusing on standardizing processes, feedback on performance, and accountability was associated with sustainable improvements in mortality and a reduction in infectious and safety events.
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13
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Maison DP, Tasissa H, Deitchman A, Peluso MJ, Deng Y, Miller FD, Henrich TJ, Gerschenson M. COVID-19 clinical presentation, management, and epidemiology: a concise compendium. Front Public Health 2025; 13:1498445. [PMID: 39957982 PMCID: PMC11826932 DOI: 10.3389/fpubh.2025.1498445] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2024] [Accepted: 01/21/2025] [Indexed: 02/18/2025] Open
Abstract
Coronavirus Disease 2019, caused by severe acute respiratory coronavirus 2, has been an ever-evolving disease and pandemic, profoundly impacting clinical care, drug treatments, and understanding. In response to this global health crisis, there has been an unprecedented increase in research exploring new and repurposed drugs and advancing available clinical interventions and treatments. Given the widespread interest in this topic, this review aims to provide a current summary-for interested professionals not specializing in COVID-19-of the clinical characteristics, recommended treatments, vaccines, prevention strategies, and epidemiology of COVID-19. The review also offers a historical perspective on the pandemic to enhance understanding.
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Affiliation(s)
- David P. Maison
- Department of Cell and Molecular Biology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI, United States
- Division of Experimental Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, United States
| | - Hawi Tasissa
- Department of Clinical Pharmacy, University of California, San Francisco, San Francisco, CA, United States
| | - Amelia Deitchman
- Department of Clinical Pharmacy, University of California, San Francisco, San Francisco, CA, United States
| | - Michael J. Peluso
- Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, CA, United States
| | - Youping Deng
- Department of Quantitative Health Sciences, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI, United States
| | - F. DeWolfe Miller
- Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI, United States
| | - Timothy J. Henrich
- Division of Experimental Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, United States
| | - Mariana Gerschenson
- Department of Cell and Molecular Biology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI, United States
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14
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Rowley EA, Mitchell PK, Yang DH, Lewis N, Dixon BE, Vazquez-Benitez G, Fadel WF, Essien IJ, Naleway AL, Stenehjem E, Ong TC, Gaglani M, Natarajan K, Embi P, Wiegand RE, Link-Gelles R, Tenforde MW, Fireman B. Methods to Adjust for Confounding in Test-Negative Design COVID-19 Effectiveness Studies: Simulation Study. JMIR Form Res 2025; 9:e58981. [PMID: 39869907 PMCID: PMC11811671 DOI: 10.2196/58981] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/08/2024] [Revised: 10/22/2024] [Accepted: 11/10/2024] [Indexed: 01/29/2025] Open
Abstract
BACKGROUND Real-world COVID-19 vaccine effectiveness (VE) studies are investigating exposures of increasing complexity accounting for time since vaccination. These studies require methods that adjust for the confounding that arises when morbidities and demographics are associated with vaccination and the risk of outcome events. Methods based on propensity scores (PS) are well-suited to this when the exposure is dichotomous, but present challenges when the exposure is multinomial. OBJECTIVE This simulation study aimed to investigate alternative methods to adjust for confounding in VE studies that have a test-negative design. METHODS Adjustment for a disease risk score (DRS) is compared with multivariable logistic regression. Both stratification on the DRS and direct covariate adjustment of the DRS are examined. Multivariable logistic regression with all the covariates and with a limited subset of key covariates is considered. The performance of VE estimators is evaluated across a multinomial vaccination exposure in simulated datasets. RESULTS Bias in VE estimates from multivariable models ranged from -5.3% to 6.1% across 4 levels of vaccination. Standard errors of VE estimates were unbiased, and 95% coverage probabilities were attained in most scenarios. The lowest coverage in the multivariable scenarios was 93.7% (95% CI 92.2%-95.2%) and occurred in the multivariable model with key covariates, while the highest coverage in the multivariable scenarios was 95.3% (95% CI 94.0%-96.6%) and occurred in the multivariable model with all covariates. Bias in VE estimates from DRS-adjusted models was low, ranging from -2.2% to 4.2%. However, the DRS-adjusted models underestimated the standard errors of VE estimates, with coverage sometimes below the 95% level. The lowest coverage in the DRS scenarios was 87.8% (95% CI 85.8%-89.8%) and occurred in the direct adjustment for the DRS model. The highest coverage in the DRS scenarios was 94.8% (95% CI 93.4%-96.2%) and occurred in the model that stratified on DRS. Although variation in the performance of VE estimates occurred across modeling strategies, variation in performance was also present across exposure groups. CONCLUSIONS Overall, models using a DRS to adjust for confounding performed adequately but not as well as the multivariable models that adjusted for covariates individually.
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Affiliation(s)
| | | | | | - Ned Lewis
- Vaccine Study Center, Northern California Division of Research, Kaiser Permanente, Oakland, CA, United States
| | - Brian E Dixon
- Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, IN, United States
- Fairbanks School of Public Health, Indiana University, Indianapolis, IN, United States
| | | | - William F Fadel
- Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, IN, United States
- Fairbanks School of Public Health, Indiana University, Indianapolis, IN, United States
| | - Inih J Essien
- HealthPartners Institute, Minneapolis, MN, United States
| | - Allison L Naleway
- Center for Health Research, Kaiser Permanente, Portland, OR, United States
| | - Edward Stenehjem
- Division of Infectious Diseases and Clinical Epidemiology, Intermountain Healthcare, Salt Lake City, UT, United States
| | - Toan C Ong
- Department of Biomedical Informatics, University of Colorado Anschutz Medical Campus, Aurora, CO, United States
| | - Manjusha Gaglani
- Department of Pediatrics, Section of Pediatric Infectious Diseases, Baylor Scott & White Health, Temple, TX, United States
- Department of Medical Education, Texas A&M University College of Medicine, Killeen, TX, United States
| | - Karthik Natarajan
- Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, NY, United States
- New York Presbyterian Hospital, New York, NY, United States
| | - Peter Embi
- Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, IN, United States
- Vanderbilt University Medical Center, Nashville, TN, United States
| | - Ryan E Wiegand
- National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States
| | - Ruth Link-Gelles
- National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States
| | - Mark W Tenforde
- National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States
| | - Bruce Fireman
- Vaccine Study Center, Northern California Division of Research, Kaiser Permanente, Oakland, CA, United States
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15
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Chen AA, Renouf EM, Dean CB, Hu XJ. The effects of deprivation, age, and regional differences in COVID-19 mortality from 2020 to 2022: a retrospective analysis of public provincial data. BMC Public Health 2025; 25:148. [PMID: 39810147 PMCID: PMC11730143 DOI: 10.1186/s12889-024-21031-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/01/2023] [Accepted: 12/09/2024] [Indexed: 01/16/2025] Open
Abstract
BACKGROUND Coronavirus disease (COVID-19) quickly spread around the world after its initial identification in Wuhan, China in 2019 and became a global public health crisis. COVID-19 related hospitalizations and deaths as important disease outcomes have been investigated by many studies while less attention has been given to the relationship between these two outcomes at a public health unit level. In this study, we aim to establish the relationship of counts of deaths and hospitalizations caused by COVID-19 over time across 34 public health units in Ontario, Canada, taking demographic, geographic, socio-economic, and vaccination variables into account. METHODS We analyzed daily data of the 34 health units in Ontario between March 1, 2020 and June 30, 2022. Associations between numbers of COVID-19 related deaths and hospitalizations were explored over three subperiods according to the availability of vaccines and the dominance of the Omicron variant in Ontario. A generalized additive model (GAM) was fit in each subperiod. Heterogeneity across public health units was formulated via a random intercept in each of the models. RESULTS Mean daily COVID-19 deaths increased quickly as daily hospitalizations increased, particularly when daily hospitalizations were less than 20. In all the subperiods, mean daily deaths of a public health unit was significantly associated with its population size and the proportion of confirmed cases in subjects over 60 years old. The proportion of fully vaccinated (2 doses of primary series) people in the 60 + age group was a significant factor after the availability of the COVID-19 vaccines. The deprivation index, a measure of poverty, had a significantly positive effect on COVID-19 mortality after the dominance of the Omicron variant in Ontario. Quantification of these effects was provided, including effects related to public health units. CONCLUSIONS The differences in COVID-19 mortality across health units decreased over time, after adjustment for other covariates. In the last subperiod when most public health protections were released and the Omicron variant dominated, the least advantaged group might suffer higher COVID-19 mortality. Interventions such as paid sick days and cleaner indoor air should be made available to counter lifting of health protections.
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Affiliation(s)
- Anqi A Chen
- Department of Statistics and Actuarial Science, Simon Fraser University, Burnaby, BC, V5A 1S6, Canada.
| | - Elizabeth M Renouf
- Department of Civil Engineering, University of Ottawa, Ottawa, ON, K1N 6N5, Canada
| | - Charmaine B Dean
- Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, ON, N2L 3G1, Canada
| | - X Joan Hu
- Department of Statistics and Actuarial Science, Simon Fraser University, Burnaby, BC, V5A 1S6, Canada
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16
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Yskak A, Sokharev Y, Zhumalynov K, Koneva E, Afanasyeva N, Borodulin D, Babaskin D, Nugmanov A, Nurushev M, Chashkov V. Hormonal Implications of SARS-CoV-2: A Review of Endocrine Disruptions. SCIENTIFICA 2025; 2025:7305185. [PMID: 39830837 PMCID: PMC11742418 DOI: 10.1155/sci5/7305185] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/15/2024] [Revised: 04/27/2024] [Accepted: 11/22/2024] [Indexed: 01/22/2025]
Abstract
To improve medical care and rehabilitation algorithms for patients affected by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), it is important to evaluate and summarize the available data on the effect of coronavirus infection (COVID-19) on the endocrine system. The purpose of this review was to study the effect of COVID-19 on the endocrine system. The scientific novelty of this study is the evaluation of the effect of coronavirus infection on the endocrine system and the potential effect of hormones on susceptibility to COVID-19. The results of this review show that the endocrine system is vulnerable to disorders caused by COVID-19, mainly thyroid dysfunction and hyperglycemia. The information in the published literature mentioned here contains some unclear aspects and contradictory data, but much remains to be studied and clarified regarding the impact of COVID-19 on the endocrine system. In particular, this concerns the study of the hyperglycemic status of patients who have had coronavirus infection, which is extremely important for the future metabolic health of COVID-19 survivors. This review contributes to the scientific discourse by systematically synthesizing disparate studies to identify patterns, gaps, and emerging trends in the literature concerning the effects of COVID-19 on the endocrine system. By integrating these findings, this study offers a novel perspective on potential hormonal interactions influencing COVID-19 susceptibility and outcomes, proposing new hypotheses and frameworks for future research.
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Affiliation(s)
- Aliya Yskak
- Research Institute of Applied Biotechnology, Akhmet Baitursynuly Kostanay Regional University, Kostanay, Kazakhstan
- Faculty of Soil Science, Lomonosov Moscow State University, Moscow, Russia
| | - Yevgeniy Sokharev
- Pathological Anatomy Department, Municipal State Company “Kostanay Regional Pathoanatomical Bureau” of the Health Department of the Akimat of the Kostanay Region, Kostanay, Kazakhstan
| | - Kuanysh Zhumalynov
- Department of Natural Sciences, Akhmet Baitursynuly Kostanay Regional University, Kostanay, Kazakhstan
| | - Elizaveta Koneva
- Department of Sports Medicine and Medical Rehabilitation, Sechenov University, Moscow, Russia
| | - Natalia Afanasyeva
- Resource Center “Medical Sechenov Pre-University”, Sechenov University, Moscow, Russia
| | - Dmitri Borodulin
- Department of Technology of Storage and Processing of Fruits, Vegetables and Plant Growing Products, Russian State Agrarian University-Moscow Timiryazev Agricultural Academy, Moscow, Russia
| | | | - Almabek Nugmanov
- Department of Natural Sciences, Akhmet Baitursynuly Kostanay Regional University, Kostanay, Kazakhstan
| | - Murat Nurushev
- Higher School of Natural Sciences, Astana International University, Astana, Kazakhstan
| | - Vadim Chashkov
- Department of Natural Sciences, Akhmet Baitursynuly Kostanay Regional University, Kostanay, Kazakhstan
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17
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Debbag R, Rudin D, Ceddia F, Watkins J. The Impact of Vaccination on COVID-19, Influenza, and Respiratory Syncytial Virus-Related Outcomes: A Narrative Review. Infect Dis Ther 2025; 14:63-97. [PMID: 39739199 PMCID: PMC11724835 DOI: 10.1007/s40121-024-01079-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/03/2024] [Accepted: 11/06/2024] [Indexed: 01/02/2025] Open
Abstract
Vaccination represents a core preventive strategy for public health, with interrelated and multifaceted effects across health and socioeconomic domains. Beyond immediate disease prevention, immunization positively influences downstream health outcomes by mitigating complications of preexisting comorbidities and promoting healthy aging. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza virus, and respiratory syncytial virus (RSV) are common respiratory viruses responsible for broad societal cost and substantial morbidity and mortality, particularly among at-risk individuals, including older adults and people with frailty or certain comorbid conditions. In this narrative review, we summarize the overall impact of vaccination for these 3 viruses, focusing on mRNA vaccines, each of which exhibits unique patterns of infection, risk, and transmission dynamics, but collectively represent a target for preventive strategies. Vaccines for COVID-19 (caused by SARS-CoV-2) and influenza are effective against the most severe outcomes, such as hospitalization and death; these vaccines represent the most potent and cost-effective interventions for the protection of population and individual health against COVID-19 and influenza, particularly for older adults and those with comorbid conditions. Based on promising results of efficacy for the prevention of RSV-associated lower respiratory tract disease, the first RSV vaccines were approved in 2023. Immunization strategies should account for various factors leading to poor uptake, including vaccine hesitancy, socioeconomic barriers to access, cultural beliefs, and lack of knowledge of vaccines and disease states. Coadministration of vaccines and combination vaccines, such as multicomponent mRNA vaccines, offer potential advantages in logistics and delivery, thus improving uptake and reducing barriers to adoption of new vaccines. The success of the mRNA vaccine platform was powerfully demonstrated during the COVID-19 pandemic; these and other new approaches show promise as a means to overcome existing challenges in vaccine development and to sustain protection against viral changes over time.A graphical abstract and video abstract is available with this article.
