Preliminary results of the Adaptive COVID-19 Treatment Trial (ACTT) investigating remdesivir for the treatment of COVID-19 in hospitalized adults with evidence of lower respiratory tract involvement has been published in the New England Journal of Medicine. Of the FHI Clinical study team members, Danielle Fisher, Clinical Research Project Manager, and Wendi McDonald, Associate Project Manager, are listed on the manuscript for their contributions to the study.
Of the FHI Clinical study team members, Danielle Fisher, Clinical Research Project Manager, and Wendi McDonald, Associate Project Manager, are listed on the manuscript for their contributions to the study.
Danielle Fisher, Clinical Research Project Manager (left), and Wendi McDonald, Associate Project Manager (right), represent FHI Clinical in the Adaptive COVID-19 Treatment Trial (ACTT) of remdesivir to treat COVID-19.
Funded by the National Institute of Allergy and Infectious Diseases, this randomized, double-blinded, placebo-controlled trial was conducted with 1063 participants recruited within an 8-week period at 60 study sites and 13 subsites in the United States (45 sites), Denmark (8), United Kingdom (5), Greece (4), Germany (3), Korea (2), Mexico (2), Spain (2), Japan (1) and Singapore (1). Intravenous remdesivir or placebo (plus standard care) was administered for up to 10 days, to determine the effect on time recovery (discharge or change in status to infection control only).
Due to the rapid enrollment pace, an interim review by the Data and Safety Monitoring Board (DSMB) occurred after enrollment was completed but while follow-up was ongoing. Because the interim results showed shortened time to recovery with remdesivir, the DSMB recommended early unblinding of the results. With these preliminary results, the study team determined that patients receiving remdesivir had a statistically significant shorter median recovery of 11 days, compared with 15 days with placebo, as well as lower mortality rates. The rates of adverse events were similar between the groups.
Although multiple therapeutic agents are being rapidly evaluated for the treatment of COVID-19, none have yet been proven efficacious. Based on these promising results, the authors conclude that remdisivir is superior to standard care alone in improving time to recovery in adults hospitalized with COVID-19 and evidence of lower respiratory tract infection.
The FHI Clinical team is excited to be part of this important work to find efficacious and safe treatments for COVID-19. Additional information about the study can be found on clinicaltrials.gov, and the manuscript will be updated once follow-up is complete and results from the full analyses are available.
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