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Roche has started a Phase III clinical trial to assess its Actemra/RoActemra in combination with Gilead Sciences’ remdesivir to treat hospitalised Covid-19 patients with severe pneumonia.
Named REMDACTA, the randomised, double-blind, multi-centre trial will compare the safety and efficacy of the combination to remdesivir plus placebo.
Expected to commence patient enrolment next month, the study is designed to involve about 450 patients worldwide, including in the US, Europe and Canada.
The trial’s primary and secondary endpoints include clinical status, mortality, mechanical ventilation, and intensive care variables. Participants will be followed for 60 days after randomisation.
Roche chief medical officer and Global Product Development head 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.”
The company is also recruiting patients for a separate Phase III trial of Actemra called COVACTA.
This global, randomised, double-blind, placebo-controlled study is evaluating the safety and efficacy of intravenous formulation of the drug plus standard of care (SOC) in hospitalised adults with severe Covid-19 pneumonia.
The first patient for COVACTA, which is being performed in alliance with the US Food & Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA), was randomised on 3 April.
The study is originally designed to recruit 330 patients but the target has now been increased to 450. Results from COVACTA are expected to be made available in the coming months.
The study’s protocol enables the inclusion of patients being treated with antivirals, including experimental antivirals. Data from the REMDACTA trial are expected to supplement the COVACTA study.