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

1. concurrent serious medical condition which in the opinion of the investigator constituted a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation 2. known, active tuberculosis, active hepatitis b, c, or human immunodeficiency virus (hiv) infection (i.e., hiv with a cd4 count\<500 cells/mm³). 3. moderate or severe impairment of hepatic function (e.g., child-pugh class b or c where alterations in the score components were not due to another underlying disease (see section 8.4.5 in the protocol)). 4. severe renal impairment (i.e., estimated glomerular filtration rate (egfr)≤30 ml/min/1.73m2) 5. covid-19 symptom onset \>21 days prior to screening (visit 1). 6. hospitalized due to covid-19 for \>72 hours at screening (visit 1). 7. invasive mechanical ventilation or ecmo within 72 hours of screening (visit 1). 8. expected need for invasive mechanical ventilation or ecmo in \<48 hours in the opinion of the investigator 9. moderate to severe ards (e.g., same-day pao2/fio2 ≤200 mmhg; or spo2/fio2 ≤232 if arterial blood gas test is not available), if on non-invasive mechanical ventilation or high-flow oxygen. 10. pregnant or breast-feeding female subjects 11. any previous and concurrent experimental treatment for covid-19 that was not considered local soc. 12. treatment with the medications listed below within 1 week prior to screening (visit 1) or anticipated need for such medication during the participation in this trial: 1. strong cytochrome p450 (cyp) 3a4 inducers. 2. p-glycoprotein (p-gp) substrates with narrow therapeutic index. 3. high dose breast cancer resistance protein (bcrp) sensitive substrates. 4. warfarin. 5. sulphasalazine or rosuvastatin. 13. current or previous participation in any other clinical trial where the subject had received a dose of imp within 1 month or 5 half-lives of the imp, whichever was longest, prior to screening (visit 1). 14. positive pregnancy test (see section 8.4.6 in the protocol). 15. abnormal laboratory value at screening (visit 1) indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator

1. concurrent serious medical condition which in the opinion of the investigator constituted a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation 2. known, active tuberculosis, active hepatitis b, c, or human immunodeficiency virus (hiv) infection (i.e., hiv with a cd4 count\<500 cells/mm³). 3. moderate or severe impairment of hepatic function (e.g., child-pugh class b or c where alterations in the score components were not due to another underlying disease (see section 8.4.5 in the protocol)). 4. severe renal impairment (i.e., estimated glomerular filtration rate (egfr)≤30 ml/min/1.73m2) 5. covid-19 symptom onset \>21 days prior to screening (visit 1). 6. hospitalized due to covid-19 for \>72 hours at screening (visit 1). 7. invasive mechanical ventilation or ecmo within 72 hours of screening (visit 1). 8. expected need for invasive mechanical ventilation or ecmo in \<48 hours in the opinion of the investigator 9. moderate to severe ards (e.g., same-day pao2/fio2 ≤200 mmhg; or spo2/fio2 ≤232 if arterial blood gas test is not available), if on non-invasive mechanical ventilation or high-flow oxygen. 10. pregnant or breast-feeding female subjects 11. any previous and concurrent experimental treatment for covid-19 that was not considered local soc. 12. treatment with the medications listed below within 1 week prior to screening (visit 1) or anticipated need for such medication during the participation in this trial: 1. strong cytochrome p450 (cyp) 3a4 inducers. 2. p-glycoprotein (p-gp) substrates with narrow therapeutic index. 3. high dose breast cancer resistance protein (bcrp) sensitive substrates. 4. warfarin. 5. sulphasalazine or rosuvastatin. 13. current or previous participation in any other clinical trial where the subject had received a dose of imp within 1 month or 5 half-lives of the imp, whichever was longest, prior to screening (visit 1). 14. positive pregnancy test (see section 8.4.6 in the protocol). 15. abnormal laboratory value at screening (visit 1) indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator

