Roche has launched a Phase III study in collaboration with Gilead to evaluate the safety and efficacy of Actemra/RoActemra (tocilizumab) in combination with remdesivir in hospitalised patients with severe COVID-19 pneumonia.
The REMDACTA trial, in which patients will either receive the combination or one containing a placebo plus remdesivir alongside standard of care, is expected to begin enrolling patients in June with a target of approximately 450 subjects globally.
The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care variables, and patients will be followed for 60 days post-randomisation.
Roche is also close to completing enrolment of the global randomised, double-blind, placebo-controlled Phase III clinical trial (COVACTA) to evaluate the safety and efficacy of intravenous Actemra/RoActemra plus standard of care (SOC), versus placebo plus SOC in hospitalised adult patients with severe COVID-19 pneumonia.
“As more information about COVID-19 pneumonia becomes available in these unprecedented times, it is more important than ever to work together to fight this disease,” said Levi Garraway, Roche’s chief medical officer and head of Global Product Development.
"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.”