Preliminary Report of Remdesivir Trial Shows Improved Recovery Time in Severe COVID-19
Although several therapeutic agents have been evaluated for the treatment of COVID-19, none have yet shown to be effective.
Preliminary data from the Adaptive Covid-19 Treatment Trial (ACTT-1), which incorporated sites in 10 countries and evaluated the safety and efficacy of intravenous (IV) remdesivir, showed promising results for a 10-day course of remdesivir in shortening recovery time in adults hospitalized with coronavirus disease 2019 (COVID-19) and demonstrating evidence of lower respiratory tract infection.1
The study’s preliminary results, published in The New England Journal of Medicine, evaluated remdesivir in hospital settings in the US (45 sites), Denmark (8), the UK (5), Greece (4), Germany (3), Korea (2), Mexico (2), Spain (2), Japan (1), and Singapore (1).1,2 The 58-day trial began on February 21, 2020 and ended on April 19, 2020.2
The FDA made the drug available for treatment of severe COVID-19 in adults and children under an emergency use authorization (EUA) on May 1, 2020. The study’s investigators asserted that, “given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient. Future strategies should evaluate antiviral agents in combination with other therapeutic approaches or combinations of antiviral agents to continue to improve patient outcomes in COVID-19.”1
The multi-site, double-blind, randomized, placebo-controlled trial incorporated a total of 1063 patients who underwent randomization to receive either remdesivir or placebo; 541 were assigned to remdesivir treatment, while 522 were assigned to receive placebo. Those receiving IV remdesivir had a median recovery time of 11 days compared to 15 days in those receiving placebo.1
The Kaplan-Meier mortality estimates by 14 days were 7.1% with remdesivir treatment and 11.9% with placebo, additionally suggesting a survival benefit with IV remdesivir treatment for COVID-19.1,2
Investigators administered 200 mg of remdesivir intravenously as a loading dose on day 1, and then administered 100 mg maintenance doses daily on days 2 through 10 or until hospital discharge or death. Participants receiving placebo were administered according to the same schedule and in the same volume as remdesivir treatments.1
“Our preliminary report is intended to help inform clinicians considering the use of remdesivir. We are awaiting final visits, data entry, monitoring, and data lock for the last of the 1063 patients enrolled, after which an update of the results will be provided,” the investigators wrote.1
The trial was sponsored and primarily funded by the National Institute of Allergy and Infectious Disease (NIAID), National Institutes of Health, as well as the governments of Japan, Mexico, Denmark, and Singapore.1
On May 8, 2020, NIAID launched the ACTT 2 clinical trial, which is evaluating remdesivir in conjunction with the anti-inflammatory drug baricitinib compared with remdesivir treatment by itself.2
References:
1. Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the Treatment of Covid-19 – Preliminary Report. The New England Journal of Medicine. 2020; doi: 10.1056/NEJMoa2007764.
2. Peer-Reviewed Data Shows Remdesivir for COVID-19 Improves Time to Recovery. News Release. NIAID; May 22, 2020. Accessed May 27, 2020. https://www.niaid.nih.gov/news-events/peer-reviewed-data-shows-remdesivir-covid-19-improves-time-recovery.
