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

subjects will be excluded from the study if they meet any of the following criteria: 1. patients considered unsalvageable or expected to expire within 24 hours 2. on mechanical ventilation or imminent need for mechanical ventilation expected in the next 24 hours 3. evidence of acute end-organ injury in 2 or more organ systems (not including cardiac or pulmonary), such as, renal, hepatic, or cns injury 4. receiving another investigational therapy for treatment or prevention of covid-19-related hypoxemic respiratory failure or ards other than antiviral therapy 5. systolic blood pressure (sbp) \< 95 mmhg and/or diastolic blood pressure (dbp) \< 50 mmhg or overt symptomatic hypotension during screening 6. resting heart rate \> 110 bpm (beats per minute) during screening 7. severe chronic renal failure as measured by the estimated glomerular filtration rate (egfr) of \< 30 ml/min/1.73m2 using the local laboratory calculation of egfr. 8. significant liver dysfunction as measured by any one of the following at screening: * alt (alanine transaminase) \> 3.0 times uln (upper limit of normal) * ast (aspartate transaminase) \> 3.0 times uln * serum bilirubin ≥ 1.6 mg/dl 9. any in-patient surgical procedure or hospitalization (defined as \> 23 hours) within 30 days of subject screening except for prior hospitalization for covid-19 10. known hypersensitivity to study drug or any of the excipients of the drug formulation 11. pregnant or lactating female subjects 12. any other condition which, in the opinion of the investigator, would place the subject at increased risk or would preclude obtaining informed consent or confound the objectives of study

subjects will be excluded from the study if they meet any of the following criteria: 1. patients considered unsalvageable or expected to expire within 24 hours 2. on mechanical ventilation or imminent need for mechanical ventilation expected in the next 24 hours 3. evidence of acute end-organ injury in 2 or more organ systems (not including cardiac or pulmonary), such as, renal, hepatic, or cns injury 4. receiving another investigational therapy for treatment or prevention of covid-19-related hypoxemic respiratory failure or ards other than antiviral therapy 5. systolic blood pressure (sbp) \< 95 mmhg and/or diastolic blood pressure (dbp) \< 50 mmhg or overt symptomatic hypotension during screening 6. resting heart rate \> 110 bpm (beats per minute) during screening 7. severe chronic renal failure as measured by the estimated glomerular filtration rate (egfr) of \< 30 ml/min/1.73m2 using the local laboratory calculation of egfr. 8. significant liver dysfunction as measured by any one of the following at screening: * alt (alanine transaminase) \> 3.0 times uln (upper limit of normal) * ast (aspartate transaminase) \> 3.0 times uln * serum bilirubin ≥ 1.6 mg/dl 9. any in-patient surgical procedure or hospitalization (defined as \> 23 hours) within 30 days of subject screening except for prior hospitalization for covid-19 10. known hypersensitivity to study drug or any of the excipients of the drug formulation 11. pregnant or lactating female subjects 12. any other condition which, in the opinion of the investigator, would place the subject at increased risk or would preclude obtaining informed consent or confound the objectives of study

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

subjects will be excluded from the study if they meet any of the following criteria: patients considered unsalvageable or expected to expire within 24 hours on mechanical ventilation or imminent need for mechanical ventilation expected in the next 24 hours evidence of acute end-organ injury in 2 or more organ systems (not including cardiac or pulmonary), such as, renal, hepatic, or cns injury receiving another investigational therapy for treatment or prevention of covid-19-related hypoxemic respiratory failure or ards other than antiviral therapy systolic blood pressure (sbp) < 95 mmhg and/or diastolic blood pressure (dbp) < 50 mmhg or overt symptomatic hypotension during screening resting heart rate > 110 bpm (beats per minute) during screening severe chronic renal failure as measured by the estimated glomerular filtration rate (egfr) of < 30 ml/min/1.73m2 using the local laboratory calculation of egfr. significant liver dysfunction as measured by any one of the following at screening: alt (alanine transaminase) > 3.0 times uln (upper limit of normal) ast (aspartate transaminase) > 3.0 times uln serum bilirubin ≥ 1.6 mg/dl any in-patient surgical procedure or hospitalization (defined as > 23 hours) within 30 days of subject screening except for prior hospitalization for covid-19 known hypersensitivity to study drug or any of the excipients of the drug formulation pregnant or lactating female subjects any other condition which, in the opinion of the investigator, would place the subject at increased risk or would preclude obtaining informed consent or confound the objectives of study

