The company, which is a subsidiary of Roche, will evaluate the safety and efficacy of Actemra given intravenously plus standard of care in hospitalised adults with severe COVID-19 pneumonia. The combination will be pitted against placebo plus standard of care in what will be a phase 3 trial.
As per the approval from the US Food & Drug Administration (FDA), Genentech will carry out a randomised, double-blind, placebo-controlled trial in collaboration with the US Biomedical Advanced Research and Development Authority (BARDA).
The primary and secondary endpoints of the COVACTA trial include clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) variables.
Patients involved in the COVACTA clinical trial will be checked for 60 days post-randomisation, and an interim analysis will be undertaken to seek early evidence of efficacy, said the Roche subsidiary.
Actemra, which is a humanized interleukin-6 (IL-6) receptor antagonist, was approved by the regulator for the treatment of moderately to severely active rheumatoid arthritis in adults who used one or more disease-modifying antirheumatic drugs (DMARDs) like methotrexate (MTX) but could not get enough relief.
Genentech CEO Alexander Hardy said: “We thank the FDA for rapidly expediting the approval of this clinical trial to evaluate Actemra in critically ill patients suffering from pneumonia following coronavirus infection and we’re moving forward to enroll as quickly as possible.
“Conducting this clinical trial in partnership with BARDA and providing Actemra to support the national stockpile, through the efforts of Secretary Azar and HHS, are important examples of how the U.S. government, the biotechnology industry and healthcare communities are working together in response to this public health crisis.”
Apart from announcing the approval of the COVACTA trial, Genentech said that it will offer 10,000 vials of Actemra to the US Strategic National Stockpile for potential future use as per the US Department of Health and Human Services’ direction.
The Roche subsidiary said that multiple independent trials have been initiated across the world to study the efficacy and safety of Actemra as a potential treatment of COVID-19 pneumonia.
The company claims that the COVACTA trial will be highly important as there are no well-controlled studies and limited published evidence on the safety or efficacy of its rheumatoid arthritis drug in the treatment of patients with COVID-19.