Sanofi and Regeneron Pharmaceuticals have reported that a Phase III clinical trial of rheumatoid arthritis drug Kevzara (sarilumab) failed to meet its primary and key secondary endpoints in Covid-19 patients who required mechanical ventilation in the US.
The study compared 400mg dose of the drug plus best supportive care to best supportive care alone.
Minor positive trends were demonstrated in the primary pre-specified analysis group but did not achieve statistical significance. Also, these trends were countered by negative trends in a subgroup of critical patients who were not on mechanical ventilation at baseline.
In the primary analysis arm, adverse events were reported in 80% of patients treated with Kevzara and 77% of those on placebo.
Serious adverse events in at least 3% of patients, more frequent among Kevzara patients, were multi-organ dysfunction syndrome and hypotension.
Based on the data, the companies have halted this US-based trial, including a second cohort of patients who were on a higher 800mg dose of the drug.
The primary analysis involved 194 patients who were critically ill and were on mechanical ventilation at the time of enrolment.