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Remdesivir for the Treatment of Covid-19 - Final Report.

Publication ,  Journal Article
Beigel, JH; Tomashek, KM; Dodd, LE; Mehta, AK; Zingman, BS; Kalil, AC; Hohmann, E; Chu, HY; Luetkemeyer, A; Kline, S; Lopez de Castilla, D ...
Published in: N Engl J Med
November 5, 2020

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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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

November 5, 2020

Volume

383

Issue

19

Start / End Page

1813 / 1826

Location

United States

Related Subject Headings

  • Young Adult
  • Time Factors
  • SARS-CoV-2
  • Respiration, Artificial
  • Pneumonia, Viral
  • Pandemics
  • Oxygen Inhalation Therapy
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
 

Citation

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Beigel, J. H., Tomashek, K. M., Dodd, L. E., Mehta, A. K., Zingman, B. S., Kalil, A. C., … ACTT-1 Study Group Members. (2020). Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med, 383(19), 1813–1826. https://doi.org/10.1056/NEJMoa2007764
Beigel, John H., Kay M. Tomashek, Lori E. Dodd, Aneesh K. Mehta, Barry S. Zingman, Andre C. Kalil, Elizabeth Hohmann, et al. “Remdesivir for the Treatment of Covid-19 - Final Report.N Engl J Med 383, no. 19 (November 5, 2020): 1813–26. https://doi.org/10.1056/NEJMoa2007764.
Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, et al. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813–26.
Beigel, John H., et al. “Remdesivir for the Treatment of Covid-19 - Final Report.N Engl J Med, vol. 383, no. 19, Nov. 2020, pp. 1813–26. Pubmed, doi:10.1056/NEJMoa2007764.
Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh M-D, Ruiz-Palacios GM, Benfield T, Fätkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC, ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813–1826.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

November 5, 2020

Volume

383

Issue

19

Start / End Page

1813 / 1826

Location

United States

Related Subject Headings

  • Young Adult
  • Time Factors
  • SARS-CoV-2
  • Respiration, Artificial
  • Pneumonia, Viral
  • Pandemics
  • Oxygen Inhalation Therapy
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate