In response to the COVID-19 pandemic, Roche have initiation of a randomized, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR). The study, COVACTA, will evaluate the safety and efficacy of intravenous Actemra/RoActemra (tocilizumab) on top of standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo.
This is the first global study of Actemra/RoActemra in this setting. In addition to the Roche trial, Roche is also carefully following independently-led clinical trials, on multiple medicines including Actemra, that are taking place around the world.
There are no robust, well-controlled studies showing safety and efficacy of Actemra in clinical treatment of COVID-19 pneumonia, and Actemra is not currently approved for this use.
With the announcement of new clinical trials, and a potential increase in demand for Actemra, Roche is working to accelerate manufacturing capacity to maximize production of Actemra wherever possible with the goal of increasing global supply.
Read the full Roche release