Roche provides update on the phase III REMDACTA trial of Actemra/RoActemra plus Veklury in patients with severe COVID-19 pneumonia.

Roche has announced that the global phase III randomised, double-blind, multicentre REMDACTA study of Actemra/RoActemra (tocilizumab) plus Veklury (remdesivir), versus placebo plus Veklury, did not meet its primary endpoint. This was measured by improved time to hospital discharge up to day 28 in patients with severe COVID-19 pneumonia receiving standard of care. No new safety signals were identified for Actemra/RoActemra in the REMDACTA trial. The study was conducted in collaboration with Gilead Sciences, Inc. Roche will continue to evaluate data from the REMDACTA, COVACTA and EMPACTA studies as well as other studies of Actemra/RoActemra in COVID-19 pneumonia. The EMPACTA study met its primary endpoint, while COVACTA did not meet its primary endpoint. 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 fo.<>pr intensive care and/or ventilator use, as well as supplemental oxygen requirements. Patients will be followed for 60 days post-randomisation.