The FDA has approved a randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the safety and efficacy of intravenous (IV) tocilizumab (Actemra) plus standard of care in hospitalized adult patients with severe coronavirus disease 2019 (COVID-19) pneumonia, according to Genentech, the agent’s developer.
The clinical trial, called COVACTA, is being conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate tocilizumab combined with standard of care versus placebo plus standard of care.
Genentech has also indicated that they will provide 10,000 vials of tocilizumab to the US Strategic National Stockpile for future use at the direction of the US Department of Health and Human Services to further support the COVID-19 response efforts.
“We thank the FDA for rapidly expediting the approval of this clinical…
