Copyright
©The Author(s) 2021.
World J Meta-Anal. Feb 28, 2021; 9(1): 74-87
Published online Feb 28, 2021. doi: 10.13105/wjma.v9.i1.74
Published online Feb 28, 2021. doi: 10.13105/wjma.v9.i1.74
Table 1 General and baseline characteristics of included studies
Reference | Design | Study population | Total number of participants randomized/ completed | Age, mean ± SD years/median (IQR) | Male gender, % | Coexisting conditions, % | Severity status, % | Drug, dose and duration of interventions | Follow-up duration in d | |
Remdesivir | Comparator | |||||||||
Beigel et al[14] | Double-blind, randomized, placebo-controlled trial | Hospitalized COVID-19 patients with evidence of lower respiratory tract involvement | Total: 1062/1025; Remdesivir: 541/517; Placebo: 521/508 | Remdesivir: 58.6 ± 14.6; Placebo: 59.2 ± 15.4 | Total: 64.4; Remdesivir: 65.1; Placebo: 63.7 | Remdesivir: DM (30.8) HT (50.6); Placebo: DM (30.4); HT (50.9) | Remdesivir: MV or ECMO (24.2); Placebo: MV or ECMO (29.6) | Day 1: 200 mg iv loading dose on day 2-10: 100 mg iv daily | Placebo | 29 |
WHO Solidarity Trial Consortium et al[15] | Open-labeled, randomized controlled Trial | Hospitalized COVID-19 patients | Remdesivir: 2750/2743; SC: 2725/2708 | Remdesivir: NS; SC: NS | Total: 62.9; Remdesivir: 62.2; SC: 63.7 | Remdesivir: DM (25.8); HD (20.8); Asthma (5.1); SC: DM (24.6); HD (20.9); Asthma (5.1) | Remdesivir: Ventilated (9.2); SC: Ventilated (8.6) | Day 1: 200 mg iv loading dose on day 2-10: 100 mg iv daily | SC | 28 |
Spinner et al[20] | Open-labeled, randomized controlled Trial | Hospitalized moderate severity COVID-19 pneumonia patients | Total: 397/393; Remdesivir: 197/193; SC: 200/200 | Remdesivir: 56 (45-66)1; SC: 57 (45-66)1 | Remdesivir: 61; SC: 63 | Remdesivir: DM (44); HD (58); HT (44); Asthma (16); SC: HT (41); Asthma (14); DM (38); HD (54); | Remdesivir: Supplemental oxygen (13); SC: Supplemental oxygen (19) | Day 1: 200 mg iv loading dose on day 2-10: 100 mg iv daily | SC | 28 |
Wang et al[21] | Double-blind, randomized, placebo-controlled trial | Severe COVID-19 with pneumonia | Total: 237/226; Remdesivir: 158/150; Placebo: 79/76 | Test: 66 (57-73)1; Placebo: 64 (53-70)1 | Remdesivir: 56; Placebo: 65 | Remdesivir: DM (25); HT (46); HD (9); Placebo: DM (21); HT (38); HD (3) | Remdesivir: Supplemental oxygen (100); Placebo: Supplemental oxygen (95) | Day 1: 200 mg iv loading dose on day 2-10: 100 mg iv daily | Placebo | 28 |
Table 2 Risk of bias assessment as per the Revised Cochrane risk of bias tool for randomized trials
Domain No. | Risk of bias domains | Beigel et al[14] | WHO Solidarity Trial Consortium et al[15] | Spinner et al[20] | Wang et al[21] |
1 | Risk of bias arising from the randomization process | Low | Low | Low | Low |
2a | Risk of bias due to deviations from the intended interventions (effect of assignment to intervention) | Low | Low | Some concern | Low |
2b | Risk of bias due to deviations from the intended interventions (effect of adhering to intervention) | Low | Low | Low | Low |
3 | Missing outcome data | Low | Low | Low | Low |
4 | Risk of bias in measurement of the outcome | Low | Low | Low | Low |
5 | Risk of bias in selection of the reported result | Low | Low | Low | Low |
-- | Overall risk of bias assessment | Low | Low | Some concerns | Low |
Table 3 Quality assessment for efficacy and safety parameters as per the GRADE approach
No. of studies (design) | Limitation | Inconsistency | Indirectness | Imprecision | Publication bias | Quality | RR (95%CI) |
Mortality | |||||||
Four (RCT) | No serious limitations | Serious inconsistency (I2 = 59%) | No serious indirectness | No serious imprecision | Asymmetric Funnel plot | Moderate | 0.83 (0.57-1.20) |
Ventilation | |||||||
Four (RCT) | No serious limitations | Serious inconsistency (I2 = 77%) | No serious indirectness | No serious imprecision | Asymmetric Funnel plot | Moderate | 0.69 (0.41-1.18) |
Composite Mortality and ventilation | |||||||
Four (RCT) | No serious limitations | Serious inconsistency (I2 = 78%) | No serious indirectness | No serious imprecision | Asymmetric Funnel plot | Moderate | 0.80 (0.58-1.11) |
Clinical recovery | |||||||
Three (RCT) | No serious limitations | No serious inconsistency | No serious indirectness | No serious imprecision | Asymmetric Funnel plot | Moderate | 1.10 (1.04-1.16) |
Adverse event | |||||||
Three (RCT) | No serious limitations | Serious inconsistency (I2 = 77%) | No serious indirectness | No serious imprecision | Asymmetric Funnel plot | Moderate | 1.05 (0.86-1.27) |
Grade 3 or 4 adverse event | |||||||
Three (RCT) | No serious limitations | No serious inconsistency | No serious indirectness | No serious imprecision | Asymmetric Funnel plot | Moderate | 0.88 (0.79-0.99) |
Serious adverse event | |||||||
Three (RCT) | No serious limitations | No serious inconsistency | No serious indirectness | No serious imprecision | Asymmetric Funnel plot | Moderate | 0.75 (0.63-0.89) |
Table 4 Sensitivity analysis of efficacy and safety outcomes based on the risk of bias assessment and study design
Variable | All studies | Sensitivity analysis(risk of bias assessment) | Sensitivity analysis (study design) | |||
RR (95%CI) | I2 | RR (95%CI) | I2 | RR (95%CI) | I2 | |
Mortality | 0.83 (0.57-1.20) | 59 | 0.83 (0.55-1.26) | 73 | 0.74 (0.38-1.44) | 65 |
Ventilation | 0.69 (0.41-1.18) | 77 | 0.73 (0.42-1.27) | 83 | 0.57 (0.41-0.77) | 00 |
Composite mortality and ventilation | 0.80 (0.58-1.11) | 78 | 0.83 (0.60-1.16) | 84 | 0.69 (0.55-0.86) | 10 |
Clinical recovery | 1.10 (1.04-1.16) | 00 | 1.10 (1.02-1.18) | 00 | 1.10 (1.02-1.18) | 00 |
Adverse event | 1.05 (0.86-1.27) | 77 | 0.94 (0.86-1.02) | 00 | 0.94 (0.86-1.02) | 00 |
Grade 3 or 4 adverse event | 0.89 (0.80-0.99) | 00 | 0.87 (0.71-1.07) | 10 | 0.87 (0.71-1.07) | 10 |
Serious adverse event | 0.75 (0.63-0.90) | 00 | 0.76 (0.64-0.92) | 00 | 0.76 (0.64-0.92) | 00 |
- Citation: Patel TK, Patel PB, Barvaliya M, Vijayalaxmi, Bhalla HL. Efficacy and safety outcomes with remdesivir in COVID-19 patients: A meta-analysis. World J Meta-Anal 2021; 9(1): 74-87
- URL: https://www.wjgnet.com/2308-3840/full/v9/i1/74.htm
- DOI: https://dx.doi.org/10.13105/wjma.v9.i1.74