Remdesivir for the Treatment of Covid-19 — Final Report
RCT 1,062 hospitalized patients showing faster recovery time with treatment, median 10 days vs. 15 days for placebo, rate ratio for recovery 1.29,
p<0.001. Day 29 mortality was 11.4% with remdesivir and 15.2% with placebo, hazard ratio HR 0.73 [0.52-1.03].
[Gérard, Wu, Zhou] show significantly increased risk of acute kidney injury with remdesivir.
risk of death, 27.0% lower, HR 0.73, p = 0.07, treatment 541, control 521.
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risk of no recovery, 22.5% lower, RR 0.78, p < 0.001, treatment 541, control 521, inverted to make RR<1 favor treatment.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Beigel et al., 8 Oct 2020, Randomized Controlled Trial, USA, peer-reviewed, 12 authors, average treatment delay 9.0 days.
Abstract: new england
journal of medicine
The
established in 1812
November 5, 2020
vol. 383
no. 19
Remdesivir for the Treatment of Covid-19 — Final Report
J.H. Beigel, K.M. Tomashek, L.E. Dodd, A.K. Mehta, B.S. Zingman, A.C. Kalil, E. Hohmann, H.Y. Chu,
A. Luetkemeyer, S. Kline, D. Lopez de Castilla, R.W. Finberg, K. Dierberg, V. Tapson, L. Hsieh, T.F. Patterson,
R. Paredes, D.A. Sweeney, W.R. Short, G. Touloumi, D.C. Lye, N. Ohmagari, M. Oh, G.M. Ruiz‑Palacios,
T. Benfield, G. Fätkenheuer, M.G. Kortepeter, R.L. Atmar, C.B. Creech, J. Lundgren, A.G. Babiker, S. Pett,
J.D. Neaton, T.H. Burgess, T. Bonnett, M. Green, M. Makowski, A. Osinusi, S. Nayak, and H.C. Lane,
for the ACTT-1 Study Group Members*
a bs t r ac t
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%).
The authors’ full names, academic degrees, and affiliations are listed in the
Appendix. Address reprint requests to Dr.
Beigel at the National Institute of Allergy
and Infectious Diseases, National Institutes
of Health, 5601 Fishers Ln., Rm. 7E60,
MSC 9826, Rockville, MD 20892-9826, or
at jbeigel@niaid.nih.gov.
*A complete list of members of the
ACTT-1 Study Group is provided in the
Supplementary Appendix, available at
NEJM.org.
A preliminary version of this article was
published on May 22, 2020, at NEJM.org.
This article was published on October 8,
2020, and updated on October 9, 2020, at
NEJM.org.
N Engl J Med 2020;383:1813-26.
DOI: 10.1056/NEJMoa2007764
Copyright © 2020 Massachusetts Medical Society.
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..
Late treatment
is less effective
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