Remdesivir for 5 or 10 Days in Patients with Severe Covid-19
RCT of remdesivir for 5 or 10 days with no placebo control group, showing no significant differences between 5 and 10 day treatment. NCT04292899 (history)
show significantly increased risk of acute kidney injury with remdesivir.
n e w e ng l a n d j o u r na l
m e dic i n e
Remdesivir for 5 or 10 Days in Patients
with Severe Covid-19
Jason D. Goldman, M.D., M.P.H., David C.B. Lye, M.B., B.S., David S. Hui, M.D.,
Kristen M. Marks, M.D., Raffaele Bruno, M.D., Rocio Montejano, M.D.,
Christoph D. Spinner, M.D., Massimo Galli, M.D., Mi‑Young Ahn, M.D.,
Ronald G. Nahass, M.D., Yao‑Shen Chen, M.D., Devi SenGupta, M.D.,
Robert H. Hyland, D.Phil., Anu O. Osinusi, M.D., Huyen Cao, M.D.,
Christiana Blair, M.S., Xuelian Wei, Ph.D., Anuj Gaggar, M.D., Ph.D.,
Diana M. Brainard, M.D., William J. Towner, M.D., Jose Muñoz, M.D.,
Kathleen M. Mullane, D.O., Pharm.D., Francisco M. Marty, M.D.,
Karen T. Tashima, M.D., George Diaz, M.D., and Aruna Subramanian, M.D.,
for the GS-US-540-5773 Investigators*
A BS T R AC T
Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro
and efficacy in animal models of coronavirus disease 2019 (Covid-19).
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.
The authors’ affiliations are listed in the
Appendix. Address reprint requests to
Dr. Brainard at Gilead Sciences, 333 Lakeside Dr., Foster City, CA 94404, or at
*A list of investigators in the GS-US-5405773 trial is provided in the Supplementary Appendix, available at NEJM.org.
This article was published on May 27, 2020,
N Engl J Med 2020;383:1827-37.
Copyright © 2020 Massachusetts Medical Society.
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%).
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.)
n engl j med 383;19
November 5, 2020
The New England Journal of Medicine
Copyright © 2020..
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