In the hunt for a COVID-19 treatment, Sanofi and Regeneron have thrown their shared IL-6 inhibitor Kevzara into the global effort. After trumpeting its plan to enroll U.S. patients in a late-stage repurposing trial, the partners have now launched a matching study outside the U.S.
Sanofi and Regeneron have dosed the first patient in the ex-U.S. arm of a global phase 2/3 clinical program evaluating Kevzara as a treatment for severe COVID-19, the partners said Monday.
The Kevzara program will enlist severe or critically ill patients who've been hospitalized in Italy, Spain, Germany, France, Canada and Russia, and the drugmakers are working to "secure initiation at additional sites," Regeneron said in a release.
This second trial will eventually enroll around 300 patients and study intravenous Kevzara as an add-on to supportive care through an "adaptive design," Regeneron said.
Two weeks ago, Sanofi and Regeneron announced the U.S. arm of the program, saying the trial would test Kevzara as an add-on to supportive care in around 400 patients across 16 states.
The first segment of the trial will study Kevzara's effects on fever and patients’ need for supplemental oxygen, while a second segment will focus on longer-term outcomes, including preventing death and cutting the need for supportive care such as mechanical ventilation, supplemental oxygen and/or hospitalization, the partners said.