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

1. history of hypersensitivity to the investigational treatment or their excipients or to drugs of similar chemical classes 2. suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection with the exception of sars-cov-2 3. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment 4. intubated prior to randomization 5. patients who have explicitly expressed the wish not to receive intensive care support when this would be indicated based on their condition 6. previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of anti-viral therapies or corticosteroids * for covid-19 infection, ongoing corticosteroid treatment is permitted at doses as per local soc * for non-covid-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily or equivalent. 7. serum alanine transaminase (alt) or aspartate transaminase (ast) \>5 times upper limit of normal detected within 24 hours at screening/baseline (according to local laboratory reference ranges) or other evidence of severe hepatic impairment. 8. absolute peripheral blood neutrophil count of ≤1000/mm\^3 9. estimated gfr (egfr) ≤30 ml/min/1.73m\^2 (based on ckd-epi formula) 10. pregnant or breastfeeding, or positive urine or serum pregnancy test in a pre-dose examination 11. any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study 12. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to abstain from any sexual intercourse for a total of 29 days after randomization (the 14-day treatment period plus a 14-day follow-up period). 13. current participation in any other investigational trials, with the exception of (not yet) approved covid-19 therapies that are considered (local) standard of care.

1. history of hypersensitivity to the investigational treatment or their excipients or to drugs of similar chemical classes 2. suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection with the exception of sars-cov-2 3. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment 4. intubated prior to randomization 5. patients who have explicitly expressed the wish not to receive intensive care support when this would be indicated based on their condition 6. previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of anti-viral therapies or corticosteroids * for covid-19 infection, ongoing corticosteroid treatment is permitted at doses as per local soc * for non-covid-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily or equivalent. 7. serum alanine transaminase (alt) or aspartate transaminase (ast) \>5 times upper limit of normal detected within 24 hours at screening/baseline (according to local laboratory reference ranges) or other evidence of severe hepatic impairment. 8. absolute peripheral blood neutrophil count of ≤1000/mm\^3 9. estimated gfr (egfr) ≤30 ml/min/1.73m\^2 (based on ckd-epi formula) 10. pregnant or breastfeeding, or positive urine or serum pregnancy test in a pre-dose examination 11. any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study 12. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to abstain from any sexual intercourse for a total of 29 days after randomization (the 14-day treatment period plus a 14-day follow-up period). 13. current participation in any other investigational trials, with the exception of (not yet) approved covid-19 therapies that are considered (local) standard of care.

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

history of hypersensitivity to the investigational treatment or their excipients or to drugs of similar chemical classes suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection with the exception of sars-cov-2 in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment intubated prior to randomization patients who have explicitly expressed the wish not to receive intensive care support when this would be indicated based on their condition previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of anti-viral therapies or corticosteroids for covid-19 infection, ongoing corticosteroid treatment is permitted at doses as per local soc for non-covid-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily or equivalent. serum alanine transaminase (alt) or aspartate transaminase (ast) >5 times upper limit of normal detected within 24 hours at screening/baseline (according to local laboratory reference ranges) or other evidence of severe hepatic impairment. absolute peripheral blood neutrophil count of ≤1000/mm^3 estimated gfr (egfr) ≤30 ml/min/1.73m^2 (based on ckd-epi formula) pregnant or breastfeeding, or positive urine or serum pregnancy test in a pre-dose examination any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to abstain from any sexual intercourse for a total of 29 days after randomization (the 14-day treatment period plus a 14-day follow-up period). current participation in any other investigational trials, with the exception of (not yet) approved covid-19 therapies that are considered (local) standard of care.

history of hypersensitivity to the investigational treatment or their excipients or to drugs of similar chemical classes suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection with the exception of sars-cov-2 in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment intubated prior to randomization patients who have explicitly expressed the wish not to receive intensive care support when this would be indicated based on their condition previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of anti-viral therapies or corticosteroids for covid-19 infection, ongoing corticosteroid treatment is permitted at doses as per local soc for non-covid-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily or equivalent. serum alanine transaminase (alt) or aspartate transaminase (ast) >5 times upper limit of normal detected within 24 hours at screening/baseline (according to local laboratory reference ranges) or other evidence of severe hepatic impairment. absolute peripheral blood neutrophil count of ≤1000/mm^3 estimated gfr (egfr) ≤30 ml/min/1.73m^2 (based on ckd-epi formula) pregnant or breastfeeding, or positive urine or serum pregnancy test in a pre-dose examination any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to abstain from any sexual intercourse for a total of 29 days after randomization (the 14-day treatment period plus a 14-day follow-up period). current participation in any other investigational trials, with the exception of (not yet) approved covid-19 therapies that are considered (local) standard of care.

