Roche Initiates Phase III Clinical Trial for Patients Hospitalized with Severe COVID-19 Pneumonia

Roche (Basel, Switzerland) has begun working with the Food & Drug Administration (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 US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), to evaluate the safety and efficacy of Actemra/RoActemra (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia as compared to placebo plus standard of care.

Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). Actemra/RoActemra can be used alone or with methotrexate (MTX) in adult RA patients who are intolerant to, or have failed to respond to, other disease-modifying anti-rheumatic drugs (DMARDs).

To date, there are several independent clinical trials exploring the efficacy and safety of Actemra/RoActemra for the treatment of patients with COVID-19 pneumonia. Actemra/RoActemra was also 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 will be 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 US. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.

The new trial is vital as there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra/RoActemra in the treatment of patients suffering from COVID-19. In addition, Actemra/RoActemra is not currently approved for this use by any health authorities, including the US FDA.

"We are initiating a clinical trial to study Actemra/RoActemra for the treatment of people hospitalized with COVID-19 pneumonia, so that we can better establish the potential role for Actemra/RoActemra in fighting this disease," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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.”

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