Roche is working with the Food and Drug Administration (FDA) to initiate a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the safety and efficacy of Actemra/RoActemra (tocilizumab) plus standard care in hospitalized adult patients with severe COVID-19 pneumonia, the company said in a news release.
Roche is collaborating with the Biomedical Advanced Research and Development Authority (BARDA), a part of the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR) on the trial.
The study will compare Actemra/RoActemra (tocilizumab) plus standard care to placebo plus standard care.
Roche expects to begin enrolling patients in early April with a target of approximately 330 patients globally, including in the United States. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.
To date, there are several independent clinical trials exploring the efficacy and safety of Actemra/RoActemra for the treatment of patients with COVID-19 pneumonia, according to Roche. Actemra/RoActemra has been included in the 7th updated diagnosis and treatment plan for COVID-19, which was issued by China’s National Health Commission (NHC) on March 3, 2020.
However, Roche said the new trial is vital because there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra/RoActemra in the treatment of patients suffering from COVID-19. In addition, Actemra/RoActemra is not currently approved for this use by any health authorities, including the FDA.
In a separate effort, the World Health Organization (WHO) announced that it is organizing a study in many countries to compare treatments for COVID-19.
Calling it the SOLIDARITY trial, WHO Director-General Tedros Adhanom Ghebreyesus said, “This large, international study is designed to generate the robust data we need, to show which treatments are the most effective.”
So far numerous countries have agreed to participate including Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland and Thailand, he said.
