Roche (SIX: ROG) has started a global Phase III test of Actemra/RoActemra (tocilizumab), the company's arthritis treatment, in hospitalized adults with severe COVID-19 pneumonia. Actemra blocks the IL-6 receptor to slow a person's immune response. The randomized, double-blind, placebo-controlled trial will enroll 330 patients in the US and elsewhere. Roche, which formed an alliance with the US Biomedical Advanced Research and Development Authority (BARDA) to conduct the test, will assess the safety and efficacy of Actemra in combination with standard of care compared to placebo. China has already included Actemra as part of its COVID-19 treatment guidelines.

Following treatment, patients in the trial will be followed for 60 days post-randomization, and an interim analysis will be conducted to look for early evidence of efficacy, Roche said. The primary and secondary endpoints of the trial include clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) variables. The trial is expected to start in April.

Roche chief medical officer and Global Product Development head Levi Garraway said: “We are initiating a clinical trial to study Actemra/RoActemra for the treatment of people hospitalised with COVID-19 pneumonia, so that we can better establish the potential role for Actemra/RoActemra in fighting this disease. 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.”

The company noted that multiple independent studies are being conducted to assess the drug in COVID-19 patients with pneumonia. Roche said the trial will provide data from a well-controlled trial to detemine the efficacy of Actemra in this difficult to treat population.

The IL-6 protein triggers the body’s immune and inflammatory response to fight infections. But, in the case of those patients where their immune system overreacts, IL-6 inhibition could keep the body from attacking itself. Last week, Regeneron and Sanofi announced they would start a test of Kevazra, another IL-6 inhibitor, based on reports of Actemra's success in treating China patients.

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Disclosure: none.