Clinical question: Does the use of remdesivir therapy in symptomatic, non-hospitalized, COVID-19 patients reduce disease progression and hospitalization?
Background: Remdesivir improves morbidity and mortality in hospitalized patients with moderate to severe COVID-19 infection; however, data regarding remdesivir use in non-hospitalized, high-risk, infected patients has been lacking.
Study design: Randomized, double-blind, placebo-controlled
Setting: U.S., Spain, Denmark, and the UK–infusion centers, skilled-nursing facilities, and at home
Synopsis: Unvaccinated patients 12 years or older with at least one risk factor for severe COVID-19 or those older than 60 regardless of risk factor(s) were enrolled at 64 sites worldwide. Patients had at least one symptom of COVID infection for seven days by enrollment. 562 patients underwent 1:1 randomization to receive either remdesivir or placebo infusions. The remdesivir group received a three-day course of infusion at 200 mg on day one and then 100 mg on days two and three. The primary efficacy endpoint was a composite of hospitalization related to infection or death from any cause by day 28. Patients who received remdesivir had an 87% lower risk of COVID-19-related medical visits or all-cause death. Notably, the effectiveness of remdesivir in non-hospitalized patients with COVID-19 was comparable to monoclonal antibody treatment, which has less widespread availability. Study limitations include a low number of patients with liver or kidney disease, lack of racial diversity with greater than 79% white patients in each arm, and the exclusion of vaccinated patients.
Bottom line: High-risk, non-hospitalized patients with COVID-19 treated with remdesivir had a significantly lower progression to hospitalization and death at 28 days.
Citation: Gottlieb RL, et al. Early remdesivir to prevent progression to severe COVID-19 in outpatients. N Engl J Med. 2022;386(4):305-315. doi: 10.1056/NEJMoa2116846.
Dr. Taghvaei is a hospitalist at Denver Health, Denver, and an assistant professor in the division of internal medicine, at the University of Colorado School of Medicine.