Created at Source Raw Value Validated value
June 25, 2024, noon usa

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,

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,

Nov. 16, 2021, 6:30 p.m. usa

critical covid-19. subjects meeting any of the following: respiratory failure and requiring invasive mechanical ventilation (tracheal intubation) septic shock multiple organ failure life expectancy < 24h, in the opinion of the investigator, unlikely to remain at the investigational site beyond 48 hours use of other monoclonal antibodies for covid-19 treatment current treatment with immunosuppressive agents (including corticosteroids) 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) laboratory values: alt / ast > 10 uln at screening platelets < 50х109/l at screening absolute neutrophil count < 1х109/l at screening suspected active bacterial, fungal, viral, or other infection (besides covid-19) confirmed active tuberculosis history of allergic reaction to monoclonal antibodies pregnancy or breastfeeding 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,

critical covid-19. subjects meeting any of the following: respiratory failure and requiring invasive mechanical ventilation (tracheal intubation) septic shock multiple organ failure life expectancy < 24h, in the opinion of the investigator, unlikely to remain at the investigational site beyond 48 hours use of other monoclonal antibodies for covid-19 treatment current treatment with immunosuppressive agents (including corticosteroids) 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) laboratory values: alt / ast > 10 uln at screening platelets < 50х109/l at screening absolute neutrophil count < 1х109/l at screening suspected active bacterial, fungal, viral, or other infection (besides covid-19) confirmed active tuberculosis history of allergic reaction to monoclonal antibodies pregnancy or breastfeeding 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,

Oct. 26, 2020, 11:31 p.m. usa

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,

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,