#SNY announced that the global Phase 3 trial investigating intravenously administered Kevzara® (sarilumab) at a dose of 200 mg or 400 mga in severely or critically ill patients hospitalized with COVID-19 did not meet its primary endpoint and key secondary endpoint when Kevzara was compared to placebo added to usual hospital care. -
Although not statistically significant, numerical trends were observed toward a decrease in duration of hospital stay as well as an acceleration in time to improve clinical outcomes, as measured by a 2-point improvement from baseline on the 7-point scale.
Further, a trend was observed towards reduced mortality in the critical patient group which was not seen in the severe patient group.
Finally, the time to discharge was shortened by 2-3 days (statistically non-significant) in the patients treated with Kevzara within the first two weeks of treatment.
Serious adverse events were experienced by 26-29% of Kevzara patients and 24% of placebo patients. The incidence of adverse events leading to death was approximately 10% in all three treatment arms. Serious infections (including COVID-19 pneumonia) were observed in 11-13% of Kevzara patients and 12% of placebo patients.
See details regarding SNY's press release.