Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients
Robert L Gottlieb, Carlos E Vaca, Roger Paredes, Jorge Mera, Brandon J Webb, Gilberto Perez, Godson Oguchi, Pablo Ryan, Bibi U Nielsen, Michael Brown, Ausberto Hidalgo, Yessica Sachdeva, Shilpi Mittal, Olayemi Osiyemi, Jacek Skarbinski, Kavita Juneja, Robert H Hyland, Anu Osinusi, Shuguang Chen, Gregory Camus, Mazin Abdelghany, Santosh Davies, Nicole Behenna-Renton, Frank Duff, Francisco M Marty, Morgan J Katz, Adit A Ginde, Samuel M Brown, Joshua T Schiffer, Joshua A Hill
New England Journal of Medicine, doi:10.1056/nejmoa2116846
BACKGROUND Remdesivir improves clinical outcomes in patients hospitalized with moderate-tosevere 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-19related 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-19related 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.
Appendix The authors' full names and academic degrees are as follows: Robert L. Gottlieb
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'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...'}]},
{ 'ORCID': 'http://orcid.org/0000-0002-7665-7100',
'authenticated-orcid': False,
'given': 'Joshua A.',
'family': 'Hill',
'sequence': 'additional',
'affiliation': [ { 'name': 'From 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...'}]}],
'member': '150',
'published-online': {'date-parts': [[2021, 12, 22]]},
'container-title': ['New England Journal of Medicine'],
'original-title': [],
'language': 'en',
'link': [ { 'URL': 'http://www.nejm.org/doi/pdf/10.1056/NEJMoa2116846',
'content-type': 'unspecified',
'content-version': 'vor',
'intended-application': 'similarity-checking'}],
'deposited': { 'date-parts': [[2021, 12, 22]],
'date-time': '2021-12-22T22:01:38Z',
'timestamp': 1640210498000},
'score': 1,
'subtitle': [],
'short-title': [],
'issued': {'date-parts': [[2021, 12, 22]]},
'references-count': 25,
'alternative-id': ['10.1056/NEJMoa2116846'],
'URL': 'http://dx.doi.org/10.1056/nejmoa2116846',
'relation': {},
'ISSN': ['0028-4793', '1533-4406'],
'issn-type': [{'value': '0028-4793', 'type': 'print'}, {'value': '1533-4406', 'type': 'electronic'}],
'subject': ['General Medicine'],
'published': {'date-parts': [[2021, 12, 22]]}}
