This study summary is an excerpt from the book 2 Minute Medicine’s The Classics in Medicine: Summaries of the Landmark Trials
1. This study determined that amongst adults hospitalized with COVID-19 with evidence of lower respiratory tract infection, remdesivir was superior to placebo in shortening time to recovery.
2. Serious adverse events were reported as generally similar between the remdesivir and placebo group (24.6% of patients randomized to receive remdesivir, compared to 31.6% in patients receiving placebo).
Original Date of Publication: October 2020
Study Rundown: Since SARS-CoV-2 was first identified in December 2019, several therapeutic agents have been evaluated as treatment modalities; however, none have yet been shown to be efficacious. Remdesivir is an antiviral agent that has shown ability to inhibit SARS-CoV-2 in vitro but has not yet been studied in hospitalized patients with COVID-19. The objective of this randomized controlled trial was to evaluate the clinical efficacy and safety profile of remdesivir in hospitalized patients with COVID-19 and evidence of lower respiratory infection compared to placebo. Final results demonstrated remdesivir was superior to placebo in shortening time to recovery amongst patients hospitalized with COVID-19. Limitations of this study include a short follow-up period for patients with more severe disease (higher ordinal score); therefore, median recovery time in this population could not be estimated. Nonetheless, this study was significant in suggesting remdesivir as the first efficacious drug for COVID-19.
In-Depth [randomized control trial]: A total of 1062 patients hospitalized with COVID-19 and evidence of lower respiratory infection underwent 1:1 randomization in The Adaptive COVID-19 Treatment Trial (ACTT-1) across 60 trial sites. Patients were either randomized to receive remdesivir (n = 541) (intravenous 200 mg loading dose day 1, followed by 100 mg daily for up to 9 days) or normal saline placebo (n = 521) for up to 10 days. Results demonstrated that patients in the remdesivir group had shortened time to recovery compared to placebo (median = 10 days compared to 15 days; RR 1.29; 95%CI 1.12-1.49; p < 0.001). Patients who received remdesivir were also more likely to have clinical improvement at day 15 compared to placebo (OR 1.5; 95%CI 1.2-1.9, after adjustment for actual disease severity). Serious adverse events occurred in 24.6% (n = 131) of patients randomized to receive remdesivir, compared to 31.6% (n = 163) in patients receiving placebo. The incidence of adverse events was reported to be generally similar between the two treatment groups. Altogether, the results of this study support the use of remdesivir in patients hospitalized with COVID-19, suggesting decreased length of stay in this patient population. However, considering the high mortality despite remdesivir treatment, it is likely a single antiviral treatment is insufficient in the treatment of COVID-19.
Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, et al. Remdesivir for the Treatment of COVID-19 — Final Report. New England Journal of Medicine. 2020 May 22.
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