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

1. as a result of the medical review and screening investigation, the principal investigator considers the patient unfit for the study and/or progression to death is imminent and inevitable irrespective of the provision of treatments. 2. clinical diagnosis of respiratory failure requiring ecmo and/or therapy is not available due to limitation. 3. shock defined by systolic blood pressure \<90 mm hg, or diastolic blood pressure \<60 mm hg or requiring vasopressors. 4. multi-organ dysfunction/failure. 5. patient has severe chronic obstructive or restrictive pulmonary disease (copd) (as defined by prior pulmonary function tests), chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.). 6. patient has chronic conditions requiring chemotherapy or immunosuppressive medication. 7. a history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin (n- acetyltryptophan, sodium caprylate). 8. prolonged qt interval. 9. patient has known pregnancy or is currently breastfeeding. 10. patient planning to become pregnant, or father a child, during the treatment and follow-up period and/or is not willing to remain abstinent or use contraception. 11. participation in another clinical trial (not including treatments for covid-19 as approved by the fda through expanded access, emergency, or compassionate use), or participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s).

1. as a result of the medical review and screening investigation, the principal investigator considers the patient unfit for the study and/or progression to death is imminent and inevitable irrespective of the provision of treatments. 2. clinical diagnosis of respiratory failure requiring ecmo and/or therapy is not available due to limitation. 3. shock defined by systolic blood pressure \<90 mm hg, or diastolic blood pressure \<60 mm hg or requiring vasopressors. 4. multi-organ dysfunction/failure. 5. patient has severe chronic obstructive or restrictive pulmonary disease (copd) (as defined by prior pulmonary function tests), chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.). 6. patient has chronic conditions requiring chemotherapy or immunosuppressive medication. 7. a history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin (n- acetyltryptophan, sodium caprylate). 8. prolonged qt interval. 9. patient has known pregnancy or is currently breastfeeding. 10. patient planning to become pregnant, or father a child, during the treatment and follow-up period and/or is not willing to remain abstinent or use contraception. 11. participation in another clinical trial (not including treatments for covid-19 as approved by the fda through expanded access, emergency, or compassionate use), or participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s).

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

as a result of the medical review and screening investigation, the principal investigator considers the patient unfit for the study and/or progression to death is imminent and inevitable irrespective of the provision of treatments. clinical diagnosis of respiratory failure requiring ecmo and/or therapy is not available due to limitation. shock defined by systolic blood pressure <90 mm hg, or diastolic blood pressure <60 mm hg or requiring vasopressors. multi-organ dysfunction/failure. patient has severe chronic obstructive or restrictive pulmonary disease (copd) (as defined by prior pulmonary function tests), chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.). patient has chronic conditions requiring chemotherapy or immunosuppressive medication. a history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin (n- acetyltryptophan, sodium caprylate). prolonged qt interval. patient has known pregnancy or is currently breastfeeding. patient planning to become pregnant, or father a child, during the treatment and follow-up period and/or is not willing to remain abstinent or use contraception. participation in another clinical trial (not including treatments for covid-19 as approved by the fda through expanded access, emergency, or compassionate use), or participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s).

as a result of the medical review and screening investigation, the principal investigator considers the patient unfit for the study and/or progression to death is imminent and inevitable irrespective of the provision of treatments. clinical diagnosis of respiratory failure requiring ecmo and/or therapy is not available due to limitation. shock defined by systolic blood pressure <90 mm hg, or diastolic blood pressure <60 mm hg or requiring vasopressors. multi-organ dysfunction/failure. patient has severe chronic obstructive or restrictive pulmonary disease (copd) (as defined by prior pulmonary function tests), chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.). patient has chronic conditions requiring chemotherapy or immunosuppressive medication. a history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin (n- acetyltryptophan, sodium caprylate). prolonged qt interval. patient has known pregnancy or is currently breastfeeding. patient planning to become pregnant, or father a child, during the treatment and follow-up period and/or is not willing to remain abstinent or use contraception. participation in another clinical trial (not including treatments for covid-19 as approved by the fda through expanded access, emergency, or compassionate use), or participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s).

May 5, 2021, 11:25 a.m. usa

1. as a result of the medical review and screening investigation, the principal investigator considers the patient unfit for the study and/or progression to death is imminent and inevitable irrespective of the provision of treatments. 2. clinical diagnosis of respiratory failure requiring ecmo and/or therapy is not available due to limitation. 3. shock defined by systolic blood pressure <90 mm hg, or diastolic blood pressure <60 mm hg or requiring vasopressors. 4. multi-organ dysfunction/failure. 5. patient has severe chronic obstructive or restrictive pulmonary disease (copd) (as defined by prior pulmonary function tests), chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.). 6. patient has chronic conditions requiring chemotherapy or immunosuppressive medication. 7. a history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin (n- acetyltryptophan, sodium caprylate). 8. prolonged qt interval. 9. patient has known pregnancy or is currently breastfeeding. 10. patient planning to become pregnant, or father a child, during the treatment and follow-up period and/or is not willing to remain abstinent or use contraception. 11. participation in another clinical trial (not including treatments for covid-19 as approved by the fda through expanded access, emergency, or compassionate use), or participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s).

1. as a result of the medical review and screening investigation, the principal investigator considers the patient unfit for the study and/or progression to death is imminent and inevitable irrespective of the provision of treatments. 2. clinical diagnosis of respiratory failure requiring ecmo and/or therapy is not available due to limitation. 3. shock defined by systolic blood pressure <90 mm hg, or diastolic blood pressure <60 mm hg or requiring vasopressors. 4. multi-organ dysfunction/failure. 5. patient has severe chronic obstructive or restrictive pulmonary disease (copd) (as defined by prior pulmonary function tests), chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.). 6. patient has chronic conditions requiring chemotherapy or immunosuppressive medication. 7. a history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin (n- acetyltryptophan, sodium caprylate). 8. prolonged qt interval. 9. patient has known pregnancy or is currently breastfeeding. 10. patient planning to become pregnant, or father a child, during the treatment and follow-up period and/or is not willing to remain abstinent or use contraception. 11. participation in another clinical trial (not including treatments for covid-19 as approved by the fda through expanded access, emergency, or compassionate use), or participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s).