Dec. 15, 2023, 4 p.m. usa

concurrent serious medical condition which in the opinion of the investigator constituted a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation known, active tuberculosis, active hepatitis b, c, or human immunodeficiency virus (hiv) infection (i.e., hiv with a cd4 count<500 cells/mm³). moderate or severe impairment of hepatic function (e.g., child-pugh class b or c where alterations in the score components were not due to another underlying disease (see section 8.4.5 in the protocol)). severe renal impairment (i.e., estimated glomerular filtration rate (egfr)≤30 ml/min/1.73m2) covid-19 symptom onset >21 days prior to screening (visit 1). hospitalized due to covid-19 for >72 hours at screening (visit 1). invasive mechanical ventilation or ecmo within 72 hours of screening (visit 1). expected need for invasive mechanical ventilation or ecmo in <48 hours in the opinion of the investigator moderate to severe ards (e.g., same-day pao2/fio2 ≤200 mmhg; or spo2/fio2 ≤232 if arterial blood gas test is not available), if on non-invasive mechanical ventilation or high-flow oxygen. pregnant or breast-feeding female subjects any previous and concurrent experimental treatment for covid-19 that was not considered local soc. treatment with the medications listed below within 1 week prior to screening (visit 1) or anticipated need for such medication during the participation in this trial: strong cytochrome p450 (cyp) 3a4 inducers. p-glycoprotein (p-gp) substrates with narrow therapeutic index. high dose breast cancer resistance protein (bcrp) sensitive substrates. warfarin. sulphasalazine or rosuvastatin. current or previous participation in any other clinical trial where the subject had received a dose of imp within 1 month or 5 half-lives of the imp, whichever was longest, prior to screening (visit 1). positive pregnancy test (see section 8.4.6 in the protocol). abnormal laboratory value at screening (visit 1) indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator

concurrent serious medical condition which in the opinion of the investigator constituted a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation known, active tuberculosis, active hepatitis b, c, or human immunodeficiency virus (hiv) infection (i.e., hiv with a cd4 count<500 cells/mm³). moderate or severe impairment of hepatic function (e.g., child-pugh class b or c where alterations in the score components were not due to another underlying disease (see section 8.4.5 in the protocol)). severe renal impairment (i.e., estimated glomerular filtration rate (egfr)≤30 ml/min/1.73m2) covid-19 symptom onset >21 days prior to screening (visit 1). hospitalized due to covid-19 for >72 hours at screening (visit 1). invasive mechanical ventilation or ecmo within 72 hours of screening (visit 1). expected need for invasive mechanical ventilation or ecmo in <48 hours in the opinion of the investigator moderate to severe ards (e.g., same-day pao2/fio2 ≤200 mmhg; or spo2/fio2 ≤232 if arterial blood gas test is not available), if on non-invasive mechanical ventilation or high-flow oxygen. pregnant or breast-feeding female subjects any previous and concurrent experimental treatment for covid-19 that was not considered local soc. treatment with the medications listed below within 1 week prior to screening (visit 1) or anticipated need for such medication during the participation in this trial: strong cytochrome p450 (cyp) 3a4 inducers. p-glycoprotein (p-gp) substrates with narrow therapeutic index. high dose breast cancer resistance protein (bcrp) sensitive substrates. warfarin. sulphasalazine or rosuvastatin. current or previous participation in any other clinical trial where the subject had received a dose of imp within 1 month or 5 half-lives of the imp, whichever was longest, prior to screening (visit 1). positive pregnancy test (see section 8.4.6 in the protocol). abnormal laboratory value at screening (visit 1) indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator

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

concurrent serious medical condition which in the opinion of the investigator constitutes a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation known, active hepatitis b, c, or human immunodeficiency virus infection (i.e., human immunodeficiency virus (hiv) with a cluster of differentiation 4 (cd4) count <500 cells/mm³) impaired hepatic function (i.e., child-pugh class a or b) severe renal impairment (i.e., estimated glomerular filtration rate (egfr) ≤30 ml/min/1.73 m2) corona virus disease (covid)-19 symptom onset >14 days prior to screening hospitalized due to covid-19 for >72 hours at screening invasive mechanical ventilation or ecmo within 72 hours of screening expected need for invasive mechanical ventilation or ecmo in <48 hours in the opinion of the investigator moderate to severe ards (e.g., partial pressure of oxygen (pao2)/fio2 ≤200 mmhg), if on non-invasive mechanical ventilation or high-flow oxygen pregnant or breast-feeding female subjects any previous and concurrent experimental treatment for covid-19 that is not considered local soc. treatment with the medications listed below within 1 week prior to screening or anticipated need for such medication during the participation in this trial: strong cytochrome p450 (cyp) 3a4 inducers. p-glycoprotein (p-gp) substrates with narrow therapeutic index. high dose breast cancer resistance protein (bcrp) sensitive substrates. warfarin. sulphasalazine or rosuvastatin. current or previous participation in any other clinical trial where the subject has received a dose of imp within 1 month or 5 half-lives of the investigational medicinal product (imp), whichever is longest, prior to screening positive pregnancy test abnormal laboratory value at screening indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator

