Table 1.
Efficacy of remdesivir in hospitalized patients with COVID-19 in the phase III ACTT-1 trial [26]
Endpoints (ITT population) | REMa
(n = 541) |
PL (n = 521) |
RR/OR/HR (95% CI) |
---|---|---|---|
Median time to recoveryb (days) | 10* | 15 | RR 1.29 (1.12–1.49) |
Clinical status at day 15 (% of pts) | OR 1.5 (1.2–1.9) | ||
1: Not hospitalized and no limitations of activities | 29 | 22 | |
2: Not hospitalized, with limitation of activities, home O2 requirement or both | 22 | 20 | |
3: Hospitalized, not requiring supplemental O2 or ongoing medical care | 3 | 2 | |
4: Hospitalized, not requiring supplemental O2 but requiring ongoing medical care | 7 | 6 | |
5: Hospitalized, requiring supplemental O2 | 11 | 12 | |
6: Hospitalized, requiring NIV or high-flow O2 | 5 | 5 | |
7: Hospitalized, receiving IMV or ECMO | 18 | 23 | |
8: Death | 6 | 11 | |
Median time to clinical improvement (days) | |||
Improvement of 1 point on an 8-point ordinal scale | 7 | 9 | RR 1.23 (1.08–1.41) |
Improvement of 2 points on an 8-point ordinal scale | 11 | 14 | RR 1.29 (1.12–1.48) |
Discharge or NEWS ≤ 2 for 24 h | 8 | 12 | HR 1.27 (1.10–1.46) |
Median duration of initial hospitalization (days) | 12 | 17 | |
Rehospitalization (% of pts) | 5 | 3 | |
Kaplan–Meier estimate of mortality (%) | |||
Day 15 | 7 | 12 | HR 0.55 (0.36–0.83) |
Day 29 | 11 | 15 | HR 0.73 (0.52–1.03) |
ECMO extracorporeal membrane oxygenation, HR hazard ratio, IMV invasive mechanical ventilation, ITT intention-to-treat, NEWS National Early Warning Score, NIV non-invasive ventilation, O2 oxygen, OR odds ratio, PL placebo, pt(s) patient(s), REM remdesivir, RR rate ratio
*p < 0.001 vs PL
aIntravenous infusion of 200 mg on day 1 and 100 mg on subsequent days
bPrimary endpoint, defined as the first day, during the 28 days after enrolment, on which a pt met the criteria for category 1, 2 or 3 on an 8-point ordinal scale