Roche initiates phase III clinical trial of Actemra/RoActemra plus remdesivir in hospitalised patients with severe COVID-19 pneumonia

• Roche is also close to completing enrolment of a global randomised, double-blind, placebo-controlled phase III clinical trial of Actemra/RoActemra (tocilizumab) in hospitalised patients with severe COVID-19 pneumonia (COVACTA), with results expected this summer.

Basel, 28 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the initiation of a global phase III, randomised, double-blind, multicentre study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc. 

“As more information about COVID-19 pneumonia becomes available in these unprecedented times, it is more important than ever to work together to fight this disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Based on our current understanding, we believe that combining an antiviral with an immune modulator could potentially be an effective approach to treating patients with severe disease. We're pleased to partner with Gilead to determine whether combining these medicines could potentially help more patients during this pandemic.”

The study is expected to begin enrolling in June with a target of approximately 450 patients globally, including the US, Canada and Europe.

In addition to REMDACTA, Roche is close to completing enrolment of the global randomised, double-blind, placebo-controlled phase III clinical trial (COVACTA, NCT04320615) to evaluate the safety and efficacy of intravenous Actemra/RoActemra plus standard of care (SOC), versus placebo plus SOC in hospitalised adult patients with severe COVID-19 pneumonia. The first patient was randomised on April 3. In total, approximately 450 patients will be enrolled in COVACTA. This increase from the original target of 330 patients will allow for even more robust data, while minimally extending the recruitment period. Roche is committed to sharing data from the COVACTA study as soon as possible this summer. In addition, the protocol for COVACTA allows the inclusion of patients who are being treated with antivirals, including investigational antivirals. Data from the REMDACTA trial are designed to supplement the COVACTA study.