Hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo, according to a preliminary data analysis from a randomized, controlled trial involving 1,063 patients, which began on February 21, 2020, the National Institutes of Health (NIH) announced.
The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19.
An independent data and safety monitoring board (DSMB) overseeing the trial met on April 27 to review data and shared their interim analysis with the study team. Based upon their review of the data, they noted that remdesivir was better than placebo from the perspective of time to recovery, a metric often used in influenza trials.
Recovery in this study (known as the Adaptive COVID-19 Treatment Trial, or ACTT) was defined as being well enough for hospital discharge or returning to normal activity level.
Preliminary results indicate that patients who received remdesivir had a 31 percent faster time to recovery than those who received placebo. Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8 percent for the group receiving remdesivir versus 11.6 percent for the placebo group.
The first trial participant in the ACTT trial was an American who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan, and volunteered to participate in the study at the first study site, the University of Nebraska Medical Center/Nebraska Medicine, in February 2020. A total of 68 sites ultimately joined the study—47 in the United States and 21 in countries in Europe and Asia.
Remdesivir, developed by Gilead Sciences, is an investigational broad-spectrum antiviral treatment administered via daily infusion for 10 days.
