Genentech initiates phase III clinical trial of Actemra in hospitalized patients with severe COVID-19 pneumonia.
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Published:20th Mar 2020
Genentech, a member of the Roche Group announced that the company is working with the FDA to initiate 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), to evaluate the safety and efficacy of Actemra (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. This is the first global study of Actemra 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 United States. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. To date, there are several independent clinical trials exploring the efficacy and safety of Actemra for the treatment of patients with COVID-19 pneumonia. Actemra has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC) on March 3, 2020. However, this new trial is vital because there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra in the treatment of patients suffering from COVID-19. In addition, Actemra is not currently approved for this use by any health authorities, including the FDA. In addition to initiating this trial, Roche received FDA Emergency Use Authorization for the cobas® SARS-CoV-2 Test on March 13, 2020, to detect the novel virus that causes COVID-19 disease.