The Brigham was selected as a clinical trial site for evaluating an antiviral medication for patients with moderate and severe COVID-19
This week, Brigham and Women’s Hospital began enrolling patients in two clinical trials for Gilead’s antiviral medication remdesivir. The Brigham is one of multiple clinical trial sites for a Gilead-initiated study of the drug in 600 participants with moderate coronavirus disease (COVID-19) and a Gilead-initiated study of 400 participants with severe COVID-19.
“The trial duration will be 28 days per patient. At the rate of the current epidemic, we may be fully enrolled in the next month or so,” said Francisco Marty, MD, a physician in the Brigham’s Division of Infectious Disease who is the principal investigator for the trial. “This means that results may be available in the next two months. If the results are promising, this could lead to FDA approval, and if they aren’t, it gives us critical information in the fight against COVID-19 and allows us to move on to other therapies.”
The randomized, open-label phase 3 trials will evaluate the safety and efficacy of remdesivir compared to standard of care. For the trial of severe patients, the primary outcomes will be the normalization of temperature and oxygen saturation through day 14; in the trial of moderate patients, the primary outcome will be time to discharge. Patients will be randomized to either a five-day or 10-day regimen of remdesivir in addition to standard of care. Other trials, including a placebo-controlled clinical trial organized by the National Institutes of Health, are underway at other sites.
There are currently no therapeutics approved by the Food and Drug Administration for the treatment of COVID-19. Remdesivir is an investigational broad-spectrum antiviral medication that has not been approved for any use. The drug was originally developed with the goal of treating Ebola virus disease and Marburg virus infection but has shown activity against other viruses in animal models.