The phase 3 trial of sarilumab (Kevzara) for severe COVID-19 has been terminated after it failed to meet primary and key secondary endpoints.
The trial was investigating intravenous sarilumab 200 mg (n=161) or 400 mg (n=173) in severely or critically ill patients hospitalised with COVID-19 compared to placebo (n=86) added to usual hospital care.
There were non-significant numerical trends toward a decrease in duration of hospital stay and acceleration in time to improve clinical outcomes. A trend was also observed towards reduced mortality in the critical patient group which was not seen in the severe patient group. The time to discharge was shortened by 2-3 days in the patients treated with sarilumab within the first two weeks of treatment, but this was not statistically significant.
Serious adverse events were experienced by 26-29 per cent of sarilumab patients and 24 per cent of placebo patients. The incidence of adverse events leading to death was approximately 10 per cent in all three treatment arms. Serious infections, including COVID-19 pneumonia, occurred in 11-13 per cent of sarilumab patients and 12 per cent of placebo patients.
Sanofi and Regeneron say they do not anticipate conducting further clinical studies of sarilumab in COVID-19.