Trial Underway to Test Efficacy of Sarilumab for Patients with Severe COVID-19
MARCH 17, 2020
John Reed, MD, PhD
A new clinical trial program from Sanofi and Regeneron will evaluate the efficacy of sarilumab (Kevzara), typically used for rheumatoid arthritis, in patients hospitalized with severe coronavirus (COVID-19) infection.
Sarilumab is a monoclonal antibody that works by inhibiting the interleukin-6 (IL-6) pathway through binding and blocking the IL-6 receptor. Currently, it is used for patients who have received a disease-modifying antirheumatic drug that did not work or was not well tolerated.
Investigators hypothesize that IL-6 may drive the inflammatory response within the lungs of patients who are critically ill with COVID-19, investigators hypothesize.
The role of IL-6 has been supported in preliminary results from a single-arm study occurring in China that is using another IL-6 receptor antibody.
The United States-based trial will begin at medical centers in New York, where a large number of COVID-19 cases have occurred in the US outbreak. The trial investigators will evaluate the safety and efficacy of adding sarilumab along with supportive care in comparison with supportive care and placebo.
The study will be a multicenter, double-blind, phase 2/3 trial with 2 parts that seeks to enroll 400 patients. Patients are required to be hospitalized with laboratory confirmed COVID-19 that is classified as severe. Patients who are suffering from multiorgan dysfunction are also eligible. All patients must have pneumonia and fever.
Part 1, which is the phase 2 part of the study, will recruit individuals with severe COVID-19 infection from 16 US sites. Patients will be randomized into 3 groups: high dose, low dose, and placebo. The primary end point is reduction of fever and the secondary end point is a decrease in need for supplemental oxygen.
The second part of the study, which is the phase 3 element, will evaluate if sarilumab use results in longer-term outcomes such as preventing death and reducing the need for ventilation, supplemental oxygen, and/or hospitalization.
“Scientific evidence has emerged to suggest that Kevzara may be a potentially important treatment option for some patients, and this trial will provide the well-controlled, rigorous scientific data we need to determine if IL-6 inhibition with Kevzara is better than current supportive care alone,” John Reed, MD, PhD, global head of research and development at Sanofi said in the announcement. “Additionally, we expect to rapidly initiate trials outside the US in the coming weeks, including areas most affected by the pandemic such as Italy."
The announcement notes that Regeneron will lead the United States based trials and Sanofi will lead the upcoming trials taking place outside of the United States.