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Affiliation(s)
- Roberto Debbag
- Latin American Vaccinology Society, Buenos Aires, Argentina
| | | | | | - John Watkins
- Department of Population Medicine, Cardiff University, Cardiff, UK.
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18
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Ganesh PS, Pathoor NN, Gopal RK, Viswanathan A, Shankar EM. Letter to the editor regarding "Influenza vaccination and COVID-19 infection risk and disease severity: A systematic review and multilevel meta-analysis of prospective studies". Am J Infect Control 2025; 53:167. [PMID: 39743345 DOI: 10.1016/j.ajic.2024.08.024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/28/2024] [Accepted: 08/31/2024] [Indexed: 01/04/2025]
Affiliation(s)
- Pitchaipillai Sankar Ganesh
- Department of Microbiology, Centre for infectious Diseases, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences (SIMATS), Saveetha University (Deemed to be University), Chennai, Tamil Nadu, India.
| | - Naji Naseef Pathoor
- Department of Microbiology, Centre for infectious Diseases, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences (SIMATS), Saveetha University (Deemed to be University), Chennai, Tamil Nadu, India
| | - Rajesh Kanna Gopal
- Department of Microbiology, Centre for infectious Diseases, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences (SIMATS), Saveetha University (Deemed to be University), Chennai, Tamil Nadu, India
| | - Akshaya Viswanathan
- Department of Microbiology, Centre for infectious Diseases, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences (SIMATS), Saveetha University (Deemed to be University), Chennai, Tamil Nadu, India
| | - Esaki Muthu Shankar
- Infection and Inflammation, Department of Biotechnology, Central University of Tamil Nadu, Thiruvarur, India
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19
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Serrano-Ortiz Á, Romero-Cabrera JL, Monserrat Villatoro J, Cordero-Ramos J, Ruiz-Montero R, Ritoré Á, Dopazo J, Del Diego Salas J, García Sánchez V, Salcedo-Leal I, Armengol de la Hoz MÁ, Túnez I, Guzmán MÁ. Assessing COVID-19 Vaccine Effectiveness and Risk Factors for Severe Outcomes through Machine Learning Techniques: A Real-World Data Study in Andalusia, Spain. J Epidemiol Glob Health 2024; 14:1504-1517. [PMID: 39527397 PMCID: PMC11652453 DOI: 10.1007/s44197-024-00298-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/28/2023] [Accepted: 09/03/2024] [Indexed: 11/16/2024] Open
Abstract
BACKGROUND COVID-19 vaccination has become a pivotal global strategy in managing the pandemic. Despite COVID-19 no longer being classified as a Public Health Emergency of International Concern, the virus continues affecting people worldwide. This study aimed to evaluate risk factors and vaccine effectiveness on COVID-19-related hospital admissions, intensive care unit (ICU) admission and mortality within the Andalusian population throughout the pandemic. METHODS From March 2020 to April 2022, 671,229 individuals, out of 9,283,485 with electronic health records in Andalusia, experienced SARS-CoV-2 infection and were included in the analysis. Data on demographics, medical history, vaccine administration, and hospitalization records were collected. Associations between medical history, COVID-19 vaccines, and COVID-19 outcomes were assessed. RESULTS Our study identified 48,196 hospital admissions, 5,057 ICU admissions, and 11,289 deaths linked to COVID-19. Age, male sex, and chronic diseases were identified as risk factors, while the COVID-19 vaccine demonstrated protective effects, although with reduced effectiveness during the omicron variant period. However, the risk for these outcomes increased over time after receiving the last vaccine dose, particularly after six months, especially among those aged 60 or older. CONCLUSION The global health challenge of COVID-19 persists, marked by emerging variants with higher virulence and severity, particularly among the unvaccinated and those beyond six months post-vaccination, especially those aged 60 and above. These findings highlight the need for robust surveillance systems targeting new variants and administering booster doses, particularly for individuals aged 60 or older with underlying health conditions, to mitigate the global burden of COVID-19.
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Affiliation(s)
- Álvaro Serrano-Ortiz
- Preventive Medicine and Public Health Unit, Reina Sofía University Hospital, Córdoba, Spain
- Preventive Medicine and Public Health Research Group, Maimonides Biomedical Research Institute of Córdoba (IMIBIC), Córdoba, Spain
- Preventive Medicine and Public Health Unit, Healthcare Management Area: South of Córdoba, Cabra, Córdoba, Spain
| | - Juan Luis Romero-Cabrera
- Lipids and Atherosclerosis Unit, Maimonides Biomedical Research Institute of Córdoba (IMIBIC), Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain
- CIBEROBN (CIBER in Physiopathology of Obesity and Nutrition), Instituto de Salud Carlos III, Madrid, Spain
| | - Jaime Monserrat Villatoro
- Health District of Córdoba and Guadalquivir, Córdoba, Spain
- Maimonides Biomedical Research Institute of Córdoba (IMIBIC), Córdoba, Spain
| | - Jaime Cordero-Ramos
- Pharmaceutical Management Department, Extremadura Health Service, Mérida, Spain
- Hospital Pharmacy, Virgen Macarena University Hospital, Seville, Spain
- Institute of Biomedicine of Seville (IBiS)/University Hospital Virgen del Rocío/CSIC/University of Sevilla, Seville, Spain
| | - Rafael Ruiz-Montero
- Preventive Medicine and Public Health Unit, Reina Sofía University Hospital, Córdoba, Spain
- Preventive Medicine and Public Health Research Group, Maimonides Biomedical Research Institute of Córdoba (IMIBIC), Córdoba, Spain
- Department of Medical and Surgical Sciences, University of Córdoba, Córdoba, Spain
| | - Álvaro Ritoré
- Big Data Department, PMC-FPS, Regional Ministry of Health and Consumer Affairs, Seville, Spain
| | - Joaquín Dopazo
- Institute of Biomedicine of Seville (IBiS)/University Hospital Virgen del Rocío/CSIC/University of Sevilla, Seville, Spain
- Computational Medicine Platform, Andalusian Public Foundation Progress and Health-FPS, Seville, Spain
| | - Jorge Del Diego Salas
- Directorate General of Public Health and Pharmaceutical Regulation, Ministry of Health and Consumer Affairs of the Regional Government of Andalusia, Seville, Spain
| | - Valle García Sánchez
- Management Directorate of Andalusian Health Service, Ministry of Health and Consumer Affairs of the Regional Government of Andalusia, Seville, Spain
- Reina Sofía University Hospital, Córdoba, Spain
| | - Inmaculada Salcedo-Leal
- Preventive Medicine and Public Health Unit, Reina Sofía University Hospital, Córdoba, Spain
- Preventive Medicine and Public Health Research Group, Maimonides Biomedical Research Institute of Córdoba (IMIBIC), Córdoba, Spain
- Department of Medical and Surgical Sciences, University of Córdoba, Córdoba, Spain
| | | | - Isaac Túnez
- Maimonides Biomedical Research Institute of Córdoba (IMIBIC), Córdoba, Spain
- Reina Sofía University Hospital, Córdoba, Spain
- Department of Biochemistry and Molecular Biology, University of Córdoba, Córdoba, Spain
- General Secretariat of Public Health and Research, Development and Innovation in Health, Ministry of Health and Consumer Affairs of the Regional Government of Andalusia, Seville, Spain
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Williams BS, Piasecki TM, Fiore MC, Conner KL, Slutske WS. Hospital outcomes for young adults with COVID-19. GLOBAL EPIDEMIOLOGY 2024; 8:100155. [PMID: 39100963 PMCID: PMC11296004 DOI: 10.1016/j.gloepi.2024.100155] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/03/2024] [Revised: 07/02/2024] [Accepted: 07/03/2024] [Indexed: 08/06/2024] Open
Abstract
Background Older adults are at higher risk of severe outcomes from COVID-19 with comorbidities increasing such risk. Much less is known about the outcomes of young adults with COVID-19 despite their having had high infection rates. Objectives Our objective was to determine outcomes of hospitalized young adults with COVID-19 infection including rates of oxygen use, mortality, ICU admission, intubation, duration of hospitalization, and factors associated with adverse outcomes. Study design This retrospective cohort study included EHR data from 21 health systems in the United States on 18-29-year-olds hospitalized with COVID-19 from March 1, 2020 - January 31, 2022. Oxygen need was used to identify symptomatic COVID-19. Rates for mortality, ICU admission, and intubation were calculated for the symptomatic and asymptomatic groups. Effects of demographic and health characteristics on outcomes were assessed as were changes in hospital outcomes over time. Results Our sample included 9871 young adults hospitalized with COVID-19; 35% required oxygen. Of those who required oxygen, 53.5% were female, 23.7% had an anxiety disorder, 2.6% died (n = 89), 27.7% were admitted to the ICU (n = 955), and 15.8% were intubated (n = 547). A past-year history of any cancer was associated with a 2.1 times increased odds of death. Vaccination was associated with a >40% reduction in the odds of ICU admission. Mortality rates did not change significantly across the study period. Conclusions COVID-19 caused significant morbidity and mortality in hospitalized young adults who required oxygen. A cancer history was associated with increased risk of death. Vaccination appeared to have had a protective effect on illness severity.
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Affiliation(s)
- Brian S. Williams
- Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health
- Division of Hospital Medicine and Complex Care, Department of Pediatrics, University of Wisconsin School of Medicine and Public Health
- Division of Hospital Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health
| | - Thomas M. Piasecki
- Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health
- Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health
| | - Michael C. Fiore
- Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health
- Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health
| | - Karen L. Conner
- Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health
- Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health
| | - Wendy S. Slutske
- Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health
- Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health
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21
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Dowd-Green C, Brown D, Wilson A, Streiff M. Supratherapeutic INR During Treatment With Nirmatrelvir/Ritonavir and Warfarin and Acute Illness With COVID-19: A Case Report. J Pharm Pract 2024; 37:1414-1418. [PMID: 38803049 DOI: 10.1177/08971900241257296] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/29/2024]
Abstract
Background: Several studies have examined INR fluctuations using pharmacokinetic (PK) models or post-hoc INR values after completing nirmatrelvir/ritonavir, but further study of the effects of the drug interaction with warfarin during treatment is necessary. Case Summary: Nirmatrelvir/ritonavir is largely utilized in the outpatient setting so data regarding INR trends in hospitalized patients on warfarin is limited. However, many who receive nirmatrelvir/ritonavir outpatient experience difficulty with presenting to clinic for INR checks due to feeling acutely ill along with isolation precautions. We present the case of a patient receiving warfarin and utilizing home INR testing for monitoring. After diagnosis of coronavirus disease of 2019 (COVID-19), she was started on nirmatrelvir/ritonavir on day five after testing positive. Most recent INR prior to the start of therapy was 2.7 and had been stable on the same dose for months prior to infection. On day two of nirmatrelvir/ritonavir, her INR rose to 4.0 on home point of care INR testing. Despite reducing her dose of warfarin by 15%, her INR remained supratherapeutic the day after completing nirmatrelvir/ritonavir (4.0) and for several checks after. One month after completion of therapy, her INR returned to therapeutic levels. Practice Implications: While PK models and case series have hypothesized both potential increases or decreases in INR with the nirmatrelvir/ritonavir and warfarin interaction, COVID-19 infection itself can cause several pharmacodynamic changes which can increase INR, including decreased appetite and, in severe cases, organ dysfunction. This case provides real-world insight into the drug interaction between nirmatrelvir/ritonavir and the drug-disease state interaction between warfarin and COVID-19.
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Affiliation(s)
| | - Dannielle Brown
- Department of Pharmacy, The Johns Hopkins Hospital, Baltimore, MD, USA
| | | | - Michael Streiff
- Division of Hematology, Department of Medicine, Johns Hopkins University and Johns Hopkins Medicine, Baltimore, MD, USA
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Hovind MJ, Berdal JE, Dalgard O, Lyngbakken MN. Impact of antibiotic therapy in patients with respiratory viral infections: a retrospective cohort study. Infect Dis (Lond) 2024; 56:1031-1039. [PMID: 39042560 DOI: 10.1080/23744235.2024.2375592] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/07/2024] [Revised: 06/17/2024] [Accepted: 06/28/2024] [Indexed: 07/25/2024] Open
Abstract
OBJECTIVES The impact of antibiotics in patients with positive polymerase chain reaction (PCR) for respiratory viruses without evidence of a respiratory bacterial co-infection is largely unknown. The aim of this study was to assess the association of antibiotics on 30-day mortality and length of hospital stay in patients with an acute respiratory infection and PCR documented presence of respiratory viruses. METHODS We conducted a retrospective cohort study of adult patients admitted to hospital between 2012 and 2021 with positive PCR for influenza virus (H3N2, H1N1, influenza B), respiratory syncytial virus, human metapneumovirus or severe acute respiratory syndrome coronavirus 2. We used logistic regression, the Kaplan-Meier estimator and Poisson's regression to assess the impact of antibiotic therapy on outcomes. RESULTS Among 3979 patients, 67.7% received antibiotics. In adjusted analyses, antibiotics initiated in the emergency department (adjusted OR 1.23, 95% CI 0.77-1.96) and days of antibiotic therapy (adjusted OR per day of therapy 0.98, 95% CI 0.95-1.00) had no significant impact on mortality, whereas antibiotics initiated later during admission (adjusted OR 2.25, 95% CI 1.26-4.02) was associated with increased mortality. Patients prescribed antibiotics had longer duration of hospital admission. CONCLUSIONS We observed no protective association between in-hospital antibiotic therapy and outcomes, suggesting overuse of antibiotics in respiratory infections with proven respiratory viruses. A restrictive antibiotic strategy may be warranted.
