The antiviral treatment remdesivir accelerated recovery time among hospitalized participants with advanced COVID-19 compared to participants who received placebo containing inactive ingredients, according to results of a clinical trial published May 22 in the New England Journal of Medicine.
The median time to recovery was 11 days for participants who received remdesivir compared to 15 days for participants who received placebo.
The trial, known as the Adaptive COVID-19 Treatment Trial (ACTT), is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Rapid response teams from the Frederick National Laboratory for Cancer Research (FNL) helped NIAID set up and support 40 clinical study sites in the United States, Mexico, Europe, and Asia, to obtain the required regulatory approvals, coordinate and manage multi-site activities, coordinate the contractual arrangements across the sites, ensure adequacy of supplies and materials to conduct the trial and set up and maintain a 24-hour call center.
“Supporting this clinical trial during a pandemic was a challenge for all involved, yet it is one we met with great resolve,” said Beth Baseler, director of the FNL’s Clinical Monitoring Research Program. “Our inspiration came from the research staff at sites around the world who conducted vital clinical research under extremely difficult conditions.”
ACTT is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19. The randomized, controlled trial enrolled 1,063 participants with the first participant enrolled on February 21. On April 27, an interim analysis conducted by an independent data and safety monitoring board showed remdesivir improved recovery time as compared to the placebo group, defined as being well enough to be discharged or return to normal activities.
Trial results suggested a survival benefit, but the difference was not statistically significant. By day 14, 7.1 percent of participants on remdesivir died compared to 11.9 percent in the placebo group.
Since the interim analysis showed the benefit of remdesivir and at the recommendation by the Data Safety and Monitoring Board, all individuals in the clinical trial were offered the treatment. The U.S. Food and Drug Administration has made remdesivir available under an Emergency Use Authorization for the treatment of adults and children with severe COVID-19 disease.
Authors of the study pointed out that while remdesivir accelerated recovery time for participants hospitalized with COVID-19, the disease has a high mortality despite remdesivir use.
ACTT is an adaptive clinical trial. The next iteration of the study, known as ACTT-2, is now open and new participants will receive remdesivir plus an anti-inflammatory drug called baricitinib or remdesivir alone.Tagged: