Roche Initiates Phase III Trial in COVID-19 Pneumonia

Roche initiated a global Phase III, randomized, double-blind study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc.

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

In addition to REMDACTA, Roche is conducting a global randomized, double-blind, placebo-controlled Phase III trial (COVACTA, NCT04320615) to evaluate the safety and efficacy of intravenous Actemra/RoActemra plus standard of care (SOC), versus placebo plus SOC in hospitalized patients with severe COVID-19 pneumonia. In total, approximately 450 patients will be enrolled in COVACTA and Roche expects data from the study 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.

The COVACTA study is conducted in collaboration with the U.S. FDA and BARDA. Roche is also a participant in the Accelerated COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, led by the National Institutes of Health (NIH).

Gilead’s Remdesivir was approved by the FDA under an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19. Remdesivir is an investigational antiviral drug being studied in multiple ongoing clinical trials, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established.