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Affiliation(s)
- M J Hovind
- Department of Infectious Diseases, Akershus University Hospital, Lørenskog, Norway
- Institute for Clinical Medicine, University of Oslo, Oslo, Norway
| | - J E Berdal
- Department of Infectious Diseases, Akershus University Hospital, Lørenskog, Norway
- Institute for Clinical Medicine, University of Oslo, Oslo, Norway
| | - O Dalgard
- Department of Infectious Diseases, Akershus University Hospital, Lørenskog, Norway
- Institute for Clinical Medicine, University of Oslo, Oslo, Norway
| | - M N Lyngbakken
- Department of Infectious Diseases, Akershus University Hospital, Lørenskog, Norway
- Institute for Clinical Medicine, University of Oslo, Oslo, Norway
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23
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Lucinde RK, Gathuri H, Isaaka L, Ogero M, Mumelo L, Kimego D, Mbevi G, Wanyama C, Otieno EO, Mwakio S, Saisi M, Isinde E, Oginga IN, Wachira A, Manuthu E, Kariuki H, Nyikuli J, Wekesa C, Otedo A, Bosire H, Okoth SB, Ongalo W, Mukabi D, Lusamba W, Muthui B, Adembesa I, Mithi C, Sood M, Ahmed N, Gituma B, Giabe M, Omondi C, Aman R, Amoth P, Kasera K, Were F, Nganga W, Berkley JA, Tsofa B, Mwangangi J, Bejon P, Barasa E, English M, Scott JAG, Akech S, Kagucia EW, Agweyu A, Etyang AO. Prospective clinical surveillance for severe acute respiratory illness and COVID-19 vaccine effectiveness in Kenyan hospitals during the COVID-19 pandemic. BMC Infect Dis 2024; 24:1246. [PMID: 39501217 PMCID: PMC11536953 DOI: 10.1186/s12879-024-10140-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/02/2024] [Accepted: 10/29/2024] [Indexed: 11/09/2024] Open
Abstract
BACKGROUND There are limited data from sub-Saharan Africa describing the demographic characteristics, clinical features and outcome of patients admitted to public hospitals with severe acute respiratory infections during the COVID-19 pandemic. METHODS We conducted a prospective longitudinal hospital-based sentinel surveillance between May 2020 and December 2022 at 16 public hospitals in Kenya. All patients aged above 18 years admitted to adult medical wards in the participating hospitals were included. We collected data on demographic and clinical characteristics, SARS-CoV-2 infection and COVID-19 vaccination status and, admission episode outcomes. We determined COVID-19 vaccine effectiveness (VE) against admission with SARS-CoV-2 positive severe acute respiratory illness (SARI) (i.e., COVID-19) and progression to inpatient mortality among patients admitted with SARI, using a test-negative case control design. RESULTS Of the 52,636 patients included in the study, 17,950 (34.1%) were admitted with SARI. The median age was 50 years. Patients were equally distributed across sexes. Pneumonia was the most common diagnosis at discharge. Hypertension, Human Immunodeficiency Virus (HIV) infection and Diabetes Mellitus were the most common chronic comorbidities. SARS-CoV-2 test results were positive in 2,364 (27.9%) of the 8,471 patients that underwent testing. After adjusting for age, sex and presence of a chronic comorbidity, SARI patients were more likely to progress to inpatient mortality compared to non-SARI patients regardless of their SARS-CoV-2 infection status (adjusted odds ratio (aOR) for SARI and SARS-CoV-2 negative patients 1.22, 95% CI 1.10-1.37; and aOR for SARI and SARS-CoV-2 positive patients 1.32, 95% CI 1.24-1.40). After adjusting for age, sex and presence of a chronic comorbidity, COVID-19 VE against progression to inpatient mortality following admission with SARI for those with a confirmed vaccination status was 0.59 (95% CI 0.27-0.77). CONCLUSION We have provided a comprehensive description of the demographic and clinical pattern of admissions with SARI in Kenyan hospitals during the COVID-19 pandemic period as well as the COVID-19 VE for these patients. These data were useful in providing situational awareness during the first three years of the pandemic in Kenya and informing national response measures.
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Affiliation(s)
| | - Henry Gathuri
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
| | - Lynda Isaaka
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
| | - Morris Ogero
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
| | | | - Dennis Kimego
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
| | - George Mbevi
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
| | - Conrad Wanyama
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
| | | | - Stella Mwakio
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
| | - Metrine Saisi
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | - Isaac Adembesa
- Kenyatta University Teaching and Referral Hospital, Nairobi, Kenya
| | - Caroline Mithi
- Kenyatta University Teaching and Referral Hospital, Nairobi, Kenya
| | - Mohammed Sood
- Coast General Teaching and Referral Hospital, Mombasa, Kenya
| | | | | | - Matiko Giabe
- Kisii Teaching and Referral Hospital, Kisii, Kenya
| | - Charles Omondi
- Jaramogi Oginga Odinga Teaching and Referral Hospital, Kisumu, Kenya
| | - Rashid Aman
- Ministry of Health, Government of Kenya, Nairobi, Kenya
| | - Patrick Amoth
- Ministry of Health, Government of Kenya, Nairobi, Kenya
| | | | - Fred Were
- Kenya Paediatric Research Consortium, Nairobi, Kenya
| | - Wangari Nganga
- Presidential Policy & Strategy Unit, The Presidency, Government of Kenya, Nairobi, Kenya
| | - James A Berkley
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
- Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
| | - Benjamin Tsofa
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
| | | | - Philip Bejon
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
| | - Edwine Barasa
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
| | - Mike English
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
- Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
| | - John Athony Gerard Scott
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
- London School of Hygiene and Tropical Medicine, London, United Kingdom
| | - Samuel Akech
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
| | | | - Ambrose Agweyu
- KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya
- Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
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Tchakerian S, Besnard N, Brunot V, Moulaire V, Benchabane N, Platon L, Daubin D, Corne P, Machado S, Jung B, Bendiab E, Landreau L, Pelle C, Larcher R, Klouche K. Epidemiology, clinical and biological characteristics, and prognosis of critically ill COVID 19 patients: a single-center experience through 4 successive waves. Pneumonia (Nathan) 2024; 16:27. [PMID: 39497221 PMCID: PMC11536821 DOI: 10.1186/s41479-024-00144-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/04/2024] [Accepted: 08/26/2024] [Indexed: 11/07/2024] Open
Abstract
OBJECTIVE The aim of this study was to describe the characteristics of patients admitted to the intensive care unit with severe pneumonia due to SARS-CoV-2, comparing them according to successive waves, and to identify prognostic factors for morbidity and mortality. MATERIALS AND METHODS This single-center retrospective observational descriptive study was conducted from March 10, 2020, to October 17, 2021. All adult patients admitted with SARS-CoV-2 pneumonia presenting acute respiratory failure were included. COVID 19 diagnosis was confirmed by RT-PCR testing of respiratory specimens. The primary endpoint was ICU mortality. Secondary endpoints were the occurrence of ventilator-associated pneumonia (VAP) or bronchopulmonary aspergillosis. RESULTS Over the study period, 437 patients were included of whom 282 (65%) patients were ventilated for 9 [5;20] days. Among the studied population, 38% were treated for one or more episodes of VAP, and 22 (5%) for bronchopulmonary aspergillosis. ICU mortality was 26% in the first wave, then fell and stabilized at around 10% in subsequent waves (p = 0.02). Increased age, Charlson index, SOFA score and lactatemia on admission were predictive of mortality. Survival at 90 days was 85% (95% CI 82-88) and was unaffected by the presence of VAP. However, the occurrence of bronchopulmonary aspergillosis increased mortality to 36%. CONCLUSION In this study, we observed mortality in the lower range of those previously reported. Risk factors for mortality mainly included age and previous comorbidities. The prognosis of these critically ill Covid 19 patients improved over the four waves, underlining the likely beneficial effect of vaccination and dexamethasone.
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Affiliation(s)
- Sonia Tchakerian
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
| | - Noémie Besnard
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
| | - Vincent Brunot
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
| | - Valérie Moulaire
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
| | - Nacim Benchabane
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
| | - Laura Platon
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
| | - Delphine Daubin
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
| | - Philippe Corne
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
| | - Sonia Machado
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
| | - Boris Jung
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
- PhyMedExp, INSERM (French Institute of Health and Medical Research), CNRS (French National Centre for Scientific Research), University of Montpellier, School of Medicine, Montpellier, France
| | - Eddine Bendiab
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
| | - Liliane Landreau
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
| | - Corrine Pelle
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
| | - Romaric Larcher
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France
| | - Kada Klouche
- Department of Intensive Care Medicine, Lapeyronie University Hospital, University of Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France.
- PhyMedExp, INSERM (French Institute of Health and Medical Research), CNRS (French National Centre for Scientific Research), University of Montpellier, School of Medicine, Montpellier, France.
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Alves P, Bååth C, Manuel T, Almeida S, Källman U. Pressure ulcers during the COVID-19 pandemic in intensive care:A multicenter cohort study. J Tissue Viability 2024; 33:642-651. [PMID: 38937249 DOI: 10.1016/j.jtv.2024.06.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/29/2023] [Revised: 06/16/2024] [Accepted: 06/21/2024] [Indexed: 06/29/2024]
Abstract
AIM The objective of the present study is twofold: to describe the prevalence and incidence of pressure ulcers (PUs) among ICU patients during the COVID-19 pandemic, and to identify the risk factors associated with the development of PUs in this cohort of ICU patients. MATERIALS AND METHODS Retrospective cohort study of adult critical care patients admitted in two general ICUs of two different countries (Sweden and Portugal) between March 1st, 2020, and April 30th, 2021, through the analysis of the electronic health record database. The prevalence and incidence were calculated, and a multivariate logistic-regression model was used to calculate odds ratios (ORs), of possible risk factors of PU development. RESULTS The sample consisted of 1717 patients. The overall prevalence of PU was 15.3 %, and the incidence of ICU-acquired PUs was 14.1 %. Most of the pressure ulcers documented in this study were at the anterior part of the body (45.35 %) and regarding classification, Category 2 (38.40 %) and Category 3 (22.71 %) pressure ulcers together accounted for over fifty percent of the cases recorded. In the multivariate logistic regression model for PU, age, having COVID-19 (OR = 1.58, 95 % CI: 1.20-2.09), use of mechanical ventilation (OR = 1.49, 95 % CI: 1.13 = 1.97), use of vasopressors (OR = 1.31, 95 % CI: 1.00-1.70), having a Braden risk score ≤16 at admission (OR = 1.63; 95 % CI: 1.04-2.56), and length of stay (LOS) (OR = 1.43, 95 % CI 1.03-2.00 if LOS 90-260 h, OR = 2.34, 95 % CI: 1.63-3.35 if LOS >260 h) were associated with the likelihood of developing an ICU-acquired PUs. CONCLUSION When adjusted for covariates patients with COVID-19 had a higher risk for PU development during the ICU stay compared to patients without COVID-19. Health care personnel in ICU may consider incorporating COVID-19, age, use of mechanical ventilation, vasopressors and estimated LOS in addition to a comprehensive risk assessment including both a risk score and clinical assessment.
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Affiliation(s)
- Paulo Alves
- Universidade Católica Portuguesa | Wounds Research Lab - Centre for Interdisciplinary Research in Health, Portugal; Universidade Católica Portuguesa | School of Nursing of the Institute of Health Sciences, Porto, Portugal; Portuguese Wound Management Association (APTFeridas), Portugal.
| | - Carina Bååth
- Karlstad University, Department of Health Sciences, Karlstad, Sweden; Østfold University College, Faculty of Health, Welfare and Organization, Fredrikstad, Norway
| | - Tânia Manuel
- Universidade Católica Portuguesa | Wounds Research Lab - Centre for Interdisciplinary Research in Health, Portugal; Universidade Católica Portuguesa | School of Nursing of the Institute of Health Sciences, Porto, Portugal; Portuguese Wound Management Association (APTFeridas), Portugal
| | - Sofia Almeida
- Universidade Católica Portuguesa | Wounds Research Lab - Centre for Interdisciplinary Research in Health, Portugal; Universidade Católica Portuguesa | School of Nursing of the Institute of Health Sciences, Porto, Portugal
| | - Ulrika Källman
- Research Unit, FoUI Department, Södra Älvsborgs Hospital, Borås, Sweden; University of Gothenburg, Faculty of Sahlgrenska Academy, Institute of Health and Care Sciences, Gothenburg, Sweden
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Brambilla R, Gili R, Vigna Taglianti F, Lenzi J, Riccò M, Burioni R, Scarvaglieri M, Rocco R, Buttafuoco V, Cristaudo RMTA, Gori D. The Effectiveness of COVID-19 Vaccines During the Pre-Omicron and Omicron Periods: A Retrospective Test-Negative Case-Control Study. Vaccines (Basel) 2024; 12:1245. [PMID: 39591148 PMCID: PMC11598972 DOI: 10.3390/vaccines12111245] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/10/2024] [Revised: 10/25/2024] [Accepted: 10/30/2024] [Indexed: 11/28/2024] Open
Abstract
BACKGROUND The aim of this study was to estimate the effectiveness of original and bivalent COVID-19 vaccines in reducing COVID-19-associated hospitalizations among the adult population of Turin, Italy. METHODS We conducted a retrospective, test-negative, case-control study of 5768 adults aged ≥50 years who had symptoms that were consistent with COVID-19-like illness and were admitted to the hospitals of the Turin Health Unit network from 1 January 2021 to 31 January 2023. We evaluated the effectiveness of the vaccines that at the time of the study were authorized in the European Union (original/bivalent BNT162b2; original mRNA-1273; ChAdOx1-S; Ad26.COV2.S) by comparing the odds of a positive test for SARS-CoV-2 in vaccinated patients with the odds of a positive test in unvaccinated patients. The association between vaccination status, hospitalization, ICU admission and positive SARS-CoV-2 test was estimated by building multivariate adjusted logistic regression models. RESULTS During the predominance of the pre-Omicron variants, the vaccine effectiveness of two and three doses received in the last 120 days against COVID-19-associated hospitalizations was 93.6% (95% CI: 90.1 to 95.9) and 97.1% (95% CI: 90.8 to 99.1), respectively. During the predominance of the Omicron variant, the vaccine effectiveness of two and three doses was 26.6% (95% CI: -0.6 to 46.5) and 75.2% (95% CI: 68.1 to 80.7), respectively, and it rose to 88% (95% CI: 78.2 to 93.3) for four or five doses of the bivalent vaccine. CONCLUSIONS Our study confirms that the COVID-19 vaccines protect adult patients from hospitalizations, including the subgroup ≥80 years, also during the period of the Omicron variant's predominance.
