On Mar. 19, 2020, Roche announced it was working with the U.S. Food & Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), to evaluate the safety and efficacy of Actemra/RoActemra (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.

This was the first global study of Actemra/RoActemra in this setting and is expected to begin enrolling as soon as possible in early April with a target of approximately 330 patients globally, including the U.S. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.