A Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19

Exclusion Criteria

• •1. Critical COVID-19. Subjects meeting any of the following:
• •* Respiratory failure and requiring invasive mechanical ventilation (tracheal intubation)
• •* Septic shock
• •* Multiple organ failure
• •2. Life expectancy \< 24h, in the opinion of the investigator,
• •3. Unlikely to remain at the investigational site beyond 48 hours
• •4. Use of other monoclonal antibodies for COVID-19 treatment
• •5. Current treatment with immunosuppressive agents (including corticosteroids)
• •6. Participating in other drug clinical trials at the IC date or within 60 days after randomization (participation in COVID-19 anti-viral trials may be permitted if approved by Sponsor)
• •7. Laboratory values:
• •* ALT / AST \> 10 ULN at screening
• •* Platelets \< 50х109/l at screening
• •* Absolute Neutrophil Count \< 1х109/l at screening
• •8. Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
• •9. Confirmed active tuberculosis
• •10. History of allergic reaction to monoclonal antibodies
• •11. Pregnancy or breastfeeding
• •12. Any illness or laboratory findings that, in the opinion of the study investigator, might pose an additional risk to the patient by their participation in the study,