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Affiliation(s)
- Romeo Brambilla
- Local Health Unit of Torino, Department of Prevention, Via Silvio Pellico 19, 10125 Turin, Italy
| | - Renata Gili
- Local Health Unit of Torino, Department of Prevention, Via Silvio Pellico 19, 10125 Turin, Italy
- Department of Microbiology and Virology, Università Vita Salute San Raffaele Medical School, Via Olgettina 58, 20132 Milan, Italy
| | - Federica Vigna Taglianti
- Department of Translational Medicine, University of Eastern Piedmont, Via Solaroli 17, 28100 Novara, Italy
| | - Jacopo Lenzi
- Department of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, 40126 Bologna, Italy
| | - Matteo Riccò
- AUSL–IRCCS di Reggio Emilia, Servizio di Prevenzione e Sicurezza Negli Ambienti di Lavoro (SPSAL), Local Health Unit of Reggio Emilia, 42122 Reggio Emilia, Italy
| | - Roberto Burioni
- Department of Microbiology and Virology, Università Vita Salute San Raffaele Medical School, Via Olgettina 58, 20132 Milan, Italy
| | | | - Rachele Rocco
- Local Health Unit of Torino, Department of Prevention, Via Silvio Pellico 19, 10125 Turin, Italy
| | - Vittorina Buttafuoco
- Local Health Unit of Torino, Department of Prevention, Via Silvio Pellico 19, 10125 Turin, Italy
| | | | - Davide Gori
- Department of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, 40126 Bologna, Italy
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Kopel H, Nguyen VH, Bogdanov A, Winer I, Boileau C, Ducruet T, Zeng N, Winer-Jones JP, Esposito DB, Bausch-Jurken M, Beck E, Bonafede M, Mansi JA. Comparative Effectiveness of the Bivalent (Original/Omicron BA.4/BA.5) mRNA COVID-19 Vaccines mRNA-1273.222 and BNT162b2 Bivalent in Adults with Underlying Medical Conditions in the United States. Vaccines (Basel) 2024; 12:1107. [PMID: 39460274 PMCID: PMC11511346 DOI: 10.3390/vaccines12101107] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/23/2024] [Revised: 09/16/2024] [Accepted: 09/23/2024] [Indexed: 10/28/2024] Open
Abstract
BACKGROUND/OBJECTIVES This retrospective cohort study evaluated the relative vaccine effectiveness (rVE) of two bivalent (original/Omicron BA.4/BA.5) vaccines mRNA-1273.222 versus the BNT162b2 Bivalent in preventing COVID-19-related outcomes in adults with underlying medical conditions associated with increased risk for severe COVID-19. METHODS In a linked electronic health record/claims dataset, US adults (≥18 years) with ≥1 underlying medical condition of interest who received either the bivalent vaccine between 31 August 2022 and 28 February 2023 were identified. The inverse probability of treatment weighting was used to adjust for cohort differences. Cohorts were followed up for COVID-19-related hospitalizations and outpatient encounters until 31 May 2023. Hazard ratios and rVEs were estimated using Cox regression. Subgroup analyses were performed on individuals with pre-specified comorbid conditions. RESULTS 757,572 mRNA-1273.222 and 1,204,975 BNT162b2 Bivalent recipients were identified. The adjusted rVE over a median follow-up of 198 days was 10.9% (6.2%-15.2%) against COVID-19-related hospitalization and 3.2% (1.7%-4.7%) against COVID-19-related outpatient encounters. rVE estimates for COVID-19 hospitalizations among subgroups with comorbid conditions were as follows: diabetes 15.1% (8.7%-21.0%), cerebro- and cardiovascular disease 14.7% (9.0%-20.1%), chronic lung disease 11.9% (5.1%-18.2%), immunocompromised 15.0% (7.2%-22.2%), chronic kidney disease 8.4% (0.5%-15.7%). CONCLUSIONS Overall, among adults with underlying medical conditions, mRNA-1273.222 was more effective than BNT162b2 Bivalent, especially in preventing COVID-19-related hospitalizations.
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Affiliation(s)
- Hagit Kopel
- Moderna, Inc., Cambridge, MA 02139, USA; (H.K.); (D.B.E.); (M.B.-J.); (E.B.)
| | - Van Hung Nguyen
- VHN Consulting Inc., Montreal, QC H2V 3L8, Canada; (V.H.N.); (C.B.); (T.D.)
| | - Alina Bogdanov
- Veradigm, Chicago, IL 60654, USA; (A.B.); (N.Z.); (J.P.W.-J.); (M.B.)
| | - Isabelle Winer
- Veradigm, Chicago, IL 60654, USA; (A.B.); (N.Z.); (J.P.W.-J.); (M.B.)
| | - Catherine Boileau
- VHN Consulting Inc., Montreal, QC H2V 3L8, Canada; (V.H.N.); (C.B.); (T.D.)
| | - Thierry Ducruet
- VHN Consulting Inc., Montreal, QC H2V 3L8, Canada; (V.H.N.); (C.B.); (T.D.)
| | - Ni Zeng
- Veradigm, Chicago, IL 60654, USA; (A.B.); (N.Z.); (J.P.W.-J.); (M.B.)
| | | | - Daina B. Esposito
- Moderna, Inc., Cambridge, MA 02139, USA; (H.K.); (D.B.E.); (M.B.-J.); (E.B.)
| | - Mary Bausch-Jurken
- Moderna, Inc., Cambridge, MA 02139, USA; (H.K.); (D.B.E.); (M.B.-J.); (E.B.)
| | - Ekkehard Beck
- Moderna, Inc., Cambridge, MA 02139, USA; (H.K.); (D.B.E.); (M.B.-J.); (E.B.)
| | - Machaon Bonafede
- Veradigm, Chicago, IL 60654, USA; (A.B.); (N.Z.); (J.P.W.-J.); (M.B.)
| | - James A. Mansi
- Moderna, Inc., Cambridge, MA 02139, USA; (H.K.); (D.B.E.); (M.B.-J.); (E.B.)
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Pather S, Charpentier N, van den Ouweland F, Rizzi R, Finlayson A, Salisch N, Muik A, Lindemann C, Khanim R, Abduljawad S, Smith ER, Gurwith M, Chen RT. A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine. Vaccine 2024; 42:126165. [PMID: 39197299 DOI: 10.1016/j.vaccine.2024.126165] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/23/2024] [Accepted: 07/18/2024] [Indexed: 09/01/2024]
Abstract
The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group evaluates the safety and other key features of new platform technology vaccines, including nucleic acid (RNA and DNA) vaccines. This manuscript uses the BRAVATO template to report the key considerations for a benefit-risk assessment of the coronavirus disease 2019 (COVID-19) mRNA-based vaccine BNT162b2 (Comirnaty®, or Pfizer-BioNTech COVID-19 vaccine) including the subsequent Original/Omicron BA.1, Original/Omicron BA.4-5 and Omicron XBB.1.5 variant-adapted vaccines developed by BioNTech and Pfizer to protect against COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Initial Emergency Use Authorizations or conditional Marketing Authorizations for the original BNT162b2 vaccine were granted based upon a favorable benefit-risk assessment taking into account clinical safety, immunogenicity, and efficacy data, which was subsequently reconfirmed for younger age groups, and by real world evidence data. In addition, the favorable benefit-risk assessment was maintained for the bivalent vaccines, developed against newly arising SARS-CoV-2 variants, with accumulating clinical trial data.
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Affiliation(s)
| | | | | | | | | | | | | | | | | | | | - Emily R Smith
- Brighton Collaboration, a program of the Task Force for Global Health, Decatur, GA, USA.
| | - Marc Gurwith
- Brighton Collaboration, a program of the Task Force for Global Health, Decatur, GA, USA
| | - Robert T Chen
- Brighton Collaboration, a program of the Task Force for Global Health, Decatur, GA, USA
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Tuhkuri Matvejeff A, Laitinen A, Korhonen M, Oksanen LM, Geneid A, Sanmark E, Vuorinen V. Superspreading of SARS-CoV-2 at a choir rehearsal in Finland-A computational fluid dynamics view on aerosol transmission and patient interviews. PLoS One 2024; 19:e0302250. [PMID: 39264883 PMCID: PMC11392323 DOI: 10.1371/journal.pone.0302250] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/06/2023] [Accepted: 03/31/2024] [Indexed: 09/14/2024] Open
Abstract
INTRODUCTION COVID-19 pandemic has highlighted the role of aerosol transmission and the importance of superspreading events. We analyzed a choir rehearsal in November 2020, where all participants, except one who had recently earlier recovered from COVID-19, were infected. We explore the risk factors for severe disease in this event and model the aerosol dispersion in the rehearsal room. MATERIALS AND METHODS Characteristics of participants were collected by interviews and supplemented with patient records. A computational simulation of aerosol distribution in the rehearsal room and the efficacy of potential safety measures was conducted using the Large-Eddy Simulation approach. Infection risk was studied by analyzing quanta emission and exposure with the Wells-Riley equation. RESULTS The simulation showed that airborne transmission likely explains this mass contagion event. Every singer was exposed to the virus in only 5 min from the beginning of the rehearsal, and maximum concentration levels were reached at 20 min the concentration levels started to approach a steady state after 20 min. Although concentration differences existed in the room, risk levels near (1 m) and far (5 m) from the aerosol source were similar for certain singers. Modeling indicated infection risk levels of 70-100% after one hour; the risk would have been considerably reduced by wearing high-filtration respirators. Age and pre-existing comorbidities predicted more severe disease. The high incidence of illness may be partly attributed to the relatively high median age of individuals. Additionally, those admitted to the hospital had multiple underlying health conditions that predispose them to more severe disease. CONCLUSIONS Airborne transmission and indoor space can explain this mass exposure event. High-filtration respirators could have prevented some infections. The importance of safety distances diminishes the longer the indoor event. The concept of safety distance is challenging, as our study suggests that long range airborne transmission may occur in indoor events with extended duration. We encourage informing the public, especially persons at risk, of safety measures during epidemics.
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Affiliation(s)
- Anna Tuhkuri Matvejeff
- Department of Otorhinolaryngology and Phoniatrics - Head and Neck Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
| | - Alpo Laitinen
- Department of Mechanical Engineering, Aalto University, Espoo, Finland
| | - Marko Korhonen
- Department of Mechanical Engineering, Aalto University, Espoo, Finland
| | - Lotta-Maria Oksanen
- Department of Otorhinolaryngology and Phoniatrics - Head and Neck Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
| | - Ahmed Geneid
- Department of Otorhinolaryngology and Phoniatrics - Head and Neck Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
| | - Enni Sanmark
- Department of Otorhinolaryngology and Phoniatrics - Head and Neck Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
| | - Ville Vuorinen
- Department of Mechanical Engineering, Aalto University, Espoo, Finland
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Fernández-Trujillo L, Galindo-Sánchez JS, Cediel A, García CA, Morales EI, Largo J, Amezquita-Dussan MA. Six and twelve-month respiratory outcomes in a cohort of severe and critical COVID-19 survivors: A prospective monocentric study in Latin America. SAGE Open Med 2024; 12:20503121241275369. [PMID: 39263637 PMCID: PMC11388297 DOI: 10.1177/20503121241275369] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/15/2024] [Accepted: 07/24/2024] [Indexed: 09/13/2024] Open
Abstract
Introduction Severe COVID-19 can result in long-term sequelae known as "chronic COVID," characterized by a wide range of persistent physical and mental symptoms. Chest imaging and pulmonary function test alterations have been observed in recovered patients. Most studies focus on up to a 3-month follow-up after symptom onset or hospital discharge, with few reports on long-term follow-up and limited evidence regarding disease progression in Latin America. Methods This study aims to describe the clinical characteristics and changes in pulmonary function, imaging, and quality of life in severe and critical COVID-19 patients requiring ICU admission in a high-complexity hospital in Latin America. A prospective cohort of survivors underwent clinical, radiological, pulmonary function, and quality of life assessments 6 and 12 months post-discharge. Results One hundred twelve patients were included, all of whom attended the 6-month follow-up, and 99 returned for the 12-month follow-up. Most subjects had no previous respiratory symptoms or significant medical history. At the end of the follow-up period, 74% of the patients showed interstitial infiltrates in chest tomography and a higher frequency of fibroatelectatic tracts and parenchymal bands. Pulmonary function tests returned to normal ranges, except for carbon monoxide diffusion, but no altered scores were reported in the questionnaires. Conclusion Despite residual radiological findings, most parameters studied in severe and critical COVID-19 survivors improved over the 12-month follow-up period. Regardless of the imaging abnormalities, the improvement in variables such as symptomatic relief and normal pulmonary function suggests that these alterations are transient. Carbon monoxide diffusion did not normalize by the end of the follow-up, which is consistent with the abnormalities reported in multiple studies, indicating a potential disease-related pattern.
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Affiliation(s)
- Liliana Fernández-Trujillo
- Department of Internal Medicine, Pulmonology Service, Fundación Valle del Lili, Cali, Colombia
- Faculty of Health Sciences, Universidad Icesi, Cali, Colombia
| | | | - Angie Cediel
- Department of Diagnostic Imaging Fundación Valle del Lili, Cali, Colombia
- Faculty of Health Sciences, Universidad Icesi, Cali, Colombia
| | - Carlos A García
- Department of Diagnostic Imaging Fundación Valle del Lili, Cali, Colombia
- Faculty of Health Sciences, Universidad Icesi, Cali, Colombia
| | - Eliana I Morales
- Department of Internal Medicine, Pulmonology Service, Fundación Valle del Lili, Cali, Colombia
- Faculty of Health Sciences, Universidad Icesi, Cali, Colombia
| | - Jessica Largo
- Clinical Research Center, Fundación Valle del Lili, Cali, Colombia
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Xiao Y, Wang J, Yang K, Jiang M, Luo J, Chen K, Zhang B. Effect of methylprednisolone in reducing severe COVID-19 and mortality in high-risk patients: A retrospective study. SAGE Open Med 2024; 12:20503121241276683. [PMID: 39257516 PMCID: PMC11384515 DOI: 10.1177/20503121241276683] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2024] [Accepted: 07/29/2024] [Indexed: 09/12/2024] Open
Abstract
Introduction The treatment of COVID-19 patients, especially high-risk patients, remains a large challenge. Glucocorticoids have been accepted as effective medicines for severe COVID-19. However, the glucocorticoid usage guidelines do not cover all the indications for high-risk patients. Objective To identify more effective treatments for high-risk patients with COVID-19, this retrospective study analyzed routine epidemiological, clinical, and laboratory data from 33 high-risk patients with COVID-19 in Beijing Gobroad Boren Hospital, Beijing, China, most of whom responded well to treatment. Methods Severe acute respiratory syndrome coronavirus-2 infection was confirmed via real-time reverse transcriptase polymerase chain reaction assays. Outcome measures such as duration of mechanical ventilation, intensive care unit length of stay, and 28-day mortality were analyzed. Patients were divided into two groups: mild to moderate COVID-19 (n = 26) and severe COVID-19 (n = 7). Chest computed tomography images were used to guide methylprednisolone administration or withdrawal. Results Upon intensive care unit admission, 12.1% of patients were mechanically ventilated with an average partial pressure of oxygen/fraction of inspired oxygen(PaO2/FiO2) ratio of 279 ± 146. No coinfections with other endemic viruses were observed. The duration of mechanical ventilation was 16 days (interquartile range: 8-28); the intensive care unit length of stay was 11 (interquartile range: 2-33) days; and the 28-day total mortality was 3.0%. Conclusion Multivariate regression analysis revealed that low-dose, timely methylprednisolone administration was associated with a lower severe COVID-19 rate and mortality in high-risk patients. For high-risk patients, once there are ground-glass opacities (GGO) in the computed tomography image, continuous and low-dose methylprednisolone administration promotes inflammation remission and protects them from severe COVID-19 or mortality.
