The aim of this randomised, double-blind, placebo-controlled, multicentre trial was to analyze the effects of Remdesivir in adult patients with severe COVID-19 infection. Patients were randomly assigned in a 2:1 ratio to intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2–10 in single daily infusions) or the same volume of placebo infusions for 10 days. The primary endpoint was time to clinical improvement up to day 28, defined as the time (in days) from randomisation to the point of a decline of two levels on a six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first. Between Feb 6 and March 12 2020, 237 patients were enrolled and randomly assigned to a treatment group (158 to remdesivir and 79 to placebo). Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23 [95% CI 0·87–1·75]). Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95–2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early. The authors concluded that in this study remdesivir was not associated with statistically significant clinical benefits. However, they note that the numerical reduction in time to clinical improvement in those treated earlier may merit further investigation in larger studies.
by Marialuisa Zedde and Francesco Cavallieri