logo
Plus   Neg
Share
Email

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Ford has revived the iconic Bronco brand after a gap of 24 years, this time as a dedicated off-road brand aiming to take on Fiat Chrysler's Jeep Wrangler, the dominant vehicle in the off-road category. Ford has introduced three new vehicles under the all-new Bronco brand as a 4x4 family of rugged SUVs under the tagline, "Built Wild". 3M Co. is teaming with researchers at Massachusetts Institute of Technology or MIT to develop a new rapid antigen test that detects the COVID-19 virus. The research, being conducted at the pilot lab facility at 3M's headquarters in St. Paul, Minnesota, is to learn if a simple-to-use, diagnostic device can produce highly accurate results within minutes and is feasible to mass manufacture. Retail giant Walmart has teamed up with the U.S. Department of Agriculture (USDA) to enable customers who pay for groceries with SNAP benefits, to gain access to Walmart's pickup and delivery service. Nearly 3,000 Walmart stores in 39 U.S. states are now offering customers receiving SNAP benefits through their Electronic Benefit Transfer (EBT) card to complete payments using the EBT card.
Follow RTT