The COVACTA trial did not meet its primary end-point of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary end-point of reduced patient mortality, Roche said
New Delhi: The Roche Group on Wednesday said that a clinical trial of its patented drug tocilizumab did not meet its primary and secondary endpoints, respectively, of improving clinical status of patients with covid-19 associated pneumonia and reducing patient mortality.
The study, called COVACTA, is the first global, randomised, double-blind, placebo-controlled phase III trial of the drug. The study on 450 patients across 67 sites in the US was conducted by the company in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), an agency in the US Department of Health and Human Services.
“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, Roche’s chief medical officer and head of global product development, in a statement.
The company, however, said it remains committed to continuing the Actemra clinical trial programme in covid-19 to further explore use of the drug in other treatment settings, including in combination with an antiviral.
The intravenous drug is also sold in India through the company’s licensee Cipla Ltd under the brand Actemra. Cipla has priced the drug at ₹40,500 for a 400 mg vial.
Tocilizumab was included in the Indian health ministry’s clinical management protocol for covid-19 as a drug for ‘off-label’ use—a term that refers to the use of a drug in an emergency for a disease or medical condition that it is not approved to treat.
Click here to read the Mint ePaperLivemint.com is now on Telegram. Join Livemint channel in your Telegram and stay updated
