Roche and Gilead Collaborate to Test Actemra-Remdesivir Cocktail in Severe COVID-19 Cases
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By HospiMedica International staff writers Posted on 29 May 2020 |
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Roche (Basel, Switzerland) has initiated a phase III clinical trial of Actemra/RoActemra plus remdesivir in hospitalized patients with severe COVID-19 pneumonia.
The global randomized, double-blind, multi-centre study (REMDACTA) will evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences (Foster City, CA, USA). The study is expected to begin enrolling in June with a target of approximately 450 patients globally.
Remdesivir is an investigational antiviral drug that is being studied in multiple ongoing international clinical trials, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established. Remdesivir has been issued an Emergency Use Authorization by the US Food & Drug Administration (FDA) for the treatment of hospitalized patients with severe COVID-19.
In addition to REMDACTA, Roche is close to completing enrolment of the global randomised, double-blind, placebo-controlled phase III clinical trial (COVACTA, NCT04320615) to evaluate the safety and efficacy of intravenous Actemra/RoActemra plus standard of care (SOC), versus placebo plus SOC in hospitalized adult patients with severe COVID-19 pneumonia. In addition, the protocol for COVACTA allows the inclusion of patients who are being treated with antivirals, including investigational antivirals. Roche is committed to sharing data from the COVACTA study as soon as possible this summer. Data from the REMDACTA trial are designed to supplement the COVACTA study.
“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, M.D., Ph.D., 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.”
The global randomized, double-blind, multi-centre study (REMDACTA) will evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences (Foster City, CA, USA). The study is expected to begin enrolling in June with a target of approximately 450 patients globally.
Remdesivir is an investigational antiviral drug that is being studied in multiple ongoing international clinical trials, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established. Remdesivir has been issued an Emergency Use Authorization by the US Food & Drug Administration (FDA) for the treatment of hospitalized patients with severe COVID-19.
In addition to REMDACTA, Roche is close to completing enrolment of the global randomised, double-blind, placebo-controlled phase III clinical trial (COVACTA, NCT04320615) to evaluate the safety and efficacy of intravenous Actemra/RoActemra plus standard of care (SOC), versus placebo plus SOC in hospitalized adult patients with severe COVID-19 pneumonia. In addition, the protocol for COVACTA allows the inclusion of patients who are being treated with antivirals, including investigational antivirals. Roche is committed to sharing data from the COVACTA study as soon as possible this summer. Data from the REMDACTA trial are designed to supplement the COVACTA study.
“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, M.D., Ph.D., 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.”
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