Cited by 7,267COVID-19 Clinical Research StudiesSARS-CoV-2 and COVID-19 ResearchRespiratory Support and Mechanisms

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Remdesivir for the Treatment of Covid-19 — Final Report

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Beigel, John H., Tomashek, Kay M., Dodd, Lori E., Mehta, Aneesh K., Zingman, Barry S., Kalil, Andre C., Hohmann, Elizabeth, Chu, Helen Y., Luetkemeyer, Annie, Kline, Susan, Lopez de Castilla, Diego, Finberg, Robert W., Dierberg, Kerry, Tapson, Victor, Hsieh, Lanny, Patterson, Thomas F., Paredes, Roger, Sweeney, Daniel A., Short, William R., Touloumi, Giota, Lye, David Chien, Ohmagari, Norio, Oh, Myoung-don, Ruiz-Palacios, Guillermo M., Benfield, Thomas, Fätkenheuer, Gerd, Kortepeter, Mark G., Atmar, Robert L., Creech, C. Buddy, Lundgren, Jens, Babiker, Abdel G., Pett, Sarah, Neaton, James D., Burgess, Timothy H., Bonnett, Tyler, Green, Michelle, Makowski, Mat, Osinusi, Anu, Nayak, Seema, Lane, H. Clifford·2020·New England Journal of Medicine

DOI 10.1056/nejmoa2007764PMC PMC7262788

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Abstract

BACKGROUND: Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious. METHODS: We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. RESULTS: A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%). CONCLUSIONS: Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).

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Authors: Beigel, J. H., Tomashek, K. M., Dodd, L. E., Mehta, A. K., Zingman, B. S., Kalil, A. C., Hohmann, E., Chu, H. Y., Luetkemeyer, A., Kline, S., Lopez de Castilla, D., Finberg, R. W., Dierberg, K., Tapson, V., Hsieh, L., Patterson, T. F., Paredes, R., Sweeney, D. A., Short, W. R., Touloumi, G., Lye, D. C., Ohmagari, N., Oh, M.-D., Ruiz-Palacios, G. M., Benfield, T., Fätkenheuer, G., Kortepeter, M. G., Atmar, R. L., Creech, C. B., Lundgren, J., Babiker, A. G., Pett, S., Neaton, J. D., Burgess, T. H., Bonnett, T., Green, M., Makowski, M., Osinusi, A., Nayak, S., & Lane, H. C.
Affiliations: National Institutes of Health (US)
From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) — all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical...
Corresponding author: Beigel, John H.
ORCID: Beigel, John H.
Dodd, Lori E.
Mehta, Aneesh K.
Zingman, Barry S.
Kalil, Andre C.
Hohmann, Elizabeth
Chu, Helen Y.
Luetkemeyer, Annie
Kline, Susan
Finberg, Robert W.
Dierberg, Kerry
Tapson, Victor
Patterson, Thomas F.
Paredes, Roger
Short, William R.
Touloumi, Giota
Lye, David Chien
Ohmagari, Norio
Oh, Myoung-don
Ruiz-Palacios, Guillermo M.
Benfield, Thomas
Fätkenheuer, Gerd
Atmar, Robert L.
Creech, C. Buddy
Lundgren, Jens
Babiker, Abdel G.
Pett, Sarah
Neaton, James D.
Burgess, Timothy H.
Bonnett, Tyler
Makowski, Mat
Nayak, Seema
Lane, H. Clifford
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2020-11-05
Volume: 383
Issue: 19
Pages: 1813-1826
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa2007764
PMC: PMC7262788
OpenAlex: W3027630905
Cited by: 7,267
References: 22
Citations by year: 2026: 146 · 2025: 324 · 2024: 518 · 2023: 901 · 2022: 1447 · 2021: 2475 · 2020: 1451
FWCI: 206.47
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations: New England Journal of Medicine (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, other-oa)
Figshare (submittedVersion, cc-by)
Sussex Research Online (University of Sussex) (submittedVersion)
VBN Forskningsportal (Aalborg Universitet) (submittedVersion, other-oa)
eScholarship@McGill (McGill) (submittedVersion)
eScholarship (California Digital Library) (submittedVersion)
Seoul National University Open Repository (Seoul National University) (submittedVersion)
University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, other-oa)
Funders: Division of Intramural Research, National Institute of Allergy and Infectious Diseases
National Cancer Institute (HHSN261200800001E, HHSN261201500003I)
National Institute of Allergy and Infectious Diseases (UM1AI148450, UM1AI148452, UM1AI148573, UM1AI148575, UM1AI148576, UM1AI148684, UM1AI148685, UM1AI148689)
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, antiviral therapy, hospitalized patients, lower respiratory tract infection, time to recovery, mortality, serious adverse events, clinical improvement, treatment efficacy, SARS-CoV-2 RNA load, viral load reduction, disease severity, prognostic factors, prognostic score
MeSH terms: Betacoronavirus, COVID-19, SARS-CoV-2, COVID-19 Drug Treatment, Adenosine Monophosphate, Adult, Aged, Alanine, Antiviral Agents, Double-Blind Method, Female, Humans, Male, Middle Aged, Oxygen Inhalation Therapy, Pneumonia, Viral, Respiration, Artificial, Time Factors, Extracorporeal Membrane Oxygenation, Coronavirus Infections, Kaplan-Meier Estimate, Young Adult, Pandemics, Administration, Intravenous

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