A phase 3 study evaluating the efficacy and safety of tocilizumab (Actemra®) in combination with the investigational antiviral remdesivir for the treatment of severe coronavirus disease 2019 (COVID-19) pneumonia is expected to begin soon. The trial is being conducted by Roche in collaboration with Gilead Sciences.
The global, multicenter, double-blind study (REMDACTA) is expected to begin enrollment in June with a target of approximately 450 hospitalized patients with severe COVID-19 pneumonia receiving standard of care (SOC). Patients will be randomized to receive either tocilizumab or placebo plus remdesivir, and will be followed for 60 days post-randomization. The primary and secondary end points of the trial include clinical status, mortality, mechanical ventilation, and intensive care variables.
“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,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.
Additionally, the Company is completing enrollment for its phase 3 study (COVACTA) comparing the efficacy and safety of tocilizumab to placebo plus SOC in approximately 450 hospitalized patients with severe COVID-19 pneumonia. Results from the COVACTA study are expected to be shared this summer.
Actemra, an interleukin-6 antagonist, is currently approved for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis or active polyarticular juvenile idiopathic arthritis, giant cell arteritis, and chimeric antigen receptor T cell-induced severe or life-threatening cytokine release syndrome.
For more information visit roche.com.