Remdesivir for 5 or 10 Days in Patients with Severe Covid-19
Open accessAbstract
BACKGROUND: Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19). METHODS: We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale. RESULTS: In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%). CONCLUSIONS: In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.).
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- Authors
- Goldman, J. D., Lye, D. C. B., Hui, D. S., Marks, K. M., Bruno, R., Montejano, R., Spinner, C. D., Galli, M., Ahn, M.-Y., Nahass, R. G., Chen, Y.-S., SenGupta, D., Hyland, R. H., Osinusi, A. O., Cao, H., Blair, C., Wei, X., Gaggar, A., Brainard, D. M., Towner, W. J., Muñoz, J., Mullane, K. M., Marty, F. M., Tashima, K. T., Diaz, G., & Subramanian, A.
- Affiliations
- NewYork–Presbyterian Hospital (US)
- From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) — both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong–Prince of Wales Hospital, Hong Kong (D.S.H.); New York–Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie...
- Corresponding author
- Brainard, Diana M.
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-11-05
- Volume
- 383
- Issue
- 19
- Pages
- 1827-1837
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC7377062
- OpenAlex
- W3032677067
- Cited by
- 1,362
- References
- 24
- Citations by year
- 2026: 21 · 2025: 29 · 2024: 69 · 2023: 140 · 2022: 275 · 2021: 492 · 2020: 336
- FWCI
- 40.81
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
- Dipòsit Digital de la Universitat de Barcelona (Universitat de Barcelona) (submittedVersion, public-domain)
- mediaTUM (Technical University of Munich) (submittedVersion)
- Funders
- Gilead Sciences
- Topics
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
- Keywords
- remdesivir, COVID-19 pandemic, SARS-CoV-2, treatment duration, antiviral therapy, hospitalized patients, pneumonia, clinical status, adverse events, RNA polymerase inhibitors, respiratory failure, alanine aminotransferase elevation, nausea, constipation, mechanical ventilation avoidance, cost-effectiveness
- MeSH terms
- Betacoronavirus, COVID-19, SARS-CoV-2, COVID-19 Drug Treatment, Adenosine Monophosphate, Adult, Aged, Alanine, Antiviral Agents, Drug Administration Schedule, Female, Hospitalization, Humans, Male, Middle Aged, Oxygen Inhalation Therapy, Pneumonia, Viral, Treatment Outcome, Coronavirus Infections, Pandemics
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