BASEL — Roche announced  Thursday that the company is working with the Food & Drug Administration (FDA) to initiate a randomised, 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/RoActemra (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.

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This is 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 U.S. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.

“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 Dr. Levi Garraway., 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.”

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 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/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 Food and Drug Administration (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.