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. 2020 Oct 5;54(1):27–36. doi: 10.1016/j.jmii.2020.09.002

Table 2.

Published studies of remdesivir treatment for COVID-19 as of August 2020.


Wang et al.30
Beigel et al.26
Grein et al.28
Goldman et al.27
Spinner et al.70
Enrolled Cases N = 237 N = 1603 N = 61 (53 were analyzed) N = 397 N = 584
Asian ratio 100% (all Chinese) 4.9% 16.7% 11.47% 17.98%
Case definition RT-PCR positive for SARS-CoV-2, had pneumonia, SpO2 ≤ 94% or a ratio of arterial oxygen partial pressure to fractional inspired oxygen ≤ 300 mmHg, and were within 12 days of symptom onset Laboratory-confirmed SARS-CoV-2 infection, with lower respiratory tract involvement RT-PCR positive for SARS-CoV-2, SpO2 ≤ 94% or a need for oxygen support RT-PCR positive for SARS-CoV-2, SpO2 ≤ 94% or a need for oxygen support, and radiologic evidence of pneumonia RT-PCR positive for SARS-CoV-2 within 4 days of randomization and moderate COVID-19 pneumonia (defined as any radiographic evidence of pulmonary infiltrates and oxygen saturation >94% on room air)
Trial design Double-blind, randomized, placebo-controlled multicenter trial Double-blind, randomized, placebo-controlled multicenter trial Compassionate use Open-label, randomized, phase 3 trial, multicenter trial (SIMPLE trial) Randomized, open-label, phase 3, multicenter trial
Countries/sites Ten hospitals in Hubei, China. Sixty trial sites globally Twenty-two cases in United States, 22 cases in Europe or Canada, and 9 cases in Japan. Fifty-five hospitals in the United States, Italy, Spain, Germany, Hong Kong, Singapore, South Korea, and Taiwan 105 hospitals in the United States, Europe, and Asia
Remdesivir: placebo ratio. 2 : 1 permitted concomitant use of lopinavir–ritonavir, interferon, and corticosteroids 1 : 1 All received remdesivir All received remdesivir (1:1 ratio to receive for 5 or 10 days) Patients were randomized in a 1:1:1 ratio to receive a 10-day course of remdesivir (n = 197), a 5-day course of remdesivir (n = 199), or standard care (n = 200).
Primary endpoint Time to clinical improvement Time to recovery Clinical improvement Clinical improvement Clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7).
Dosage Intravenous remdesivir 200 mg on day 1, followed by 100 mg on days 2–10 in all four trials
Result Hazard ratio 1.23 [95% CI 0.87–1.75]). Rate ratio for recovery, 1.32; 95% CI, 1.12–1.55; P < 0.001)a median recovery time of 11 days (95% CI, 9–12) compared with 15 days (95% CI, 13–19) in those who received placebo 68% of patients had an improvement in oxygen-support class. On day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and 54% in the 10-day group. On day 11, patients in the 5-day remdesivir group had statistically significantly higher odds of a better clinical status distribution than those receiving standard care (odds ratio, 1.65; 95% CI, 1.09–2.48; P = .02). The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18)
Result in Asian patients N/A Rate ratio for recovery is worst in the Asian subgroup [1.20, 95% CI, 0.65–2.22] N/A N/A N/A
Grade 3 adverse events (remdesivir placebo) 18% vs 26% 21.1% vs 27% 23% 27% in 5-day group; 34% in 10-day group 12%, 10%, 12% in 5-day group, 10-day group and standard care. Nausea (10% vs 3%), hypokalemia (6% vs 2%), and headache (5% vs 3%) were more frequent among remdesivir-treated patients compared with standard care.
a

Indicates statistical significance.