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

1. tube feeding or parenteral nutrition. 2. respiratory decompensation requiring mechanical ventilation. 3. pregnant or lactating women. 4. any condition which, in the opinion of the principal investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints (for examples social condition other non-related medical illness). 5. known to have severe allergic reactions to one of the study drug components. 6. active tuberculosis (tb) infection. 7. subjects diagnosed to suffer from concomitant active infection: bacterial, fungal, viral, or other infection cause besides covid-19. 8. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24-36 hours, irrespective of the provision of treatments. 9. treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months (steroids are permitted). 10. participating in other drug clinical trial. 11. estimated glomerular filtration rate (egfr) \< 30 ml/min (including patients receiving hemodialysis or hemofiltration). 12. alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 5 x upper limit of normal (uln) detected within 24 hours of screening (according to local laboratory reference ranges). 13. absolute neutrophil count (anc) \< 1000/ul at screening. 14. platelet count \< 50,000/ul at screening. 15. body weight \< 40 kg or \>120 kg. 16. treatment with other investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization.

1. tube feeding or parenteral nutrition. 2. respiratory decompensation requiring mechanical ventilation. 3. pregnant or lactating women. 4. any condition which, in the opinion of the principal investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints (for examples social condition other non-related medical illness). 5. known to have severe allergic reactions to one of the study drug components. 6. active tuberculosis (tb) infection. 7. subjects diagnosed to suffer from concomitant active infection: bacterial, fungal, viral, or other infection cause besides covid-19. 8. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24-36 hours, irrespective of the provision of treatments. 9. treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months (steroids are permitted). 10. participating in other drug clinical trial. 11. estimated glomerular filtration rate (egfr) \< 30 ml/min (including patients receiving hemodialysis or hemofiltration). 12. alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 5 x upper limit of normal (uln) detected within 24 hours of screening (according to local laboratory reference ranges). 13. absolute neutrophil count (anc) \< 1000/ul at screening. 14. platelet count \< 50,000/ul at screening. 15. body weight \< 40 kg or \>120 kg. 16. treatment with other investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization.

Feb. 8, 2022, 2:30 p.m. usa

tube feeding or parenteral nutrition. respiratory decompensation requiring mechanical ventilation. pregnant or lactating women. any condition which, in the opinion of the principal investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints (for examples social condition other non-related medical illness). known to have severe allergic reactions to one of the study drug components. active tuberculosis (tb) infection. subjects diagnosed to suffer from concomitant active infection: bacterial, fungal, viral, or other infection cause besides covid-19. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24-36 hours, irrespective of the provision of treatments. treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months (steroids are permitted). participating in other drug clinical trial. estimated glomerular filtration rate (egfr) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 x upper limit of normal (uln) detected within 24 hours of screening (according to local laboratory reference ranges). absolute neutrophil count (anc) < 1000/ul at screening. platelet count < 50,000/ul at screening. body weight < 40 kg or >120 kg. treatment with other investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization.

tube feeding or parenteral nutrition. respiratory decompensation requiring mechanical ventilation. pregnant or lactating women. any condition which, in the opinion of the principal investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints (for examples social condition other non-related medical illness). known to have severe allergic reactions to one of the study drug components. active tuberculosis (tb) infection. subjects diagnosed to suffer from concomitant active infection: bacterial, fungal, viral, or other infection cause besides covid-19. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24-36 hours, irrespective of the provision of treatments. treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months (steroids are permitted). participating in other drug clinical trial. estimated glomerular filtration rate (egfr) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 x upper limit of normal (uln) detected within 24 hours of screening (according to local laboratory reference ranges). absolute neutrophil count (anc) < 1000/ul at screening. platelet count < 50,000/ul at screening. body weight < 40 kg or >120 kg. treatment with other investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization.