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Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients
Robert L Gottlieb1, Carlos E Vaca1, Roger Paredes1
1From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).
Background:
Remdesivir improves clinical outcomes in patients hospitalized with moderate-to-severe coronavirus disease 2019 (Covid-19). Whether the use of remdesivir in symptomatic, nonhospitalized patients with Covid-19 who are at high risk for disease progression prevents hospitalization is uncertain.
Methods:
We conducted a randomized, double-blind, placebo-controlled trial involving nonhospitalized patients with Covid-19 who had symptom onset within the previous 7 days and who had at least one risk factor for disease progression (age ≥60 years, obesity, or certain coexisting medical conditions). Patients were randomly assigned to receive intravenous remdesivir (200 mg on day 1 and 100 mg on days 2 and 3) or placebo. The primary efficacy end point was a composite of Covid-19-related hospitalization or death from any cause by day 28. The primary safety end point was any adverse event. A secondary end point was a composite of a Covid-19-related medically attended visit or death from any cause by day 28.
Results:
A total of 562 patients who underwent randomization and received at least one dose of remdesivir or placebo were included in the analyses: 279 patients in the remdesivir group and 283 in the placebo group. The mean age was 50 years, 47.9% of the patients were women, and 41.8% were Hispanic or Latinx. The most common coexisting conditions were diabetes mellitus (61.6%), obesity (55.2%), and hypertension (47.7%). Covid-19-related hospitalization or death from any cause occurred in 2 patients (0.7%) in the remdesivir group and in 15 (5.3%) in the placebo group (hazard ratio, 0.13; 95% confidence interval [CI], 0.03 to 0.59; P = 0.008). A total of 4 of 246 patients (1.6%) in the remdesivir group and 21 of 252 (8.3%) in the placebo group had a Covid-19-related medically attended visit by day 28 (hazard ratio, 0.19; 95% CI, 0.07 to 0.56). No patients had died by day 28. Adverse events occurred in 42.3% of the patients in the remdesivir group and in 46.3% of those in the placebo group.
Conclusions:
Among nonhospitalized patients who were at high risk for Covid-19 progression, a 3-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalization or death than placebo. (Funded by Gilead Sciences; PINETREE ClinicalTrials.gov number, NCT04501952; EudraCT number, 2020-003510-12.).
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