• In the opinion of the investigator, not expected to survive for more than 48 hoursfrom screening
• Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count <2000 mm3, aspartate aminotransferase or alanine aminotransferase >5x upper limit of normal, 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
• Exclusion criteria related to tuberculosis (TB)a. Known active TB or a history of incompletely treated TB b. Suspected or known extrapulmonary TB
• Patients with suspected or known active systemic bacterial or fungal infections Note: Patients with a history of positive bacterial or fungal cultures but on enrollment do not have suspected or known active systemic bacterial or fungal infections may be enrolled
• Participation in a double-blind clinical research study evaluating an investigational product or therapy within 3 months and less than 5 half-lives of investigational product prior to the screening visit Exception: The use of remdesivir, hydroxychloroquine, or other treatments being used for COVID-19 treatments in the context of an open-label study, emergency use authorization, 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

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Yes