subjects will be excluded from the study if they meet any of the following criteria: patients considered unsalvageable or expected to expire within 24 hours on mechanical ventilation or imminent need for mechanical ventilation expected in the next 24 hours evidence of acute end-organ injury in 2 or more organ systems (not including cardiac or pulmonary), such as, renal, hepatic, or cns injury receiving another investigational therapy for treatment or prevention of covid-19-related hypoxemic respiratory failure or ards other than antiviral therapy systolic blood pressure (sbp) < 95 mmhg and/or diastolic blood pressure (dbp) < 50 mmhg or overt symptomatic hypotension during screening resting heart rate > 110 bpm (beats per minute) during screening severe chronic renal failure as measured by the estimated glomerular filtration rate (egfr) of < 30 ml/min/1.73m2 using the local laboratory calculation of egfr. significant liver dysfunction as measured by any one of the following at screening: alt (alanine transaminase) > 3.0 times uln (upper limit of normal) ast (aspartate transaminase) > 3.0 times uln serum bilirubin ≥ 1.6 mg/dl any in-patient surgical procedure or hospitalization (defined as > 23 hours) within 30 days of subject screening except for prior hospitalization for covid-19 known hypersensitivity to study drug or any of the excipients of the drug formulation pregnant or lactating female subjects any other condition which, in the opinion of the investigator, would place the subject at increased risk or would preclude obtaining informed consent or confound the objectives of study

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

subjects will be excluded from the study if they meet any of the following criteria: 1. patients considered unsalvageable or expected to expire within 24 hours 2. on mechanical ventilation or imminent need for mechanical ventilation expected in the next 24 hours 3. evidence of acute end-organ injury in 2 or more organ systems (not including cardiac or pulmonary), such as, renal, hepatic, or cns injury 4. receiving another investigational therapy for treatment or prevention of covid-19-related hypoxemic respiratory failure or ards other than antiviral therapy 5. systolic blood pressure (sbp) < 95 mmhg and/or diastolic blood pressure (dbp) < 50 mmhg or overt symptomatic hypotension during screening 6. resting heart rate > 110 bpm (beats per minute) during screening 7. severe chronic renal failure as measured by the estimated glomerular filtration rate (egfr) of < 30 ml/min/1.73m2 using the local laboratory calculation of egfr. 8. significant liver dysfunction as measured by any one of the following at screening: - alt (alanine transaminase) > 3.0 times uln (upper limit of normal) - ast (aspartate transaminase) > 3.0 times uln - serum bilirubin ≥ 1.6 mg/dl 9. any in-patient surgical procedure or hospitalization (defined as > 23 hours) within 30 days of subject screening except for prior hospitalization for covid-19 10. known hypersensitivity to study drug or any of the excipients of the drug formulation 11. pregnant or lactating female subjects 12. any other condition which, in the opinion of the investigator, would place the subject at increased risk or would preclude obtaining informed consent or confound the objectives of study

subjects will be excluded from the study if they meet any of the following criteria: 1. patients considered unsalvageable or expected to expire within 24 hours 2. on mechanical ventilation or imminent need for mechanical ventilation expected in the next 24 hours 3. evidence of acute end-organ injury in 2 or more organ systems (not including cardiac or pulmonary), such as, renal, hepatic, or cns injury 4. receiving another investigational therapy for treatment or prevention of covid-19-related hypoxemic respiratory failure or ards other than antiviral therapy 5. systolic blood pressure (sbp) < 95 mmhg and/or diastolic blood pressure (dbp) < 50 mmhg or overt symptomatic hypotension during screening 6. resting heart rate > 110 bpm (beats per minute) during screening 7. severe chronic renal failure as measured by the estimated glomerular filtration rate (egfr) of < 30 ml/min/1.73m2 using the local laboratory calculation of egfr. 8. significant liver dysfunction as measured by any one of the following at screening: - alt (alanine transaminase) > 3.0 times uln (upper limit of normal) - ast (aspartate transaminase) > 3.0 times uln - serum bilirubin ≥ 1.6 mg/dl 9. any in-patient surgical procedure or hospitalization (defined as > 23 hours) within 30 days of subject screening except for prior hospitalization for covid-19 10. known hypersensitivity to study drug or any of the excipients of the drug formulation 11. pregnant or lactating female subjects 12. any other condition which, in the opinion of the investigator, would place the subject at increased risk or would preclude obtaining informed consent or confound the objectives of study