Roche’s Phase III Trial of Actemra in COVID-19 Misses Primary Endpoint

Roche’s Phase III COVACTA study of Actemra/RoActemra (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia. Also, the key secondary endpoints, which included the difference in patient mortality at week four, were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra. The COVACTA study did not identify any new safety signals for Actemra/RoActemra.  

The COVACTA trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.

COVACTA evaluated the safety and efficacy of intravenous Actemra/RoActemra added to standard-of-care treatment compared to treatment with placebo plus standard of care. The primary endpoint of clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia measured patients’ clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements. The COVACTA trial is the first global, randomized, double-blind, placebo-controlled Phase III study to investigate Actemra/RoActemra in hospitalized patients with severe COVID-19 associated pneumonia.