Sarilumab treatment of hospitalised patients with severe or critical COVID-19: a multinational, randomised, adaptive, phase 3, double-blind, placebo-controlled trial

https://www.medrxiv.org/content/10.1101/2021.02.01.21250769v1

NCT04327388- Between March 28 and July 3, 2020, 420 patients were randomised; 416 received treatment (placebo, n=84; sarilumab 200 mg, n=159; sarilumab 400 mg, n=173). At day 29, there were no significant differences in median (95% CI) time to >=2-point improvement between placebo (12.0 [9.0-15.0] days) and sarilumab groups (200 mg: 10.0 [9.0-12.0] days, p=0.96, log-rank test; 400 mg: 10.0 [9.0-13.0] days, p=0.34) or in proportions of patients alive (placebo, 91.7%; sarilumab 200 mg, 89.9%, p=0.63; sarilumab 400 mg, 91.9%, p=0.85). At day 29, there were numerical, nonsignificant survival differences between sarilumab 400 mg (88%) and placebo (79%; difference +9%, 95% CI −7.7 to 25.5, p=0.25) for critical patients. There were no unexpected safety signals. Interpretation: This trial did not demonstrate efficacy of sarilumab in patients hospitalised with COVID-19 and receiving supplemental oxygen. Adequately powered trials of targeted immunomodulatory therapies assessing survival as a primary endpoint are suggested in patients with critical COVID-19.

Tags: