Phase III Clinical Trial Underway of Actemra/RoActemra Plus Remdesivir to Treat Severe COVID-19 Pneumonia

Roche is starting a global phase III, randomized, double-blind, multicenter study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra (tocilizumab) plus remdesivir in hospitalized patients with severe coronavirus disease 2019 (COVID-19) pneumonia.

Initiated in collaboration with Gilead Sciences, Inc., the study will test tocilizumab plus remdesivir vs placebo plus remdesivir, Roche announced in their May 28, 2020 press release.

“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, MD, PhD, chief medical officer, head of global product development, Roche, Basel, Switzerland, in the press release. "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.”

Global study enrollment is set to begin in June and include approximately 450 patients hospitalized with severe COVID-19 pneumonia receiving standard of care (SOC) for 60 days post-randomization.

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.

The primary and secondary endpoints include clinical status, mortality, mechanical ventilation, and intensive care variables.

Furthermore, Roche is close to completing enrollment of a second global, randomized, double-blind, placebo-controlled phase III clinical trial (COVACTA) to evaluate the safety and efficacy of intravenous tocilizumab plus SOC vs placebo plus SOC in hospitalized adult patients with severe COVID-19 pneumonia.

Data from the REMDACTA study are designed to supplement the COVACTA study, in which the first patient was randomized on April 3, 2020. Data from COVACTA is expected to be released this summer.

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