Genentech launches phase III trial to treat patients with COVID-19 pneumonia

Genentech, a member of the Roche Group, will launch a phase III clinical trial in April to evaluate the safety and efficacy of intravenous Actemra (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia.

Actemra was the first humanised interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. 

The primary and secondary endpoints of this COVID-19 study include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients will be followed for 60 days post-randomisation, and an interim analysis will be conducted to look for early evidence of efficacy.

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To date, several independent clinical trials have begun globally to explore the efficacy and safety of Actemra for the treatment of patients with COVID-19 pneumonia. 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.

Actemra is under study as a COVID-19 treatment in two active Chinese clinical studies, according to the Chinese Clinical Trials Registry:

1. A 150-patient trial assessing Actemra in combination with favipiravir, a broad spectrum anti-viral agent (ChiCTR2000030894), led by Hong Zhao of Peking University First Hospital.
2. A 188-patient trial assessing Actemra alone (ChiCTR2000029765), led by Dongsheng Wang of The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital).

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