Roche, Basel, Switzerland, has confirmed the initiation of a randomized, double-blind, placebo-controlled Phase III clinical trial, called Covacta, which will evaluate the safety and efficacy of the intravenous immunosuppressant drug Actemra/RoActemra (tocilizumab) on top of standard of care in hospitalized adult patients with severe covid-19 pneumonia, compared to placebo on top of standard of care.
The trial is being conducted in collaboration with the Biomedical Advanced Research and Development Authority, a part of the US Department of Health and Human Services office of the assistant secretary for preparedness and response. This is the first global study of Actemra/RoActemra in this setting.
“We are initiating a clinical trial to study Actemra/RoActemra for the treatment of people hospitalized with covid-19 pneumonia, so that we can better establish the potential role for Actemra/RoActemra in fighting this disease,” says Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development. “In these unprecedented times, today’s announcement is an important example of how industry and regulators can collaborate quickly to address the covid-19 pandemic, and we will share the results as soon as possible.”
At the moment, 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.
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