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Affiliation(s)
- Yan Xiao
- Respiratory Infection and Critical Disease Diagnosis and Treatment, Beijing Gobroad Boren Hospital, Beijing, China
| | - Jinwei Wang
- Respiratory Infection and Critical Disease Diagnosis and Treatment, Beijing Gobroad Boren Hospital, Beijing, China
| | - Kai Yang
- Respiratory Infection and Critical Disease Diagnosis and Treatment, Beijing Gobroad Boren Hospital, Beijing, China
| | - Meiling Jiang
- Respiratory Infection and Critical Disease Diagnosis and Treatment, Beijing Gobroad Boren Hospital, Beijing, China
| | - Jialin Luo
- Respiratory Infection and Critical Disease Diagnosis and Treatment, Beijing Gobroad Boren Hospital, Beijing, China
| | - Kun Chen
- Respiratory Infection and Critical Disease Diagnosis and Treatment, Beijing Gobroad Boren Hospital, Beijing, China
| | - Bo Zhang
- Respiratory Infection and Critical Disease Diagnosis and Treatment, Beijing Gobroad Boren Hospital, Beijing, China
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Paik JM, Shah D, Eberly K, Golabi P, Henry L, Younossi ZM. Changes in mortality due to Chronic Liver Diseases (CLD) during the COVID-19 pandemic: Data from the United States' National Vital Statistics System. PLoS One 2024; 19:e0289202. [PMID: 39226267 PMCID: PMC11371215 DOI: 10.1371/journal.pone.0289202] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/20/2023] [Accepted: 07/13/2023] [Indexed: 09/05/2024] Open
Abstract
INTRODUCTION We assessed chronic liver disease (CLD)-related mortality in the U.S. using death data (2011-2021) obtained from National Vital Statistics System (NVSS). The average annual percentage change (AAPC) from the models selected by Joinpoint regression analysis over the pre-pandemic (2011-2019) and the 2019-2021 were reported because non-linear trend in death rates were observed over the 2011-2021. Liver-specific death was defined as an underlying cause of death and Chronic liver disease (CLD)-related death was defined as any cause of death. During the pre-pandemic, age-standardized HCC- and cirrhosis-specific death rates were annually increased by AAPC = +1.18% (95% confidence interval, 0.34% to 2.03%) and AAPC = +1.95% (1.56% to 2.35%). In contrast, during the 2019-2021, the AAPC in age-standardized cirrhosis-specific death rate (per 100,000) accelerated by up to AAPC +11.25% (15.23 in 2019 to 18.86 in 2021) whereas that in age-standardized HCC-specific death rate slowed to -0.39 (-1.32% to 0.54%) (3.86 in 2019 to 3.84 in 2021). Compared to HCC-specific deaths, cirrhosis-specific deaths were more likely to be non-Hispanic white (72.4% vs. 62.0%) and non-Hispanic American Indian and Alaska native (AIAN) (2.2% vs. 1.1%) and have NAFLD (45.3% vs. 12.5%) and ALD (27.6% vs. 22.0%). During the 2019-2021, the age-standardized HCV- and HBV-related death rate stabilized, whereas the age-standardized NAFLD- and ALD-related deaths rate increased to 20.16 in 2021 (AAPC = +12.13% [7.76% to 16.68%]) and to 14.95 in 2021 (AAPC = +18.30% [13.76% to 23.03%]), which were in contrast to much smaller incremental increases during the pre-pandemic (AAPC = +1.82% [1.29% to 2.35%] and AAPC = +4.54% [3.97% to 5.11%]), respectively). The most pronounced rise in the age-standardized NAFLD-related death rates during the pandemic was observed among AIAN (AAPC = +25.38%), followed by non-Hispanic White female (AAPC = +14.28%), whereas the age-standardized ALD-related death rates during the pandemic were highest among AIAN (AAPC = +40.65%), followed by non-Hispanic Black female (AAPC = +26.79%). CONCLUSIONS COVID-19 pandemic had a major negative impact on cirrhosis-specific and CLD-related mortality in the U.S. with significant racial and gender disparities.
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Affiliation(s)
- James M. Paik
- Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, United States of America
- Center for Liver Disease, Department of Medicine, Inova Fairfax Medical Campus, Falls Church, VA, United States of America
| | - Dipam Shah
- Center for Liver Disease, Department of Medicine, Inova Fairfax Medical Campus, Falls Church, VA, United States of America
| | - Katherine Eberly
- Center for Liver Disease, Department of Medicine, Inova Fairfax Medical Campus, Falls Church, VA, United States of America
| | - Pegah Golabi
- Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, United States of America
- Center for Liver Disease, Department of Medicine, Inova Fairfax Medical Campus, Falls Church, VA, United States of America
| | - Linda Henry
- Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, United States of America
- Center for Liver Disease, Department of Medicine, Inova Fairfax Medical Campus, Falls Church, VA, United States of America
- Center for Outcomes Research, Washington DC, United States of America
| | - Zobair M. Younossi
- Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, United States of America
- Center for Liver Disease, Department of Medicine, Inova Fairfax Medical Campus, Falls Church, VA, United States of America
- Inova Medicine, Inova Health System, Falls Church, VA, United States of America
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Stone M, Spencer BR, Warden DE, Fink RV, Saa P, Leddy J, Mulach-Vannoy J, Townsend R, Krysztof D, Hughes AN, Di Germanio C, Kessler DA, Kleinman S, Busch MP, Norris PJ. Patient and Immunological Factors Associated With Delayed Clearance of Mucosal Severe Acute Respiratory Syndrome Coronavirus 2 RNA and Symptom Persistence. J Infect Dis 2024; 230:357-362. [PMID: 38470857 PMCID: PMC11326823 DOI: 10.1093/infdis/jiae132] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/01/2023] [Revised: 03/01/2024] [Accepted: 03/08/2024] [Indexed: 03/14/2024] Open
Abstract
Serial blood and mucosal samples were characterized for 102 participants enrolled a median of 7.0 days after coronavirus disease 2019 diagnosis. Mucosal RNA was detectable for a median of 31.5 (95% confidence interval [CI], 20.5-63.5) days, with persistence ≥1 month associated with obesity (body mass index [BMI] ≥30 kg/m2; odds ratio [OR], 3.9 [95% CI, 1.2-13.8]) but not age, sex, or chronic conditions. Fifteen participants had likely reinfection; lower serum anti-spike IgG levels were associated with reinfection risk. Nearly half of participants (47%) reported symptoms lasting ≥2-3 months; persistence ≥3 months was associated with BMI ≥30 kg/m2 (OR, 4.2 [95% CI, 1.1-12.8]) and peak anti-spike and anti-nucleocapsid antibody levels.
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Affiliation(s)
- Mars Stone
- Vitalant Research Institute, San Francisco, California
- Department of Laboratory Medicine, University of California, San Francisco
| | | | | | | | - Paula Saa
- Scientific Affairs, American Red Cross
| | | | | | | | | | | | - Clara Di Germanio
- Vitalant Research Institute, San Francisco, California
- Department of Laboratory Medicine, University of California, San Francisco
| | | | - Steven Kleinman
- Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada
| | - Michael P Busch
- Vitalant Research Institute, San Francisco, California
- Department of Laboratory Medicine, University of California, San Francisco
| | - Philip J Norris
- Vitalant Research Institute, San Francisco, California
- Department of Laboratory Medicine, University of California, San Francisco
- Department of Medicine, University of California, San Francisco
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Kanat BB, Avci GU, Bayramlar OF, Suzan V, Can G, Balkan II, Borekci S, Korkmazer B, Dikmen Y, Aygun G, Erdincler DS, Yavuzer H, Doventas A. Predictors of 2-year mortality in geriatric patients hospitalized with COVID-19 in Türkiye: a retrospective cohort study. Biomark Med 2024; 18:555-565. [PMID: 39140394 PMCID: PMC11364071 DOI: 10.1080/17520363.2024.2352416] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/20/2023] [Accepted: 04/22/2024] [Indexed: 08/15/2024] Open
Abstract
Aim: To reveal factors affecting 2-year mortality in geriatric patients hospitalized with COVID-19.Methods: Demographic characteristics, clinical and laboratory data, thorax computed tomography (CT) images, second-year survival status, and causes of death were analyzed.Results: The 2-year post-discharge mortality rate of 605 patients was 21.9%. Mean age of patients in the deceased group was 76.8 ± 8.1 years, which was shorter than the life expectancy at birth in Türkiye. Older age (≥85), delirium, some co-morbidities, and atypical thorax CT involvement were associated with a significant increase in 2-year mortality (p < 0.05).Conclusion: This is the first study to evaluate factors associated with 2-year mortality in older COVID-19 patients. Identifying risk factors for long-term mortality in geriatric COVID-19 patients is important.
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Affiliation(s)
- Bahar Bektan Kanat
- Division of Geriatric Medicine, Department of Internal Medicine, Cerrahpasa Medical Faculty, Istanbul University, Cerrahpasa, Istanbul, Turkey
| | - Gulru Ulugerger Avci
- Division of Geriatric Medicine, Department of Internal Medicine, Cerrahpasa Medical Faculty, Istanbul University, Cerrahpasa, Istanbul, Turkey
| | - Osman Faruk Bayramlar
- Bakırkoy District Health Directorate, Turkish Ministry of Health – Istanbul Health Directorate, Istanbul, Turkey
| | - Veysel Suzan
- Division of Geriatric Medicine, Department of Internal Medicine, Cerrahpasa Medical Faculty, Istanbul University, Cerrahpasa, Istanbul, Turkey
| | - Gunay Can
- Department of Public Health, Cerrahpasa Medical Faculty, İstanbul University, Cerrahpaşa, İstanbul, Turkey
| | - Ilker Inanc Balkan
- Department of Infectious Diseases, Cerrahpasa Medical Faculty, İstanbul University, Cerrahpaşa, İstanbul, Turkey
| | - Sermin Borekci
- Department of Pulmonary Diseases, Cerrahpasa Medical Faculty, İstanbul University, Cerrahpaşa, İstanbul, Turkey
| | - Bora Korkmazer
- Department of Radiology, Cerrahpasa Medical Faculty, İstanbul University, Cerrahpaşa, İstanbul, Turkey
| | - Yalim Dikmen
- Department of Anesthesiology & Reanimation, Cerrahpasa Medical Faculty, İstanbul University, Cerrahpaşa, İstanbul, Turkey
| | - Gokhan Aygun
- Department of Medical Microbiology, Cerrahpasa Medical Faculty, İstanbul University, Cerrahpaşa, İstanbul, Turkey
| | - Deniz Suna Erdincler
- Division of Geriatric Medicine, Department of Internal Medicine, Cerrahpasa Medical Faculty, Istanbul University, Cerrahpasa, Istanbul, Turkey
| | - Hakan Yavuzer
- Division of Geriatric Medicine, Department of Internal Medicine, Cerrahpasa Medical Faculty, Istanbul University, Cerrahpasa, Istanbul, Turkey
| | - Alper Doventas
- Division of Geriatric Medicine, Department of Internal Medicine, Cerrahpasa Medical Faculty, Istanbul University, Cerrahpasa, Istanbul, Turkey
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Zhou J, Zhang H, Chen H, Zhang G, Mao J, Zhang T, Tang Y, Yan W, Li C, Ding Y, Jin Q. Pharmacokinetics and safety of GST-HG171, a novel 3CL protease inhibitor, in Chinese subjects with impaired and normal liver function. Antimicrob Agents Chemother 2024; 68:e0053924. [PMID: 38990016 PMCID: PMC11304707 DOI: 10.1128/aac.00539-24] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/17/2024] [Accepted: 06/02/2024] [Indexed: 07/12/2024] Open
Abstract
GST-HG171 is a potent, broad-spectrum, orally bioavailable small-molecule 3C-like (3CL) protease inhibitor that was recently approved for treating mild to moderate coronavirus disease 2019 patients in China. Since cytochrome P450 (CYP) enzymes, primarily CYP3A, are the main metabolic enzymes of GST-HG171, hepatic impairment may affect its pharmacokinetic (PK) profile. Aiming to guide clinical dosing for patients with hepatic impairment, this study, using a non-randomized, open-label, single-dose design, assessed the impact of hepatic impairment on the PK, safety, and tolerability of GST-HG171. Patients with mild and moderate hepatic impairment along with healthy subjects were enrolled (n = 8 each), receiving a single oral dose of 150 mg GST-HG171, with concurrent administration of 100 mg ritonavir to sustain CYP3A inhibition before and after GST-HG171 administration (-12, 0, 12, and 24 hours). Compared to subjects with normal hepatic function, the geometric least-squares mean ratios (90% confidence intervals) for GST-HG171's maximum plasma concentration (Cmax), area under the concentration-time curve up to the last quantifiable time (AUC0-t), and area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) in subjects with mild hepatic impairment were 1.14 (0.99, 1.31), 1.07 (0.88, 1.30), and 1.07 (0.88, 1.29), respectively. For moderate hepatic impairment, the ratios were 0.87 (0.70, 1.07), 0.82 (0.61, 1.10), and 0.82 (0.61, 1.10), respectively. Hepatic impairment did not significantly alter GST-HG171's peak time (Tmax) and elimination half-life (T1/2). GST-HG171 exhibited good safety and tolerability in the study. Taken together, mild to moderate hepatic impairment minimally impacted GST-HG171 exposure, suggesting no need to adjust GST-HG171 dosage for patients with mild to moderate hepatic impairment in the clinic.Clinical TrialsRegistered at ClinicalTrials.gov (NCT06106113).
