Cited by 1,362COVID-19 Clinical Research StudiesSARS-CoV-2 and COVID-19 ResearchRespiratory Support and Mechanisms

Remdesivir for 5 or 10 Days in Patients with Severe Covid-19

Open access
Goldman, Jason D., Lye, David C.B., Hui, David S., Marks, Kristen M., Bruno, Raffaele, Montejano, Rocio, Spinner, Christoph D., Galli, Massimo +18 more·2020·New England Journal of Medicine

Abstract

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.).

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1056/nejmoa2015301

Cites

24 of 24 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Direct comparisons in which the evidence is dominated by unblinded studies were rated down, consistent with GRADE, for risk of bias.

    “Direct comparisons in which the evidence is dominated by unblinded studies were rated down, consistent with GRADE, for risk of bias and that is reflected in the rating of the quality of evidence from the network estimate.40”

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Cited by

Sorted by citations

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.
Venue
New England Journal of Medicine
Published
2020-11-05
Volume
383
Issue
19
Pages
1827-1837
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
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
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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review