NCT04315298
Trial name or title	Evaluation of the efficacy and safety of sarilumab in hospitalized patients With COVID‐19
Methods	RCT, placebo‐controlled, double‐blind study Date of study: March 2020 Location: USA Phase 2/3
Participants	Randomised: 1912 participants Inclusion criteria Laboratory‐confirmed SARS‐CoV‐2 infection as determined by polymerase chain reaction (PCR), result from any specimen (or other commercial or public health assay) within 2 weeks prior to randomisation and no alternative explanation for current clinical condition Hospitalised with illness of any duration with evidence of pneumonia, requires supplemental oxygen and/or assisted ventilation and meets one of the following: Phase 2 and phase 3 cohort 1: meets 1 of the following criteria at baseline: severe disease or critical disease or multi‐system organ dysfunction or immunocompromised Phase 3 cohort 2: patients must be receiving mechanical ventilation to treat respiratory failure due to COVID‐19: ability to provide informed consent signed by study patient or legally acceptable representative willingness and ability to comply with study‐related procedures/assessments Exclusion criteria In the opinion of the investigator, not expected to survive for more than 48 hours from screening Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 2000 mm3; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN); platelets <50,000 per mm3. Treatment with anti‐IL 6, anti‐IL‐6R antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period Current treatment with the simultaneous combination of leflunomide and methotrexate Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections Participation in a double‐blind clinical research study evaluating an investigational product (IP) or therapy within 3 months and less than 5 half‐lives of IP prior to the screening visit. (The use of remdesivir, hydroxychloroquine, or other treatments being used for COVID‐19 treatments in the context of an open‐label study, emergency use authorisation (EUA), compassionate use protocol or open‐label use is permitted) Any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study Known systemic hypersensitivity to sarilumab or the excipients of the drug product Phase 3 cohort 2 only Known or suspected history of immunosuppression or immunodeficiency disorder Patients who require renal replacement therapy for acute kidney injury at randomisation or who required renal replacement therapy within 72 hours prior to randomisation Patients who have circulatory shock requiring vasopressors at randomisation or within 24 hours prior to randomisation Use of extracorporeal life support (e.g. ECMO) or, in the opinion of the investigator, there is a high likelihood that extracorporeal life support will be initiated within 48 hours after randomisation
Interventions	Intervention: sarilumab (low, mild or high dose, dosage not stated) Control interventions: placebo
Outcomes	Primary outcome Proportion of patients with at least 1‐point improvement in clinical status (day 4) Secondary outcomes Time to improvement (up to day 29) Number of patients requiring initiation of mechanical ventilation (up to day 29) Number of patients requiring non‐invasive ventilation Number of deaths (up to day 29)
Starting date	Study start date: 18 March 2020 Study completion date: 2 September 2020
Contact information	Regeneron Pharmaceuticals
Notes	Completed