TrialSite recently suggested based on unfolding study results that repurposed IL-6 inhibitors, such as Roche’s Actemra®/ReActemtra® (tocilizumab), may not work to treat patients infected with COVID-19. TrialSite pointed to the results of an Italian study as a potentially negative signal for the many other studies. Now Roche confirms this with a recent press release declaring that in the COVACTA study the immunosuppressive failed to meet its primary endpoint of improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia. Moreover, key secondary endpoints weren’t met either: the IL-6 inhibitor failed to evidence difference in patient mortality at week four.
The COVACTA study revealed at least one positive trend in time to hospital discharge in patients on tocilizumab. The COVACTA study didn’t reveal any new safety signals for Actemra/RoActemra. The company plans on conducting further analysis and will submit the findings for publication in a peer-reviewed journal.
The COVACTA Trial
This clinical trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.
COVACTA evaluated the safety and efficacy of intravenous Actemra/RoActemra added to standard-of-care treatment compared to treatment with placebo plus standard of care. The primary endpoint of clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia was measured by a 7-category ordinal scale, which tracked patients’ clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements. The COVACTA trial is the first global, randomized, double-blind, placebo-controlled phase III study to investigate Actemra/RoActemra in adult patients hospitalized with severe COVID-19 associated pneumonia, with study locations in the US, Canada and Europe.
Tocilizumab is a powerful immunosuppressive with the potential for serious adverse reactions, such as infection which can lead to death in some patients, gastric perforation and hepatotoxicity. A range of common side effects can occur with use ranging from upper respiratory tract infection to headache. The drug is approved by the FDA for the treatment of severe or life-threatening cytokine-release syndrome caused by chimeric antigen receptor T-cell therapy. Also, additional FDA-approved indications include rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis and systematic juvenile idiopathic arthritis.