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Genentech Initiates Phase III Trial Of Actemra Plus Remdesivir On Severe COVID-19 Pneumonia

Genentech said that, in collaboration with Gilead Sciences, it has initiated a global Phase III, randomized, double-blind, multicenter study REMDACTA to evaluate the safety and efficacy of Actemra or tocilizumab plus the investigational antiviral remdesivir, compared to placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia.

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

In addition, Genentech, a member of the Roche Group, said that it is close to completing enrollment of the global randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the safety and efficacy of intravenous Actemra plus standard of care or SOC, versus placebo plus SOC in hospitalized adult patients with severe COVID-19 pneumonia. The first patient was randomized on April 3. In total, about 450 patients will be enrolled in COVACTA.

The increase from the original target of 330 patients will allow for even more robust data, while minimally extending the recruitment period. Actemra is not currently approved for this use by the U.S. Food and Drug Administration.

Genentech said it 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.

Genentech has also initiated a national Phase III double-blind, placebo-controlled randomized trial that will focus on recruiting about 375 patients at trial sites known to provide critical care to underserved and minority populations that often do not have access to clinical trials.

Remdesivir has been issued an Emergency Use Authorization by the FDA for the treatment of hospitalized patients with severe COVID-19.

Remdesivir is an investigational antiviral drug that is being studied in multiple ongoing international clinical trials, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established. Remdesivir has not been approved by the FDA for any use.

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