- The REMDACTA clinical trial of Actemra/RoActemra plus Veklury did not meet its primary endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia or its key secondary endpoints compared to Veklury alone
Roche will submit the REMDACTA results to a peer-reviewed journal
“Given the global impact of COVID-19 pneumonia on patients, we are disappointed that the REMDACTA study did not meet its endpoints,” said
REMDACTA did not meet key secondary endpoints, which included likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status. The full results of the trial will be submitted for publication in a peer-reviewed journal later this year.
Actemra/RoActemra is not approved for the treatment of COVID-19 pneumonia.
The antiviral medication Veklury was invented and developed by Gilead Sciences and is approved or authorized for temporary use for the treatment of COVID-19 in approximately 50 countries worldwide.
For more information on how
About the REMDACTA Trial
REMDACTA is a two-armed global phase III, randomised, double-blind, multicentre study (REMDACTA, NCT04409262) to evaluate the efficacy and safety of Actemra/RoActemra plus Veklury, versus placebo plus Veklury in hospitalised patients with severe COVID-19 pneumonia receiving standard of care. Veklury is an antiviral medicine that works to stop replication of SARS-CoV-2, the virus that causes COVID-19. The REMDACTA trial is being conducted in collaboration with Gilead Sciences, Inc. The primary endpoint of the study is improvement in time to hospital discharge by Day 28. Key secondary endpoints include likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status. Clinical status is measured by the 7-category ordinal scale, which tracks patients’ clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements. Patients will be followed for 60 days post-randomisation.
About the COVACTA Trial
COVACTA is a global, randomised, double-blind, placebo-controlled phase III study (COVACTA, NCT04320615) which evaluated the safety and efficacy of intravenous Actemra/RoActemra added to standard of care in adult patients hospitalised with severe COVID-19 pneumonia compared to placebo plus standard of care. The primary and secondary endpoints included clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients were followed for 60 days post-randomisation.
About the EMPACTA Trial
EMPACTA (Evaluating Minority Patients with Actemra) is a phase III, randomised, double-blind, placebo-controlled multicentre study (EMPACTA, NCT04372186) which evaluated the efficacy and safety of Actemra/RoActemra in the treatment of hospitalised COVID-19 pneumonia among patients that are often underrepresented in clinical trials.
The primary endpoint was the cumulative proportion of participants dying or requiring mechanical ventilation by Day 28. Secondary endpoints included: time to clinical failure, defined as the time to death, mechanical ventilation, ICU admission, or withdrawal (whichever occurs first); mortality rate by Day 28; and time to hospital discharge or “ready for discharge.”
About Actemra/RoActemra
Actemra/RoActemra was the first approved anti-IL-6 receptor biologic, and is available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). Actemra/RoActemra can be used alone or with methotrexate (MTX) in adult RA patients who are intolerant to, or have failed to respond to, other disease-modifying anti-rheumatic drugs (DMARDs). In
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