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 |
|
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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. |
Indicates statistical significance.