Created at Source Raw Value Validated value
Feb. 28, 2022, 8:29 p.m. eu

1. Need of mechanical pulmonary ventilation (invasive / non-invasive) at study entry, 2. Need of ECMO at study entry, 3. Known hypersensitivity to the active substance or excipients, 4. Pregnancy and breast-feeding, 5. Patients with ongoing uncontrolled cardiac, metabolic, endocrinological, hepatic, renal, neurological or psychiatric illness, in whom participation in a clinical trial could pose an additional risk according to the investigator’s assessment, 6. Positive result on HIV, hepatitis A, B or C at screening, 7. Active tuberculosis infection at screening, 8. Known bacterial or fungal infection at screening, 9. Participation in another interventional treatment study with an investigational product within 30 days, or 5 half-lives, whichever is longer, prior to the planned first study treatment administration or use of other investigational product during this study, 10. Presence of hematological or generalized solid malignancy, 11. Presence of pulmonary embolism, 12. Hepatic impairment assessed individually by the investigator, ALT and/or AST levels ≥ 5x ULN at screening and baseline, 13. On active therapy with IL-6R / IL-6 / JAK / IL-1R / IL-1 inhibitor, 14. Previous receipt of IL-6R / IL-6 / JAK / IL-1R / IL-1 targeted therapy within 30 days, or 5 half-lives, whichever is longer, prior to the planned first study treatment administration, 15. Treatment with convalescent plasma, 16. Absolute Neutrophil Count (ANC) less than 500/µl at screening and baseline, 17. Platelet count of less than 50 000/µl at screening and baseline, 18. History of any severe allergy affecting respiratory system, 19. Previous participation in this study.

1. Need of mechanical pulmonary ventilation (invasive / non-invasive) at study entry, 2. Need of ECMO at study entry, 3. Known hypersensitivity to the active substance or excipients, 4. Pregnancy and breast-feeding, 5. Patients with ongoing uncontrolled cardiac, metabolic, endocrinological, hepatic, renal, neurological or psychiatric illness, in whom participation in a clinical trial could pose an additional risk according to the investigator’s assessment, 6. Positive result on HIV, hepatitis A, B or C at screening, 7. Active tuberculosis infection at screening, 8. Known bacterial or fungal infection at screening, 9. Participation in another interventional treatment study with an investigational product within 30 days, or 5 half-lives, whichever is longer, prior to the planned first study treatment administration or use of other investigational product during this study, 10. Presence of hematological or generalized solid malignancy, 11. Presence of pulmonary embolism, 12. Hepatic impairment assessed individually by the investigator, ALT and/or AST levels ≥ 5x ULN at screening and baseline, 13. On active therapy with IL-6R / IL-6 / JAK / IL-1R / IL-1 inhibitor, 14. Previous receipt of IL-6R / IL-6 / JAK / IL-1R / IL-1 targeted therapy within 30 days, or 5 half-lives, whichever is longer, prior to the planned first study treatment administration, 15. Treatment with convalescent plasma, 16. Absolute Neutrophil Count (ANC) less than 500/µl at screening and baseline, 17. Platelet count of less than 50 000/µl at screening and baseline, 18. History of any severe allergy affecting respiratory system, 19. Previous participation in this study.