sarilumab low dose (200mg) (n=161) vs. placebo (n=86)
randomized controlled trial
Sarilumab
Prefilled syringes (PFS) of sarilumab 200mg solution for subcutaneous injection into a specified volume of 0,9% NaCl solution for IV infusion (one syringe for the 200-mg dose). An option for a second dose existed (within the assigned treatment arm) within 24–48 hours of the first dose, based on the investigator’s benefit-risk assessment.
Placebo
0,9% NaCl solution for IV infusion.
Phase 2/3, 3 arms: Patients were randomised 2:2:1 to intravenous sarilumab 400 mg, sarilumab 200 mg, or placebo.
COVID-19 severe or critically
Patients aged 18 years or older at the time of signing informed consent who had been hospitalised for laboratory-confirmed SARS-CoV-2 infection in any specimenwithin 2 weeks prior to randomisation and with evidence of pneumonia by chest imaging orchest auscultation and no alternative explanation for current clinical presentation. Patientsalso had to meet criteria for severe disease (defined as administration of supplemental oxygenby nasal cannula, simple face mask, or another similar device) or critical disease (defined asneed for supplemental oxygen delivered by nonrebreather mask or high-flow nasal cannula,use of invasive or noninvasive ventilation, or treatment in an intensive care unit).
Double-blind.
45 sites in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Spain.
1—Death; 2—Hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 3—Hospitalised, on noninvasive ventilation or high-flow oxygen devices; 4—Hospitalised, requiring supplemental oxygen; 5—Hospitalised, not requiring supplemental oxygen –requiring ongoing medical care (COVID-19 related or otherwise); 6—Hospitalised, notrequiring supplemental oxygen – no longer requiring ongoing medical care; 7—Not hospitalised.
