CAUTION: The evidence available regarding COVID-19 treatments (even limited to the randomized trial evidence) is very limited and potentially unstable. Much of the available evidence is not published in peer-reviewed final form, and most treatments are currently considered experimental.
Outcome | Sample size (# trials, # participants, # events) | Result without remdesivir | Result with remdesivir | Effect estimate (remdesivir effect) | Certainty of finding (Quality of evidence) | What this means |
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Mortality at 14 days | 2 trials, 1290 participants, 108 events | 102 out of 1,000 (10.2%) | 62 out of 1,000 (6.2%) 95% CI 32 to 92 out of 1,000 (3.2% to 9.2%) | Relative risk 0.65 (95% CI 0.45 to 0.94) Risk difference -4% (95% CI -7% to -1%) 40 fewer out of 1,000 (95% CI 70 fewer to 10 fewer) | Moderate certainty due to inconsistency | Remdesivir may reduce 14-day mortality, but this finding has not been repeated in a second trial |
Mortality at 28 days | 1 trial, 236 participants, 32 events | 128 out of 1,000 (12.8%) | 139 out of 1,000 (13.9%) 95% CI 47 to 231 out of 1,000 (4.7% to 23.1%) | Risk difference 1.1% (95% CI -8.1% to 10.3%) 11 more out of 1,000 (95% CI 81 fewer to 103 more) | Very low certainty due to risk of bias and very serious imprecision | insufficient evidence to determine effect of remdesivir on 28-day mortality in adults hospitalized with COVID-19 pneumonia |
Mechanical ventilation, ECMO or death at 2 weeks | 2 trials, 1075 participants, 253 events | 289 out of 1,000 (28.9%) | 199 out of 1,000 (19.9%) 95% CI 149 to 249 out of 1,000 (14.9% to 24.9%) | Relative risk 0.69 (95% CI 0.56 to 0.86) Risk difference -9% (95% CI -14% to -4%) 90 fewer out of 1,000 (95% CI 140 fewer to 40 fewer) | Moderate certainty due to risk of bias | Remdesivir may reduce the likelihood of being on a ventilator, ECMO or dead at 2 weeks, but more data needed from the ACTT-1 |
Time to recovery | 1 trial, 1059 participants, 607 events | Median 15 days (95% CI 13 days to 19 days) | Median 11 days (95% CI 9 days to 12 days) | Median difference -4 days Hazard ratio 1.32 (95% CI 1.12 to 1.55) | Moderate certainty due to risk of bias | Remdesivir may reduce time to recovery in adults hospitalized with COVID-19 pneumonia, but more data needed from the ACTT-1 |
Time to clinical improvement | 1 trial, 236 participants | Median 23 days (IQR 15 to 28 days) | Median 21 days (IQR 13 to 28 days) | Median difference -2 days Hazard ratio 1.23 (95% CI 0.87 to 1.75) | Very low certainty due to risk of bias and very serious inconsistency | insufficient evidence to determine effect of remdesivir on time to clinical improvement in adults hospitalized with COVID-19 pneumonia |
Adverse events (any) | 2 trials, 1299 participants | No adverse event (collectively or individually) was significantly increased with remdesivir. (See Summary of Individual Trials for detail.) | Not rated | Remdesivir does not appear to increase the likelihood of adverse events |
ACTT-11 | Lancet 2020 Apr 29 2 | |
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Population | ||
Characteristics | Adults with COVID-19 pneumonia and admitted to hospital | Adults with COVID-19 pneumonia and admitted to hospital |
Observed cohort | 1,063 patients admitted to 73 trial sites in US (45 sites), Denmark (8), UK (5), Greece (4), Germany (3), Korea (2), Mexico (2), Spain (2), Japan (1), and Singapore (1) February 21 to April 19, 2020 | 237 patients admitted to 10 hospitals in Wuhan, Hubei, China February 6 to March 12, 2020 |
Dose | Remdesivir 200 mg IV on day 1 then 100 mg IV once daily on days 2-10 | Remdesivir 200 mg IV on day 1 then 100 mg IV once daily on days 2-10 |
Risk of Bias | Moderate risk of bias | Moderate risk of bias |
Outcomes | ||
Mortality at 14 days | 32/538 (5.9%) vs. 54/521 (10.4%), Kaplan-Meier estimate 7.1% (95% CI 5.0% to 9.9%) vs. 11.9% (9.2% to 15.4%) Observed risk difference -4.4% (95% CI -1.1% to -7.8%), Estimated risk difference -4.8% (Hazard ratio 0.70, 95% CI 0.47 to 1.04) | 15/153 (9.8%) vs. 7/78 (9%) Risk difference 0.8% (95% CI -8.4% to 8.2%) |
Mortality at 28 days | 22/158 (13.9%) vs. 10/78 (12.8%) Risk difference 1.1% (95% CI -8.1% to 10.3%) | |
Mechanical ventilation, ECMO or death at 2 weeks | Mechanical ventilation, ECMO or death at 15 days in 93/434 (21.4%) vs. 127/410 (31.0%) Risk difference -9.5% (95% CI -3.6% to -15.4%) | 19/153 (12.4%) vs. 14/78 (17.9%) Risk difference -5.5% (95% CI -16.4% to 3.8%) |
Time to recovery | Median 11 days (95% CI 9 to 12 days) vs. 15 days (95% CI 13 to 19 days) Median difference -4 days (hazard ratio 1.32, 95% CI 1.12 to 1.55, p <0.001) | |
Time to clinical improvement | Median 21 days (IQR 13 to 28 days) vs. 23 days (IQR 15 to 28 days) Median difference -2 days (hazard ratio 1.23, 95% CI 0.87 to 1.75) | |
Adverse events (any) | Non-serious adverse events in 156/541 (28.8%) vs. 172/522 (33.0%), Serious adverse events in 114/541 (21.1%) vs. 141/522 (27.0%) No adverse event (collectively or individually) was significantly increased with remdesivir | 102/155 (66%) vs. 50/78 (64%) No adverse event (collectively as 'any' or individually) was significantly increased with remdesivir Although drug discontinuation due to adverse events was reported more frequently with remdesivir (18 events, 12%) than placebo (4 events, 5%), 7 of the remdesivir group events (5%) were acute respiratory failure which does not appear likely to be due to remdesivir |