A study published in the New England Journal of Medicine found that hospitalized COVID-19 patients who received Gilead Sciences' antiviral drug remdesivir recovered a median of four days earlier than those who received a placebo.
Preliminary findings from the double-blind Adaptive COVID-19 Treatment Trial (ACTT-1), sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), showed that the 538 patients randomly assigned to receive remdesivir had a median recovery time of 11 days (95 percent confidence interval [CI], 9 to 12), compared with 15 days (95 percent CI, 13 to 19) in the 521 patients who received a placebo (rate ratio for recovery, 1.32; 95 percent CI, 1.12 to 1.55; P < 0.001).
The patients were enrolled from February 21 to April 19 at 60 study sites and 13 subsites in the United States and Mexico (79.8 percent), Europe (15.3 percent), and Asia (4.9 percent), on the basis of the evolving epidemiology of the pandemic. Patients received either a placebo for 10 days or remdesivir intravenously as a 200-milligram (mg) loading dose followed by 100-mg maintenance doses for the next nine days or until release from the hospital or death. The analysis includes only patients with at least some post-baseline data available.
The most common disease severity score, rated from 1 (not requiring hospitalization) to 8 (dead), was 5 (needing oxygen). In patients with a score of 5, remdesivir was associated with a 47 percent speedier recovery, versus 20 percent in patients with a score of 6 (needing high-flow ventilation), and only 0.05 percent in patients with a score of 7 (needing intubation or extracorporeal membrane oxygenation [oxygen added to the blood outside the body]).
The authors noted that patients requiring supplemental oxygen derived the most benefit from remdesivir, while it did not benefit those requiring more intense treatments. After the NIAID made the results public late last month, the U.S. Food and Drug Administration on May 1 issued an emergency use authorization (EUA) for remdesivir for the treatment of seriously ill COVID-19 patients.