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Affiliation(s)
- Jing Zhou
- Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China
| | - Hong Zhang
- Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China
| | - Hong Chen
- Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China
| | - George Zhang
- Fujian Akeylink Biotechnology Co., Ltd., Fuzhou, Fujian, China
| | - John Mao
- Fujian Akeylink Biotechnology Co., Ltd., Fuzhou, Fujian, China
| | - Tianxiang Zhang
- Fujian Akeylink Biotechnology Co., Ltd., Fuzhou, Fujian, China
| | - Yanan Tang
- Fujian Akeylink Biotechnology Co., Ltd., Fuzhou, Fujian, China
| | - Wenhao Yan
- Fujian Akeylink Biotechnology Co., Ltd., Fuzhou, Fujian, China
| | - Chuanjing Li
- Fujian Akeylink Biotechnology Co., Ltd., Fuzhou, Fujian, China
| | - Yanhua Ding
- Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China
| | - Qinglong Jin
- Department of Hepatology, The First Hospital of Jilin University, Jilin, China
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Peer A, Perschinka F, Lehner G, Mayerhöfer T, Mair P, Kilo J, Breitkopf R, Fries D, Joannidis M. Outcome of COVID-19 patients treated with VV-ECMO in Tyrol during the pandemic. Wien Klin Wochenschr 2024; 136:465-471. [PMID: 37947878 PMCID: PMC11327186 DOI: 10.1007/s00508-023-02301-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/29/2023] [Accepted: 10/13/2023] [Indexed: 11/12/2023]
Abstract
INTRODUCTION A small percentage of patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV‑2) showed severe respiratory deterioration requiring treatment with extracorporeal membrane oxygenation (ECMO). During the pandemic surges availability of ECMO devices was limited and resources had to be used wisely. The aim of this analysis was to determine the incidence and outcome of venovenous (VV) ECMO patients in Tyrol, when criteria based on the Extracorporeal Life Support Organization (ELSO) guidelines for VV-ECMO initiation were established. METHODS This is a secondary analysis of the Tyrol-CoV-ICU-Reg, which includes all patients admitted to an intensive care unit (ICU) during the coronavirus disease 2019 (COVID-19) pandemic in Tyrol. Of the 13 participating departments, VV-ECMO was performed at 4 units at the University Hospital Innsbruck. RESULTS Overall, 37 (3.4%) of 1101 patients were treated with VV-ECMO during their ICU stay. The hospital mortality rate was approximately 40% (n = 15). Multiorgan failure due to sepsis was the most common cause of death. No significant difference in survival rates between newly initiated and experienced centers was observed. The median survival time of nonsurvivors was 27 days (interquartile range, IQR: 22-36 days) after initiation of VV-ECMO. Acute kidney injury meeting the Kidney Disease: Improving Global Outcomes (KDIGO) criteria occurred in 48.6%. Renal replacement therapy (RRT) was initiated in 12 (32.4%) patients after a median of 18 days (IQR: 1-26 days) after VV-ECMO start. The median length of ICU and hospital stays were 38 days (IQR: 30-55 days) and 50 days (IQR: 37-83 days), respectively. DISCUSSION Despite a rapidly increased demand and the resulting requirement to initiate an additional ECMO center, we could demonstrate that a structured approach with interdisciplinary collaboration resulted in favorable survival rates similar to multinational reports.
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Affiliation(s)
- Andreas Peer
- Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria
| | - Fabian Perschinka
- Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria
| | - Georg Lehner
- Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria
| | - Timo Mayerhöfer
- Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria
| | - Peter Mair
- Department of Anaesthesiology and Intensive Care Medicine, Medical University Innsbruck, Innsbruck, Austria
| | - Juliane Kilo
- Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria
| | - Robert Breitkopf
- Department of Anaesthesiology and Intensive Care Medicine, Medical University Innsbruck, Innsbruck, Austria
| | - Dietmar Fries
- Department of Anaesthesiology and Intensive Care Medicine, Medical University Innsbruck, Innsbruck, Austria
| | - Michael Joannidis
- Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.
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Chen X, Zhu Y, Shen L, Zhou D, Feng N, Tong Q. Efficacy and Safety of Nirmatrelvir/Ritonavir in Severe Hospitalized Patients with COVID-19 and in Patients at High Risk for Progression to Critical Illness: A Real-World Study. J Intensive Care Med 2024; 39:742-750. [PMID: 38356292 DOI: 10.1177/08850666241228841] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/16/2024]
Abstract
Background: Nirmatrelvir/Ritonavir is an orally administered anti-SARS-Cov-2 drug used in mild-to-moderate COVID-19 patients. Our retrospective cohort study aims to evaluate the efficacy and safety of Nirmatrelvir/Ritonavir in severe hospitalized patients with Omicron infection, as well as in patients at high risk for progression to critical illness in real-world settings. Methods: A total of 350 patients received Nirmatrelvir/Ritonavir while 350 matched controls did not. Patients with confirmed COVID-19 were administered Nirmatrelvir 300 mg and Ritonavir 100 mg orally twice a day for 5 days, with the medication initiated on the first day after admission. The primary endpoint of the study was a composite outcome of hospitalization or death from any cause within 28 days. Secondary endpoints included the occurrence of adverse events and the evaluation of serum levels of IL-6 and viral load. Results: We documented the mortality risk from any cause within 28 days, viral load, serum IL-6 levels, and adverse events. Nirmatrelvir/Ritonavir reduced the 28-day risk of all-cause mortality by 86% (P = .011, hazard ratio (HR) = 0.14, 95% confidence interval (CI) = 0.03, 0.64). At baseline, the serum level of IL-6 was significantly higher in the antiviral treatment group compared to the control group (P < .001), but no significant difference (P = .990) was found between the two groups at discharge. In CKD patients undergoing hemodialysis, no significant worsening of renal function was observed in the Nirmatrelvir/Ritonavir treatment group compared to the control group. Conclusion: Nirmatrelvir/Ritonavir may reduce the 28-day risk of all-cause mortality in critically ill patients with COVID-19 and in patients at high risk for critical disease progression.
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Affiliation(s)
- Xiaohua Chen
- Department of Infectious Diseases, Shanghai Sixth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Ying Zhu
- Department of Pulmonary and Critical Care Medicine, 8th Medical Center of Chinese PLA General Hospital General Hospital, Beijing, China
- Department of Pulmonary and Critical Care Medicine, 7th Medical Center of Chinese PLA General Hospital, Beijing, China
| | - Leer Shen
- Department of Infectious Diseases, Shanghai Sixth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Dan Zhou
- Shanghai Key Laboratory of Medical Epigenetics, Laboratory of Cancer Epigenetics, Center for Medical Research and Innovation, Shanghai Pudong Hospital, Institutes of Biomedical Sciences, Medical College of Fudan University, Chinese Academy of Medical Sciences (RU069), Shanghai, China
| | - Nannan Feng
- School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Qiang Tong
- Department of Rheumatology & Immunology, Shanghai Sixth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
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Mahmoud A, Romanato M, Squartini G, Ruggiero A, Spigarelli F, Morgantini A, De Tanti A, Spagnuolo C, Sawacha Z. Clinical gait analysis reveals altered walking patterns in critical Covid 19 survivors. Clin Biomech (Bristol, Avon) 2024; 118:106318. [PMID: 39116645 DOI: 10.1016/j.clinbiomech.2024.106318] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/11/2024] [Revised: 07/09/2024] [Accepted: 07/30/2024] [Indexed: 08/10/2024]
Abstract
BACKGROUND Covid-19 has dramatically increased the number of admissions in intensive care units due to respiratory complications. In some cases, the arousal of neurological impairments, such as peripheral neuropathies, have been revealed. The purpose of this research was to characterize the gait pattern and muscle activity changes in Covid-19 survivors compared to physiological gait. METHODS Twelve post-Covid-19 participants admitted to intensive care units and twelve non-disabled controls were considered. Kinematics, kinetics and surface electromyographic data were collected for each participant during walking. Post Covid-19 participants were further divided into two sub-groups, according to the number of days spent in the intensive care units. Lower limb joint angles, moments and powers were extracted as well as the muscle activity of four muscles bilaterally, the spatial, temporal and spatiotemporal parameters of gait and the ground reaction forces. The extracted variables were compared through OneWay-ANOVA or Kruskal-Wallis tests where appropriate (p < 0.05). FINDINGS Overall, the considered parameters revealed statistically significant reduction in gait speed, cadence, range of motion in the sagittal plane, anteroposterior and vertical ground reaction forces between pathological and control participants. Larger alterations of the gait patterns were highlighted in the post-Covid-19 group hospitalized in intensive care units longer than 35 days, where a reduced muscle activity was observed on all the analyzed muscles. INTERPRETATION Results suggested that the severity of gait impairments in post-Covid-19 participants might be correlated with intensive care units-bedding period. Gait biomechanics assessment could be adopted in the clinical decision-making process to improve treatment protocols in post-Covid-19 survivors.
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Affiliation(s)
| | - Marco Romanato
- Department of Information Engineering, University of Padova, Padova, Italy
| | - Giulia Squartini
- Department of Information Engineering, University of Padova, Padova, Italy
| | - Antonio Ruggiero
- Santo Stefano Rehabilitation Institute, KOS Care, Porto Potenza Picena, Macerata, Italy
| | - Francesco Spigarelli
- Santo Stefano Rehabilitation Institute, KOS Care, Porto Potenza Picena, Macerata, Italy
| | - Antonello Morgantini
- Santo Stefano Rehabilitation Institute, KOS Care, Porto Potenza Picena, Macerata, Italy
| | | | - Chiara Spagnuolo
- Santo Stefano Rehabilitation Institute, KOS Care, Porto Potenza Picena, Macerata, Italy
| | - Zimi Sawacha
- Department of Information Engineering, University of Padova, Padova, Italy.
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Livieratos A, Gogos C, Akinosoglou K. SARS-CoV-2 Variants and Clinical Outcomes of Special Populations: A Scoping Review of the Literature. Viruses 2024; 16:1222. [PMID: 39205196 PMCID: PMC11359867 DOI: 10.3390/v16081222] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/07/2024] [Revised: 07/20/2024] [Accepted: 07/29/2024] [Indexed: 09/04/2024] Open
Abstract
The ongoing COVID-19 pandemic has significantly impacted special populations, including immunocompromised individuals, people living with HIV (PLWHIV), pediatric patients, and those with chronic liver disease (CLD). This scoping review aims to map the clinical outcomes of these vulnerable groups when infected with various SARS-CoV-2 variants. The review identifies trends and patterns, noting that early variants, such as Alpha and Delta, are associated with more severe outcomes, including higher hospitalization and mortality rates. In contrast, the Omicron variant, despite its increased transmissibility, tends to cause milder clinical manifestations. The review highlights the necessity for ongoing surveillance and tailored healthcare interventions due to the heterogeneity of patient populations and the evolving nature of the virus. Continuous monitoring and adaptive healthcare strategies are essential to mitigate the impact of COVID-19 on these high-risk groups.
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Affiliation(s)
| | - Charalambos Gogos
- Department of Medicine, University of Patras, 26504 Rio, Greece; (C.G.); (K.A.)
| | - Karolina Akinosoglou
- Department of Medicine, University of Patras, 26504 Rio, Greece; (C.G.); (K.A.)
- Department of Internal Medicine and Infectious Diseases, University General Hospital of Patras, 26504 Rio, Greece
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Fernandes Lira JG, Alves de Olinda R, Correia Basto da Silva G, Leal de Oliveira L, de Alencar Neta RL, Vilar Cardoso N, Adami F, da Silva Paiva L. Sociodemographic Profile and Risk Factors for the Evolution of Patients with COVID-19 in ICUs in Brazil: A Cross-Sectional Study. ScientificWorldJournal 2024; 2024:2927407. [PMID: 39040155 PMCID: PMC11262879 DOI: 10.1155/2024/2927407] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2024] [Revised: 06/24/2024] [Accepted: 07/01/2024] [Indexed: 07/24/2024] Open
Abstract
This is a cross-sectional study, with secondary data from Brazilian hospitals in the state of Paraíba, between January 2021 and January 2022. The evolution of clinical cases configured the dependent variable (cure or death), while the predictive variables were sociodemographic data, risk factors, use of ventilatory support, and vaccination against COVID-19. With the help of R software, the following tests were used: chi-square, Pearson's chi-square, and Fisher's exact adherence. Simple logistic regression models were constructed, and odds ratios (95% CI) were estimated using the LR test and Wald test. 7373 cases were reported, with a mean age of 58.1. Of the reported cases, 63.8% died. The most frequent sociodemographic profile included male people, of mixed race, with less than eight years of schooling. Chronic cardiovascular disease (OR 1.28; 95% CI: 1.13-1.45), diabetes (OR 1.41; 95% CI: 1.24-1.61), lung disease (OR 1.52; 95% CI: 1.11-2.09), and the use of invasive ventilatory support (OR 14.1; 95% CI: 10.56-18.59) were all associated with increased mortality. Nonvaccination was associated with a decreased risk of death (OR 0.74; 95% CI: 0.65-0.84). Male patients, nonwhite, and those with low education were more likely to have a worse clinical outcome. The risk factors studied were related to deaths, and those who did not require ventilatory support were related to cure.
