Regeneron and Sanofi have announced an independent data safety monitoring committee recommended that its Phase II/III study repurposing Kevzara for Covid-19 only continue treating ‘critical’ patients – it had previously also enrolled and treated ‘severe’ patients.
Critical patients are those who require mechanical ventilation, high flow oxygenation or treatment in the intensive care unit, while severe patients are those who required oxygen supplementation without mechanical ventilation or high flow oxygenation.
This is because when severe and critical groups were combined Kevzara had “no notable benefit on clinical outcomes”. Also, analysis identified there were a negative trends for most outcomes in the severe group, compared to positive trends for all outcomes in the critical group, according to a release.
In addition, the committee recommended the discontinuation of the lower, 200mg dose of Kevzara arm of the trial.
Kevzara is already approved for moderately to severely activated rheumatoid arthritis patients who have not responded to prior therapy. It is an interleukin-6 inhibitor; these drugs are believed to have an effect at reducing the cytokine storm associated with severely-ill Covid-19 patients.