Genentech is launching a phase 3 clinical trial evaluating tocilizumab (Actemra) plus standard of care for use in hospitalized adult patients with severe COVID-19 pneumonia, according to a company press release.
Tocilizumab, a humanized interleukin-6 (IL-6) receptor antagonist, is currently approved for the treatment of adult patients with moderately-to-severely active rheumatoid arthritis who have used 1 or more disease-modifying antirheumatic drugs that did not provide relief.
The phase 3 study aims to investigate the safety and efficacy of tocilizumab when used in patients with COVID-19, looking at clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) variables as primary and secondary endpoints.
Several independent clinical trials have examined the use of tocilizumab in treating patients with COVID-19 pneumonia and the treatment has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission, according to Genentech. However, there are currently no well-controlled studies and limited evidence backing the drug’s use in this setting.
This study will evaluate the safety and efficacy of intravenous tocilizumab added to standard of care in adults hospitalized with severe COVID-19 pneumonia compared with placebo plus standard of care. Patients will be followed for 60 days post-randomization and an interim analysis will be conducted to look for early evidence of efficacy.
“We are initiating a clinical trial to study Actemra for the treatment of people hospitalized with COVID-19 pneumonia, so that we can better establish the potential role for Actemra in fighting this disease,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development said in a statement. “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.”
1. Genentech Initiates Phase III Clinical Trial of Acetmra In Hospitalized Patients With Severe COVID-19 Pneumonia [news release]. Genentech’s website. https://www.gene.com/media/press-releases/14841/2020-03-18/genentech-initiates-phase-iii-clinical-t. Accessed March 19, 2020.