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Affiliation(s)
| | - Ricardo Alves de Olinda
- State University of Paraíba, Baraúnas Street, 351-Universitário, Campina Grande, PB 58429-500, Brazil
| | | | - Luzibênia Leal de Oliveira
- Federal University of Campina Grande, Juvêncio Arruda Avenue, 795-Bodocongó, Campina Grande, PB 58429-600, Brazil
| | | | - Nívea Vilar Cardoso
- Federal University of Campina Grande, Juvêncio Arruda Avenue, 795-Bodocongó, Campina Grande, PB 58429-600, Brazil
| | - Fernando Adami
- ABC Medical School, Lauro Gomes Avenue, 2000-Vila Sacadura Cabral, Santo André, SP 09060-870, Brazil
| | - Laércio da Silva Paiva
- ABC Medical School, Lauro Gomes Avenue, 2000-Vila Sacadura Cabral, Santo André, SP 09060-870, Brazil
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Cannarella R, Marino M, Crafa A, Bagnara V, La Vignera S, Condorelli RA, Calogero AE. Impact of COVID-19 on testicular function: a systematic review and meta-analysis. Endocrine 2024; 85:44-66. [PMID: 38345682 PMCID: PMC11246276 DOI: 10.1007/s12020-024-03705-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/28/2023] [Accepted: 01/17/2024] [Indexed: 07/14/2024]
Abstract
INTRODUCTION Studies investigating the effects of SARS-CoV-2 on male reproductive function are few and heterogeneous, and results are often conflicting. This systematic review and meta-analysis was carried out on studies conducted in men with active or anamnestic SARS-CoV-2 infection to evaluate its consequences on the male sex hormone profile and semen parameters. MATERIALS AND METHOD This meta-analysis follows the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) protocols. PubMed, Scopus, Cochrane, and Embase databases were searched to identify relevant studies. We originally selected 3553 articles. After the eligibility phase, 16 articles met our inclusion criteria encompassing 11 case-control studies and 5 cohort studies (2 prospective and 3 retrospective studies). We performed the quantitative analysis with Comprehensive Meta-Analysis Software. Cochran-Q and heterogeneity (I2) indexes were used to assess statistical heterogeneity. Sensitivity analysis and publication bias tests were also performed. RESULTS Overall, 1250 patients with active or recent (up to 80 days before) COVID-19 infection and 1232 matched healthy controls were included. Sperm concentration, total sperm count, and total motility were significantly lower in patients compared with controls. Patients also showed lower levels of total testosterone and follicle-stimulating hormone, and higher levels of luteinizing hormone, 17β-estradiol, and prolactin compared with healthy controls. None of the included studies found the presence of SARS-CoV-2 mRNA in the semen of infected patients. CONCLUSION The present systematic review and meta-analysis suggests the presence of an association between SARS-CoV-2 infection and primary testicular damage manifested with a picture of altered steroidogenesis and worsening spermatogenesis. The absence of the virus in the seminal fluid indicates a low possibility of sexual transmission of the infection to partners and offspring. However, our findings mostly show short-term follow-up, while few studies have considered the long-term consequences of the viral infection, thus further studies are needed to evaluate the long-term consequences on male reproductive health.
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Affiliation(s)
- Rossella Cannarella
- Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.
- Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.
| | - Marta Marino
- Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy
| | - Andrea Crafa
- Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy
| | - Vincenzo Bagnara
- Pediatric Surgery Unit, Policlinic G.B. Morgagni, Catania, Italy
| | - Sandro La Vignera
- Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy
| | - Rosita A Condorelli
- Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy
| | - Aldo E Calogero
- Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy
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Casarin M, Silva FH, Pontes AFL, Lima BD, Pirih FQ, Muniz FWMG. Association between sequelae of COVID-19 with periodontal disease and obesity: A cross-sectional study. J Periodontol 2024; 95:688-698. [PMID: 37986698 DOI: 10.1002/jper.23-0412] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/10/2023] [Revised: 10/04/2023] [Accepted: 10/30/2023] [Indexed: 11/22/2023]
Abstract
BACKGROUND To assess the sequelae of coronavirus disease 2019 (COVID-19) and associated factors, such as obesity and periodontitis in adults. METHODS The study included 128 individuals aged ≥35 years with a history of a diagnosis of COVID-19 through real-time polymerase chain reaction (RT-PCR), from Pelotas, Brazil. Self-report sequelae from COVID-19 were defined as the primary outcome. A questionnaire containing sociodemographic, medical, behavioral and self-report of sequelae of COVID-19 was applied. A complete periodontal clinical examination was performed. Weight and height were assessed. Uni-, bi- and multivariate analyses were performed using Poisson regression with robust variance. Additional analyses were performed considering obesity as a subgroup. RESULTS When considering the whole sample, no statistically significant associations between sequelae of COVID-19 with periodontitis (prevalence ratio [PR]:1.14;95% confidence interval [95%CI]: 0.80-1.61) and obesity (0.93 [0.68-1.26]) were identified. In the subgroup analysis, considering only individuals with obesity, those diagnosed with generalized periodontitis had 86% higher probability to have sequelae of COVID-19 when compared to individuals with periodontal health or localized periodontitis. However, when only those without obesity were considered, no significant association with periodontal status was detected (0.82 [0.55-1.23). No significant association with periodontal status were observed when the severity of sequelae (no sequelae, 1 sequela, and >1 sequela) were considered (p > 0.05). CONCLUSIONS Individuals diagnosed with obesity and periodontitis have a higher PR of reporting sequelae from COVID-19 compared to individuals with only obesity.
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Affiliation(s)
- Maísa Casarin
- Department of Periodontology, Post Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Pelotas, Brazil
| | | | | | | | - Flavia Q Pirih
- Section of Periodontics, School of Dentistry, University of California, Los Angeles, Los Angeles, USA
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Aggarwal NR, Nordwall J, Braun DL, Chung L, Coslet J, Der T, Eriobu N, Ginde AA, Hayanga AJ, Highbarger H, Holodniy M, Horcajada JP, Jain MK, Kim K, Laverdure S, Lundgren J, Natarajan V, Nguyen HH, Pett SL, Phillips A, Poulakou G, Price DA, Robinson P, Rogers AJ, Sandkovsky U, Shaw-Saliba K, Sturek JM, Trautner BW, Waters M, Reilly C. Viral and Host Factors Are Associated With Mortality in Hospitalized Patients With COVID-19. Clin Infect Dis 2024; 78:1490-1503. [PMID: 38376212 PMCID: PMC11175705 DOI: 10.1093/cid/ciad780] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/26/2023] [Indexed: 02/21/2024] Open
Abstract
BACKGROUND Persistent mortality in adults hospitalized due to acute COVID-19 justifies pursuit of disease mechanisms and potential therapies. The aim was to evaluate which virus and host response factors were associated with mortality risk among participants in Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3) trials. METHODS A secondary analysis of 2625 adults hospitalized for acute SARS-CoV-2 infection randomized to 1 of 5 antiviral products or matched placebo in 114 centers on 4 continents. Uniform, site-level collection of participant baseline clinical variables was performed. Research laboratories assayed baseline upper respiratory swabs for SARS-CoV-2 viral RNA and plasma for anti-SARS-CoV-2 antibodies, SARS-CoV-2 nucleocapsid antigen (viral Ag), and interleukin-6 (IL-6). Associations between factors and time to mortality by 90 days were assessed using univariate and multivariable Cox proportional hazards models. RESULTS Viral Ag ≥4500 ng/L (vs <200 ng/L; adjusted hazard ratio [aHR], 2.07; 1.29-3.34), viral RNA (<35 000 copies/mL [aHR, 2.42; 1.09-5.34], ≥35 000 copies/mL [aHR, 2.84; 1.29-6.28], vs below detection), respiratory support (<4 L O2 [aHR, 1.84; 1.06-3.22]; ≥4 L O2 [aHR, 4.41; 2.63-7.39], or noninvasive ventilation/high-flow nasal cannula [aHR, 11.30; 6.46-19.75] vs no oxygen), renal impairment (aHR, 1.77; 1.29-2.42), and IL-6 >5.8 ng/L (aHR, 2.54 [1.74-3.70] vs ≤5.8 ng/L) were significantly associated with mortality risk in final adjusted analyses. Viral Ag, viral RNA, and IL-6 were not measured in real-time. CONCLUSIONS Baseline virus-specific, clinical, and biological variables are strongly associated with mortality risk within 90 days, revealing potential pathogen and host-response therapeutic targets for acute COVID-19 disease.
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Affiliation(s)
- Neil R Aggarwal
- Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA
| | - Jacquie Nordwall
- Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA
| | - Dominique L Braun
- Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland
| | - Lucy Chung
- CAMRIS International (under contract no. 75N93019D00025 with National Institute of Allergy and Infectious Diseases, Department of Health and Human Services), National Institute of Health, Bethesda, Maryland, USA
| | - Jordan Coslet
- Velocity Clinical Research, Chula Vista, California, USA
| | - Tatyana Der
- Department of General Internal Medicine, Duke University School of Medicine, Durham, North Carolina, USA
| | | | - Adit A Ginde
- Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA
| | - Awori J Hayanga
- Department of Cardiovascular Thoracic Surgery, West Virginia University School of Medicine, Morgantown, West Virginia, USA
| | - Helene Highbarger
- Virus Isolation and Serology Laboratory, Frederick National Laboratory, National Cancer Institute, Frederick, Maryland, USA
| | - Mark Holodniy
- Veterans Affairs Palo Alto Health Care System, Division of Infectious Diseases and Geographic Medicine, Stanford University, Palo Alto, California, USA
| | - Juan P Horcajada
- Department of Infectious Diseases, Hospital del Mar Research Insititute, UPF, Barcelona, Spain
- CIBERINFEC, Instituto de Salud Carlos III, Madrid, Spain
| | - Mamta K Jain
- Division of Infectious Diseases and Geotropical Medicine, UT Southwestern Medical Center and Parkland Health and Hospital System, Dallas, Texas, USA
| | - Kami Kim
- Division of Infectious Disease and International Medicine, Morsani College of Medicine, University of South Florida and Global Emerging Diseases Institute, Tampa General Hospital, Tampa, Florida, USA
| | - Sylvain Laverdure
- Laboratory of Human Retrovirology and Immunoinformatics, Frederick National Laboratory, National Cancer Institute, Frederick, Maryland, USA
| | - Jens Lundgren
- CHIP Center of Excellence for Health, Immunity, and Infections and Department of Infectious Diseases, Righospitalet, University of Copenhagen, Copenhagen, Denmark
| | - Ven Natarajan
- Laboratory of Molecular Cell Biology, Frederick National Laboratory, National Cancer Institute, Frederick, Maryland, USA
| | - Hien H Nguyen
- Division of Infectious Diseases, Veterans Affairs Northern California, University of California, Davis, Sacramento, California, USA
| | - Sarah L Pett
- The Medical Research Council Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, United Kingdom
- Institute for Global Health, University College London, London, United Kingdom
| | - Andrew Phillips
- Institute for Global Health, University College London, London, United Kingdom
| | - Garyphallia Poulakou
- Third Department of Medicine and Laboratory National and Kapodistrian University of Athens Medical School, Athens, Greece
| | - David A Price
- Newcastle Upon Tyne NHUS Hospitals Foundation Trust, Newcastle Upon Tyne, United Kingdom
| | - Philip Robinson
- Infection Prevention and Hospital Epidemiology, Hoag Memorial Hospital Presbyterian, Newport Beach, California, USA
| | - Angela J Rogers
- Division of Pulmonary, Allergy, and Critical Care Medicine, Stanford University, Palo Alto, California, USA
| | - Uriel Sandkovsky
- Division of Infectious Diseases, Baylor University Medical Center, Dallas, Texas, USA
| | - Katy Shaw-Saliba
- National Institute of Allergy and Infectious Diseases/National Institutes of Health, Bethesda, Maryland, USA
| | - Jeffrey M Sturek
- Division of Pulmonary and Critical Care Medicine, Department of Medicine, UVA Health, Charlottesville, Virginia, USA
| | - Barbara W Trautner
- Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine, Houston, Texas, USA
| | - Michael Waters
- Velocity Clinical Research, Chula Vista, California, USA
| | - Cavan Reilly
- Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA
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Learoyd AE, Nicholas J, Douiri A. The complexity of the relationship between ethnicity and COVID-19 outcomes: author's reply. J Clin Epidemiol 2024; 170:111262. [PMID: 38237670 DOI: 10.1016/j.jclinepi.2024.111262] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/20/2023] [Accepted: 01/09/2024] [Indexed: 04/11/2024]
Affiliation(s)
| | - Jennifer Nicholas
- Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK
| | - Abdel Douiri
- School of Life Course and Population Sciences, King College London, London, UK
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Razonable RR. Protecting the vulnerable: addressing the COVID-19 care needs of people with compromised immunity. Front Immunol 2024; 15:1397040. [PMID: 38756784 PMCID: PMC11096526 DOI: 10.3389/fimmu.2024.1397040] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/06/2024] [Accepted: 04/08/2024] [Indexed: 05/18/2024] Open
Abstract
While the general population regained a certain level of normalcy with the end of the global health emergency, the risk of contracting COVID-19 with a severe outcome is still a major concern for people with compromised immunity. This paper reviews the impact of COVID-19 on people with immunocompromised status, identifies the gaps in the current management landscape, and proposes actions to address this unmet need. Observational studies have demonstrated that people with immune dysfunction have a higher risk of COVID-19-related hospitalization and death, despite vaccination, than the general population. More research is needed to define the optimal prevention and treatment strategies that are specific to people with immunocompromised status, including novel vaccination strategies, monoclonal antibodies that provide passive immunity and complement suboptimal vaccination responses, and improved and safer antiviral treatment for COVID-19. Preventive measures beyond vaccination alone are urgently needed to protect this vulnerable population.
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Affiliation(s)
- Raymund R. Razonable
- Division of Public Health, Infectious Diseases and Occupational Medicine, Department of Medicine, Mayo Clinic, Rochester, MN, United States
- William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic, Rochester, MN, United States
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Quercia R, Di Perri G, Pein C, Bodie J, Singh RSP, Hendrick V, Boffito M. Ritonavir: 25 Years' Experience of Concomitant Medication Management. A Narrative Review. Infect Dis Ther 2024; 13:1005-1017. [PMID: 38609668 PMCID: PMC11098990 DOI: 10.1007/s40121-024-00959-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/21/2023] [Accepted: 03/08/2024] [Indexed: 04/14/2024] Open
Abstract
Ritonavir is a potent inhibitor of the cytochrome P450 3A4 enzyme and is commonly used as a pharmacokinetic (PK) enhancer in antiviral therapies because it increases bioavailability of concomitantly administered antivirals. Decades of experience with ritonavir-enhanced HIV therapies and, more recently, COVID-19 therapies demonstrate that boosting doses of ritonavir are well tolerated, with an established safety profile. The mechanisms of PK enhancement by ritonavir result in the potential for drug-drug interactions (DDIs) with several classes of drugs, thus making co-medication management an important consideration with enhanced antiviral therapies. However, rates of DDIs with contraindicated medications are low, suggesting these risks are manageable by infectious disease specialists who have experience with the use of PK enhancers. In this review, we provide an overview of ritonavir's mechanisms of action and describe approaches and resources available to mitigate adverse events and manage concomitant medication in both chronic and short-term settings.