concurrent serious medical condition which in the opinion of the investigator constitutes a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation known, active hepatitis b, c, or human immunodeficiency virus infection (i.e., human immunodeficiency virus (hiv) with a cluster of differentiation 4 (cd4) count <500 cells/mm³) impaired hepatic function (i.e., child-pugh class a or b) severe renal impairment (i.e., estimated glomerular filtration rate (egfr) ≤30 ml/min/1.73 m2) corona virus disease (covid)-19 symptom onset >14 days prior to screening hospitalized due to covid-19 for >72 hours at screening invasive mechanical ventilation or ecmo within 72 hours of screening expected need for invasive mechanical ventilation or ecmo in <48 hours in the opinion of the investigator moderate to severe ards (e.g., partial pressure of oxygen (pao2)/fio2 ≤200 mmhg), if on non-invasive mechanical ventilation or high-flow oxygen pregnant or breast-feeding female subjects any previous and concurrent experimental treatment for covid-19 that is not considered local soc. treatment with the medications listed below within 1 week prior to screening or anticipated need for such medication during the participation in this trial: strong cytochrome p450 (cyp) 3a4 inducers. p-glycoprotein (p-gp) substrates with narrow therapeutic index. high dose breast cancer resistance protein (bcrp) sensitive substrates. warfarin. sulphasalazine or rosuvastatin. current or previous participation in any other clinical trial where the subject has received a dose of imp within 1 month or 5 half-lives of the investigational medicinal product (imp), whichever is longest, prior to screening positive pregnancy test abnormal laboratory value at screening indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator

May 13, 2021, 12:31 a.m. usa

1. concurrent serious medical condition which in the opinion of the investigator constitutes a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation 2. known, active hepatitis b, c, or human immunodeficiency virus infection (i.e., human immunodeficiency virus (hiv) with a cluster of differentiation 4 (cd4) count <500 cells/mm³) 3. impaired hepatic function (i.e., child-pugh class a or b) 4. severe renal impairment (i.e., estimated glomerular filtration rate (egfr) ≤30 ml/min/1.73 m2) 5. corona virus disease (covid)-19 symptom onset >14 days prior to screening 6. hospitalized due to covid-19 for >72 hours at screening 7. invasive mechanical ventilation or ecmo within 72 hours of screening 8. expected need for invasive mechanical ventilation or ecmo in <48 hours in the opinion of the investigator 9. moderate to severe ards (e.g., partial pressure of oxygen (pao2)/fio2 ≤200 mmhg), if on non-invasive mechanical ventilation or high-flow oxygen 10. pregnant or breast-feeding female subjects 11. any previous and concurrent experimental treatment for covid-19 that is not considered local soc. 12. treatment with the medications listed below within 1 week prior to screening or anticipated need for such medication during the participation in this trial: 1. strong cytochrome p450 (cyp) 3a4 inducers. 2. p-glycoprotein (p-gp) substrates with narrow therapeutic index. 3. high dose breast cancer resistance protein (bcrp) sensitive substrates. 4. warfarin. 5. sulphasalazine or rosuvastatin. 13. current or previous participation in any other clinical trial where the subject has received a dose of imp within 1 month or 5 half-lives of the investigational medicinal product (imp), whichever is longest, prior to screening 14. positive pregnancy test 15. abnormal laboratory value at screening indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator

1. concurrent serious medical condition which in the opinion of the investigator constitutes a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation 2. known, active hepatitis b, c, or human immunodeficiency virus infection (i.e., human immunodeficiency virus (hiv) with a cluster of differentiation 4 (cd4) count <500 cells/mm³) 3. impaired hepatic function (i.e., child-pugh class a or b) 4. severe renal impairment (i.e., estimated glomerular filtration rate (egfr) ≤30 ml/min/1.73 m2) 5. corona virus disease (covid)-19 symptom onset >14 days prior to screening 6. hospitalized due to covid-19 for >72 hours at screening 7. invasive mechanical ventilation or ecmo within 72 hours of screening 8. expected need for invasive mechanical ventilation or ecmo in <48 hours in the opinion of the investigator 9. moderate to severe ards (e.g., partial pressure of oxygen (pao2)/fio2 ≤200 mmhg), if on non-invasive mechanical ventilation or high-flow oxygen 10. pregnant or breast-feeding female subjects 11. any previous and concurrent experimental treatment for covid-19 that is not considered local soc. 12. treatment with the medications listed below within 1 week prior to screening or anticipated need for such medication during the participation in this trial: 1. strong cytochrome p450 (cyp) 3a4 inducers. 2. p-glycoprotein (p-gp) substrates with narrow therapeutic index. 3. high dose breast cancer resistance protein (bcrp) sensitive substrates. 4. warfarin. 5. sulphasalazine or rosuvastatin. 13. current or previous participation in any other clinical trial where the subject has received a dose of imp within 1 month or 5 half-lives of the investigational medicinal product (imp), whichever is longest, prior to screening 14. positive pregnancy test 15. abnormal laboratory value at screening indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator