Genentech, a member of the Roche Group, has launched a phase III, randomized, double-blind, multicenter study (REMDACTA) to evaluate the safety and efficacy of Actemra (tocilizumab) plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia.
The trial, in collaboration with Gilead Sciences Inc., is expected to begin enrolling in June with a target of 450 patients.
“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,” Levi Garraway, Genentech chief medical officer and head of global product development, said in a statement.
In addition to REMDACTA, Genentech is close to completing enrollment of the global randomized, double-blind, placebo-controlled phase III clinical trial (COVACTA, NCT04320615) to evaluate the safety and efficacy of intravenous Actemra plus standard of care, versus placebo plus SOC in hospitalized adult patients with severe COVID-19 pneumonia.
Approximately 450 patients will be enrolled in COVACTA. This is an increase from the original target of 330 patients. Actemra is not currently approved for this use by FDA.
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 FDA and the Biomedical Advanced Research and Development Authority. Genentech is also a participant in the Accelerated COVID-19 Therapeutic Interventions and Vaccines partnership, led by NIH and the Foundation of the NIH.
Genentech has also initiated a national phase III double-blind, placebo-controlled randomized trial (EMPACTA, NCT04372186) that will focus on recruiting approximately 375 patients at trial sites known to provide critical care to underserved and minority populations that often do not have access to clinical trials.
