A phase 3 clinical trial that will utilize a mix of Actemra/RoActemra and remdesivir on hospitalized COVID-19 patients with severe pneumonia is expected to begin in June, as part of a collaboration between Roche and Gilead Sciences, Inc.
That trial, REMDACTA, will be double-blind, randomized, and conducted at multiple centers, enrolling approximately 450 patients globally when all is said and done. The investigational antiviral remdesivir currently operates under an Emergency Use Authorization provided by the U.S. Food and Drug Administration (FDA) earlier this year. That authorization allows it for the treatment of patients hospitalized with severe cases of COVID-19. Still undergoing study itself, it showed promise in previous studies, including a National Institute of Allergy and Infectious Diseases (NIAID) test in which it demonstrated faster average recoveries against those taking placebos.
On its own, however, it did not significantly improve patients’ chances of survival, so researchers have begun to look at its capabilities as a mix.
“As more information about COVID-19 pneumonia becomes available in these unprecedented times, it is more important than ever to work together to fight this disease,” said Dr. Levi Garraway, Roche’s chief medical officer and head of Global Product Development. “Based on our current understanding, we believe that combining an antiviral with an immune modulator could potentially be an effective approach to treating patients with severe disease. We’re pleased to partner with Gilead to determine whether combining these medicines could potentially help more patients during this pandemic.”
While work on REMDACTA continues, Roche intends to enroll for another randomized, double-blind, placebo-controlled phase 3 clinical trial to evaluate the safety and efficacy of intravenous Actemra/RoActemra when paired with a standard of care on hospitalized adult patients with severe COVID-19 pneumonia, pitted against placebos. Known as COVACTA, that trial intends to enroll another approximately 450 patients, with results expected as early as this summer. REMDACTA data will supplement the COVACTA study.
While Roche and Gilead work together on REMDACTA, Roche’s partners in COVACTA include the FDA and the Biomedical Advanced Research and Development Authority.