The REMDACTA is a two-armed global phase III, randomised, double-blind and multicentre study designed to assess the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir against placebo plus remdesivir in hospitalised patients with severe Covid-19 pneumonia.
The phase III study, which is being conducted in collaboration with Gilead Sciences, will begin enrolment in June with a target of around 450 patients across the globe.
REMDACTA trial’s primary and secondary endpoints comprise of clinical status, mortality, mechanical ventilation, and intensive care variables. Patients will be monitored for 60 days of post-randomisation.
Roche already secured emergency use authorisation from the US Food & Drug Administration (FDA) for remdesivir to treat hospitalised patients with severe Covid-19.
Remdesivir is an investigational antiviral drug, which is being assessed in multiple ongoing international clinical trials.
Actemra/RoActemra is claimed to be the first approved anti-IL-6 receptor biologic available in both intravenous (IV) and subcutaneous (SC) formulations to treat adult patients with moderate-to-severe active rheumatoid arthritis (RA).
In March, Roche first announced that it will begin a phase III clinical trial of Actemra/RoActemra (tocilizumab) in hospitalised patients with severe Covid-19 pneumonia.
Roche is also near to completing recruitment of the COVACTA phase III randomised, double-blind and placebo-controlled clinical trial, which is designed to assess the safety and efficacy of intravenous Actemra/RoActemra plus standard of care (SOC) against placebo plus SOC in hospitalised adult patients with severe Covid-19 pneumonia.
Roche chief medical officer and global product development head Dr Levi Garraway said: “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.
“We’re pleased to partner with Gilead to determine whether combining these medicines could potentially help more patients during this pandemic.”