The “COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality,” Roche said.
“In addition, the key secondary endpoints, which included the difference in patient mortality at week four, were not met.
“However, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra”.
The news is a blow for Roche.
The admission of the drug failure followed an Italian study which showed the rheumatoid arthritis drug failed to help patients with early stage COVID-19 pneumonia.
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Roche has boosted its production from several hundred thousand doses to more than a million, in hopes that it would be able to quickly supply the medicine should the trials show positive results.
“People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four.
“We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in COVID-19 associated pneumonia,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.
““We are grateful for the patients and physicians around the world who helped us to complete this study quickly during a public health crisis, while upholding the highest standards of scientific rigour. We will keep working to help combat the COVID-19 pandemic.”
The COVACTA 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 hospitalised 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, randomised, double-blind, placebo-controlled phase III study to investigate Actemra/RoActemra in adult patients hospitalised with severe COVID-19 associated pneumonia, with study locations in the US, Canada and Europe.
Read the full statement by Roche
AFP