Nov. 4, 2020, 11:31 p.m. usa

1. history of hypersensitivity to the investigational treatment or their excipients or to drugs of similar chemical classes 2. suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection with the exception of sars-cov-2 3. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment 4. intubated prior to randomization 5. patients who have explicitly expressed the wish not to receive intensive care support when this would be indicated based on their condition 6. previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of anti-viral therapies or corticosteroids - for covid-19 infection, ongoing corticosteroid treatment is permitted at doses as per local soc - for non-covid-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily or equivalent. 7. serum alanine transaminase (alt) or aspartate transaminase (ast) >5 times upper limit of normal detected within 24 hours at screening/baseline (according to local laboratory reference ranges) or other evidence of severe hepatic impairment. 8. absolute peripheral blood neutrophil count of ≤1000/mm^3 9. estimated gfr (egfr) ≤30 ml/min/1.73m^2 (based on ckd-epi formula) 10. pregnant or breastfeeding, or positive urine or serum pregnancy test in a pre-dose examination 11. any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study 12. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to abstain from any sexual intercourse for a total of 29 days after randomization (the 14-day treatment period plus a 14-day follow-up period). 13. current participation in any other investigational trials, with the exception of (not yet) approved covid-19 therapies that are considered (local) standard of care.

1. history of hypersensitivity to the investigational treatment or their excipients or to drugs of similar chemical classes 2. suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection with the exception of sars-cov-2 3. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment 4. intubated prior to randomization 5. patients who have explicitly expressed the wish not to receive intensive care support when this would be indicated based on their condition 6. previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of anti-viral therapies or corticosteroids - for covid-19 infection, ongoing corticosteroid treatment is permitted at doses as per local soc - for non-covid-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily or equivalent. 7. serum alanine transaminase (alt) or aspartate transaminase (ast) >5 times upper limit of normal detected within 24 hours at screening/baseline (according to local laboratory reference ranges) or other evidence of severe hepatic impairment. 8. absolute peripheral blood neutrophil count of ≤1000/mm^3 9. estimated gfr (egfr) ≤30 ml/min/1.73m^2 (based on ckd-epi formula) 10. pregnant or breastfeeding, or positive urine or serum pregnancy test in a pre-dose examination 11. any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study 12. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to abstain from any sexual intercourse for a total of 29 days after randomization (the 14-day treatment period plus a 14-day follow-up period). 13. current participation in any other investigational trials, with the exception of (not yet) approved covid-19 therapies that are considered (local) standard of care.

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

1. history of hypersensitivity to the investigational treatment or their excipients or to drugs of similar chemical classes 2. suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection (besides sars-cov-2) 3. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment 4. intubated prior to randomization 5. patients who have explicitly expressed the wish not to receive intensive care support when this would be indicated based on their condition 6. previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of hydroxychloroquine, chloroquine or corticosteroids at doses up to and including prednisolone 10 mg daily (or equivalent for non covid-19 disorders) 7. serum alanine transaminase (alt) or aspartate transaminase (ast) >5 times upper limit of normal detected within 24 hours at screening/baseline (according to local laboratory reference ranges) or other evidence of severe hepatic impairment (child-pugh class c) 8. absolute peripheral blood neutrophil count of ≤1000/mm3 9. estimated gfr (egfr) ≤30 ml/min/1.73m2 (based on ckd-epi formula) 10. pregnant or breastfeeding, or positive urine or serum pregnancy test in a pre-dose examination 11. any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study 12. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to abstain from any sexual intercourse for a total of 29 days after randomization (the 14-day treatment period plus a 14-day follow-up period).

1. history of hypersensitivity to the investigational treatment or their excipients or to drugs of similar chemical classes 2. suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection (besides sars-cov-2) 3. in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment 4. intubated prior to randomization 5. patients who have explicitly expressed the wish not to receive intensive care support when this would be indicated based on their condition 6. previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of hydroxychloroquine, chloroquine or corticosteroids at doses up to and including prednisolone 10 mg daily (or equivalent for non covid-19 disorders) 7. serum alanine transaminase (alt) or aspartate transaminase (ast) >5 times upper limit of normal detected within 24 hours at screening/baseline (according to local laboratory reference ranges) or other evidence of severe hepatic impairment (child-pugh class c) 8. absolute peripheral blood neutrophil count of ≤1000/mm3 9. estimated gfr (egfr) ≤30 ml/min/1.73m2 (based on ckd-epi formula) 10. pregnant or breastfeeding, or positive urine or serum pregnancy test in a pre-dose examination 11. any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study 12. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to abstain from any sexual intercourse for a total of 29 days after randomization (the 14-day treatment period plus a 14-day follow-up period).