Remdesivir Flashcards
ACTT-1
ACTT-1 was a phase 3, multinational, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of remdesivir in hospitalized patients with mild, moderate, or severe Covid-19.3 A total of 1062 eligible patients were randomly assigned in a 1:1 ratio to receive remdesivir or placebo for up to 10 days. The primary efficacy end point was time to recovery through day 29. In the overall population, the median time to recovery was 10 days in the remdesivir group as compared with 15 days in the placebo group (recovery rate ratio, 1.29; 95% confidence interval [CI], 1.12 to 1.49; P<0.001). The predefined key secondary end point of odds of clinical improvement at day 15, based on an eight-category ordinal scale, also significantly favored remdesivir over placebo (odds ratio, 1.54; 95% CI, 1.25 to 1.91). The 29-day mortality was 11% in the remdesivir group, as compared with 15% in the placebo group (hazard ratio, 0.73; 95% CI, 0.52 to 1.03) — a result that left uncertainty about whether remdesivir provides a survival benefit in addition to accelerating time to recovery.
Time to recovery 10 days vs 15 days in placebo.
Benefited group 5 most, receiving oxygen and benefit less that 10 days, steroids more than 10 days.
Solidarity Trial
At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan–Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P=0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P=0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P=0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P=0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration.