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Affiliation(s)
- Romina Quercia
- Chief Medical Affairs Office, Pfizer Inc, New York City, NY, USA
| | | | - Carolina Pein
- Chief Medical Affairs Office, Pfizer Inc, New York City, NY, USA.
| | - Jennifer Bodie
- Chief Medical Affairs Office, Pfizer Inc, New York City, NY, USA
| | | | | | - Marta Boffito
- Chelsea and Westminster Hospital NHS Foundation Trust, London, UK
- Department of Infectious Diseases, Imperial College London, London, UK
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Yin X, Zhu W, Tang X, Yang G, Zhao X, Zhao K, Jiang L, Li X, Zhao H, Wang X, Yan Y, Xing L, Yu J, Meng X, Zhao H. Phase I/II clinical trial of efficacy and safety of EGCG oxygen nebulization inhalation in the treatment of COVID-19 pneumonia patients with cancer. BMC Cancer 2024; 24:486. [PMID: 38632501 PMCID: PMC11022442 DOI: 10.1186/s12885-024-12228-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/14/2023] [Accepted: 04/05/2024] [Indexed: 04/19/2024] Open
Abstract
BACKGROUND The antiviral drug Nirmatrelvir was found to be a key drug in controlling the progression of pneumonia during the infectious phase of COVID-19. However, there are very few options for effective treatment for cancer patients who have viral pneumonia. Glucocorticoids is one of the effective means to control pneumonia, but there are many adverse events. EGCG is a natural low toxic compound with anti-inflammatory function. Thus, this study was designed to investigate the safety and efficacy of epigallocatechin-3-gallate (EGCG) aerosol to control COVID-19 pneumonia in cancer populations. METHODS The study was designed as a prospective, single-arm, open-label phase I/II trial at Shandong Cancer Hospital and Institute, between January 5, 2023 to March 31,2023 with viral pneumonia on radiographic signs after confirmed novel coronavirus infection. These patients were treated with EGCG nebulization 10 ml three times daily for at least seven days. EGCG concentrations were increased from 1760-8817umol/L to 4 levels with dose escalation following a standard Phase I design of 3-6 patients per level. Any grade adverse event caused by EGCG was considered a dose-limiting toxicity (DLT). The maximum tolerated dose (MTD) is defined as the highest dose with less than one-third of patients experiencing dose limiting toxicity (DLT) due to EGCG. The primary end points were the toxicity of EGCG and CT findings, and the former was graded by Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. The secondary end point was the laboratory parameters before and after treatment. RESULT A total of 60 patients with high risk factors for severe COVID-19 pneumonia (factors such as old age, smoking and combined complications)were included in this phase I-II study. The 54 patients in the final analysis were pathologically confirmed to have tumor burden and completed the whole course of treatment. A patient with bucking at a level of 1760 umol/L and no acute toxicity associated with EGCG has been reported at the second or third dose gradients. At dose escalation to 8817umol/L, Grade 1 adverse events of nausea and stomach discomfort occurred in two patients, which resolved spontaneously within 1 hour. After one week of treatment, CT showed that the incidence of non-progression of pneumonia was 82% (32/39), and the improvement rate of pneumonia was 56.4% (22/39). There was no significant difference in inflammation-related laboratory parameters (white blood cell count, lymphocyte count, IL-6, ferritin, C-reactive protein and lactate dehydrogenase) before and after treatment. CONCLUSION Aerosol inhalation of EGCG is well tolerated, and preliminary investigation in cancer population suggests that EGCG may be effective in COVID-19-induced pneumonia, which can promote the improvement of patients with moderate pneumonia or prevent them from developing into severe pneumonia. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT05758571. Date of registration: 8 February 2023.
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Affiliation(s)
- Xiaoyan Yin
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, 250117, Jinan, Shandong, China
| | - Wanqi Zhu
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, 250117, Jinan, Shandong, China
| | - Xiaoyong Tang
- Department of Medical Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Science, 250117, Jinan, Shandong Province, China
| | - Guangjian Yang
- Department of Medical Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Science, 250117, Jinan, Shandong Province, China
| | - Xianguang Zhao
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, 250117, Jinan, Shandong, China
| | - Kaikai Zhao
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, 250117, Jinan, Shandong, China
| | - Liyang Jiang
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, 250117, Jinan, Shandong, China
| | - Xiaolin Li
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, 250117, Jinan, Shandong, China
| | - Hong Zhao
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, 250117, Jinan, Shandong, China
| | - Xin Wang
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, 250117, Jinan, Shandong, China
| | - Yuanyuan Yan
- Department of Radiology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Science, 250117, Jinan, Shandong Province, China
| | - Ligang Xing
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, 250117, Jinan, Shandong, China
| | - Jinming Yu
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, 250117, Jinan, Shandong, China
| | - Xiangjiao Meng
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, 250117, Jinan, Shandong, China.
| | - Hanxi Zhao
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, 250117, Jinan, Shandong, China.
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Hammond J, Fountaine RJ, Yunis C, Fleishaker D, Almas M, Bao W, Wisemandle W, Baniecki ML, Hendrick VM, Kalfov V, Simón-Campos JA, Pypstra R, Rusnak JM. Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19. N Engl J Med 2024; 390:1186-1195. [PMID: 38598573 PMCID: PMC11156287 DOI: 10.1056/nejmoa2309003] [Citation(s) in RCA: 51] [Impact Index Per Article: 51.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 04/12/2024]
Abstract
BACKGROUND Nirmatrelvir in combination with ritonavir is an antiviral treatment for mild-to-moderate coronavirus disease 2019 (Covid-19). The efficacy of this treatment in patients who are at standard risk for severe Covid-19 or who are fully vaccinated and have at least one risk factor for severe Covid-19 has not been established. METHODS In this phase 2-3 trial, we randomly assigned adults who had confirmed Covid-19 with symptom onset within the past 5 days in a 1:1 ratio to receive nirmatrelvir-ritonavir or placebo every 12 hours for 5 days. Patients who were fully vaccinated against Covid-19 and who had at least one risk factor for severe disease, as well as patients without such risk factors who had never been vaccinated against Covid-19 or had not been vaccinated within the previous year, were eligible for participation. Participants logged the presence and severity of prespecified Covid-19 signs and symptoms daily from day 1 through day 28. The primary end point was the time to sustained alleviation of all targeted Covid-19 signs and symptoms. Covid-19-related hospitalization and death from any cause were also assessed through day 28. RESULTS Among the 1296 participants who underwent randomization and were included in the full analysis population, 1288 received at least one dose of nirmatrelvir-ritonavir (654 participants) or placebo (634 participants) and had at least one postbaseline visit. The median time to sustained alleviation of all targeted signs and symptoms of Covid-19 was 12 days in the nirmatrelvir-ritonavir group and 13 days in the placebo group (P = 0.60). Five participants (0.8%) in the nirmatrelvir-ritonavir group and 10 (1.6%) in the placebo group were hospitalized for Covid-19 or died from any cause (difference, -0.8 percentage points; 95% confidence interval, -2.0 to 0.4). The percentages of participants with adverse events were similar in the two groups (25.8% with nirmatrelvir-ritonavir and 24.1% with placebo). In the nirmatrelvir-ritonavir group, the most commonly reported treatment-related adverse events were dysgeusia (in 5.8% of the participants) and diarrhea (in 2.1%). CONCLUSIONS The time to sustained alleviation of all signs and symptoms of Covid-19 did not differ significantly between participants who received nirmatrelvir-ritonavir and those who received placebo. (Supported by Pfizer; EPIC-SR ClinicalTrials.gov number, NCT05011513.).
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Affiliation(s)
- Jennifer Hammond
- From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.)
| | - Robert J Fountaine
- From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.)
| | - Carla Yunis
- From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.)
| | - Dona Fleishaker
- From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.)
| | - Mary Almas
- From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.)
| | - Weihang Bao
- From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.)
| | - Wayne Wisemandle
- From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.)
| | - Mary Lynn Baniecki
- From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.)
| | - Victoria M Hendrick
- From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.)
| | - Veselin Kalfov
- From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.)
| | - J Abraham Simón-Campos
- From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.)
| | - Rienk Pypstra
- From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.)
| | - James M Rusnak
- From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.)
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Choi DE, Kim DK, Park S, Lee SH, Park O, Kim T, Yeo HJ, Jang JH, Cho WH, Lee SI, On behalf of Korean Intensive Care Study Group. Clinical characteristics and prognosis of patients with COVID-19 on mechanical ventilation undergoing continuous renal replacement therapy. PLoS One 2024; 19:e0297344. [PMID: 38568934 PMCID: PMC10990228 DOI: 10.1371/journal.pone.0297344] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/26/2023] [Accepted: 01/02/2024] [Indexed: 04/05/2024] Open
Abstract
BACKGROUND The coronavirus disease (COVID-19) pandemic has significantly strained global healthcare, particularly in the management of patients requiring mechanical ventilation (MV) and continuous renal replacement therapy (CRRT). This study investigated the characteristics and prognoses of these patients. METHODS This multicenter retrospective cohort study gathered data from patients with COVID-19 across 26 medical centers. Logistic analysis was used to identify the factors associated with CRRT implementation. RESULTS Of the 640 patients with COVID-19 who required MV, 123 (19.2%) underwent CRRT. Compared to the non-CRRT group, the CRRT group was older and exhibited higher sequential organ failure assessment scores. The incidence of hypertension, diabetes, cardiovascular disease, chronic neurological disease, and chronic kidney disease was also higher in the CRRT group. Moreover, the CRRT group had higher intensive care unit (ICU) (75.6% vs. 26.9%, p < 0.001) and in-hospital (79.7% vs. 29.6%, p < 0.001) mortality rates. CRRT implementation was identified as an independent risk factor for both ICU mortality (hazard ratio [HR]:1.833, 95% confidence interval [CI]:1.342-2.505, p < 0.001) and in-hospital mortality (HR: 2.228, 95% CI: 1.648-3.014, p < 0.001). Refractory respiratory failure (n = 99, 19.1%) was the most common cause of death in the non-CRRT death group, and shock with multi-organ failure (n = 50, 40.7%) was the most common cause of death in the CRRT death group. Shock with multi-organ failure and cardiac death were significantly more common in the CRRT death group, compared to non-CRRT death group. CONCLUSION This study indicates that CRRT is associated with higher ICU and in-hospital mortality rates in patients with COVID-19 who require MV. Notably, the primary cause of death in the CRRT group was shock with multi-organ failure, emphasizing the severe clinical course for these patients, while refractory respiratory failure was most common in non-CRRT patients.
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Affiliation(s)
- Dae-Eun Choi
- Department of Nephrology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Republic of Korea
| | - Duk Ki Kim
- Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Republic of Korea
| | - Sunghoon Park
- Department of Pulmonary, Allergy, and Critical Care Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea
| | - Su Hwan Lee
- Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Onyu Park
- College of Nursing, Research Institute of Nursing Science, Pusan National University, Yangsan, Republic of Korea
| | - Taehwa Kim
- Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Busan, Republic of Korea
| | - Hye Ju Yeo
- Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Busan, Republic of Korea
| | - Jin Ho Jang
- Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Busan, Republic of Korea
| | - Woo Hyun Cho
- Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Busan, Republic of Korea
| | - Song I. Lee
- Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Republic of Korea
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50
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Meng L, Harris L, Shaw L, Lymon H, Reses H, Bell J, Lu PJ, Gibbs-Scharf L, Chorba T. Social and demographic factors associated with receipt of a COVID-19 vaccine initial booster dose and with interval between primary series completion and initial booster dose uptake among persons aged ≥ 12 years, United States, August 2021-October 2022. Vaccine 2024; 42:2122-2126. [PMID: 38453621 PMCID: PMC11187615 DOI: 10.1016/j.vaccine.2024.02.089] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/29/2023] [Revised: 02/28/2024] [Accepted: 02/29/2024] [Indexed: 03/09/2024]
Abstract
COVID-19 booster dose vaccination has been crucial in ensuring protection against COVID-19 including recently predominant Omicron variants. Because vaccines against newer SARS-CoV- 2 variants are likely to be recommended in future, it will be valuable to understand past booster dose uptake among different demographic groups. Using U.S. vaccination data, this study examined intervals between primary series completion and receipt of first booster dose (monovalent or bivalent) during August 2021 - October 2022 among persons ≥12 years of age who had completed a COVID-19 vaccine primary series by October 2021. Sub-populations who were late booster recipients (received a booster dose ≥12 months after the primary series) or received no booster dose included persons <35 years old, Johnson & Johnson/Janssen vaccine primary dose recipients, persons in certain racial and ethnic groups, and persons living in rural and more socially vulnerable areas, and in the South region of the United States; these groups may benefit the most from public health outreach efforts to achieve timely COVID-19 vaccination completion in future.
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Affiliation(s)
- Lu Meng
- CDC COVID-19 Response Team, USA; Division of Health Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, 1600 Clifton Rd NE, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA.
| | - LaTreace Harris
- CDC COVID-19 Response Team, USA; Immunization Services Division, National Center for Immunization and Respiratory Diseases, 1600 Clifton Rd NE, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA
| | - Lauren Shaw
- CDC COVID-19 Response Team, USA; Immunization Services Division, National Center for Immunization and Respiratory Diseases, 1600 Clifton Rd NE, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA
| | - Hoody Lymon
- Division of Health Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, 1600 Clifton Rd NE, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA
| | - Hannah Reses
- Division of Health Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, 1600 Clifton Rd NE, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA
| | - Jeneita Bell
- Division of Health Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, 1600 Clifton Rd NE, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA
| | - Peng-Jun Lu
- Immunization Services Division, National Center for Immunization and Respiratory Diseases, 1600 Clifton Rd NE, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA
| | - Lynn Gibbs-Scharf
- CDC COVID-19 Response Team, USA; Immunization Services Division, National Center for Immunization and Respiratory Diseases, 1600 Clifton Rd NE, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA
| | - Terence Chorba
- CDC COVID-19 Response Team, USA; Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, 1600 Clifton Rd NE, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA.
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