Preliminary data from a National Institutes of Health (NIH) clinical trial show Gilead Sciences' remdesivir accelerates recovery in patients with advanced coronavirus disease 2019 (COVID-19) infections.
Preliminary data from a National Institues of Health clinical trial show Gilead Sciences' remdesivir accelerates recovery in patients with advanced coronavirus disease 2019 (COVID-19) infections.
The randomized controlled trial began on February 21, closed to new enrollments on April 19, and involved 1063 patients with advanced COVID-19 and lung involvement. This was the first clinical trial launched in the United States aimed at evaluating a treatment for the disease.
The National Institute of Allergy and Infectious Diseases (NIAID) sponsored the Adaptive COVID-19 Treatment Trial (ACTT). ACTT was specifically designed to incorporate additional investigative treatments as the pandemic progresses.
An independent data and safety monitoring board (DSMB) found “remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials.” The researchers defined recovery as patients being well enough for hospital discharge or returning to normal activity level. However, the study has yet to be peer reviewed.
Results showed patients who received the treatment had a 31% faster recovery time compared with those who received placebo (P <.001). This amounted to a recovery time of 11 days in the intervention cohort compared with 15 days in the control group. “Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (P = .059),” the researchers noted.
In response to the preliminary data, the FDA plans to announce an emergency use authorization for the treatment, while Anthony Fauci, MD, director of NIAID, said results were “very optimistic,” The New York Times reports.
“Although a 31% improvement doesn’t seem like a knockout 100%, it is a very important proof of concept, because what it has proven is that a drug can block this virus,” Dr. Fauci said.
Even with promising early results, remdesivir is an experimental drug, and it may take months for enough supply to become available for large numbers of patients. The treatment was first developed to fight Ebola but clinical trials in Africa yielded disappointing results.
Detailed information about the trial results and more comprehensive data will become available in a future report, according to the NIH. Sixty-eight sites were involved in the study including: 47 in the United States and 21 countries in Europe and Asia.
Remdesivir is an investigational broad-spectrum antiviral treatment “administered via daily infusion for 10 days.” It is currently not licensed or approved in any country. In addition, the treatment “has not yet been demonstrated to be safe or effective for the treatment of COVID-19,” Gilead said in a statement.
In a separate placebo-controlled multicenter study published April 29, researchers found remdesivir offered no benefit to patients with COVID-19. “In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits,” they concluded.
Wang Y, Zhang D, Du G, et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial [published online April 29, 2020]. J Lancet. doi:10.1016/S0140-6736(20)31022-9.