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May 22, 2020New England Journal of Medicine7,761 citationsOpen Access

Remdesivir for the Treatment of Covid-19 — Final Report

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JBJohn H. BeigelKTKay M TomashekLDLori E. Dodd

Key Points

  • Remdesivir significantly reduced the median recovery time to 10 days compared to 15 days for placebo.
  • The odds of clinical improvement at day 15 were 1.5 times higher for patients receiving remdesivir.
  • Double-blind, randomized, placebo-controlled trial assessed remdesivir in hospitalized adults with lower respiratory tract infection related to Covid-19, involving 1062 patients overall for analysis of recovery metrics and adverse effects details throughout the intervention period of up to 10 days and additional follow-ups for mortality rates over 29 days post-treatment. It showed significant benefits against placebo outcomes in multiple measured aspects of recovery and survival despite noted adverse events in both groups, leading to strong implications for clinical treatment standards in Covid-19 management.

Abstract

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. 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. 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%). 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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Cite This Study

Beigel et al. (2020) studied this question.

synapsesocial.com/papers/68f2b31d40a4b9b73ec08d26https://doi.org/10.1056/nejmoa2007764
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