This preliminary report from a double-blind, randomized, placebo-controlled study found remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.
- Enrollment for ACTT-1 began on February 21, 2020, and ended on April 19, 2020 and 73 trial sites/subsites: United States (45 sites), Denmark (8), the United Kingdom (5), Greece (4), Germany (3), Korea (2), Mexico (2), Spain (2), Japan (1), and Singapore (1)
- Participants had to meet one of the following criteria suggestive of lower respiratory tract infection at the time of enrollment: radiographic infiltrates by imaging study, peripheral oxygen saturation (SpO2) ≤94% on room air, or requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Initially had a requirement for RT-PCR positive SAR-CoV-2 test result but this was modified due to limited testing capacity.
- Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days.
- The primary outcome measure was the time to recovery, defined as the first day, during the 28 days after enrollment, on which a patient satisfied categories 1, 2, or 3 on the eight-category ordinal scale.
- Of the 1107 patients who were assessed for eligibility, 1063 underwent randomization; 541 were assigned to the remdesivir group and 522 to the placebo group
- Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 11 days, as compared with 15 days; rate ratio for recovery, 1.32; 95% confidence interval [CI], 1.12 to 1.55; P<0.001; 1059 patients)
- The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.50; 95% CI, 1.18 to 1.91; P=0.001; 844 patients)
- Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04; 1059 patients)
- Safety outcomes analysis did not show statistically significant concerns for the use of remdesivir