subjects requiring invasive mechanical ventilation or icu admission or with partial pressure of arterial oxygen/ fraction of inspired oxygen (pao2/fio2) ≤ 150 mmhg (i.e., arterial oxygen in millimeter of mercury (mmhg) divided by fraction inspired oxygen concentration [example, 0.21 for room air]). clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk. the subject has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product, or known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. a medical condition in which the infusion of additional fluid is contraindicated (example, decompensated congestive heart failure or renal failure with fluid overload). this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered not able to be reversed by the principal investigator. known alpha-1 antitrypsin deficiency for which the subject is already receiving alpha1-proteinase inhibitor augmentation therapy. women who are pregnant or breastfeeding. female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline visit. subjects for whom there is limitation of therapeutic effort such as "do not resuscitate" status. currently participating in another interventional clinical trial with investigational medical product or device. subjects previously requiring long-term oxygen therapy (home oxygen therapy). history (within the last 2 years) of myocardial infarction, unstable angina, stroke or transient ischemic attacks, pulmonary embolism or deep venous thrombosis subject has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year systolic blood pressure < 100 mm hg or > 160 mm hg (uncontrolled hypertension) at the time of screening alanine aminotransferase (alt) ≥ 2 times the upper limit of normal (uln) any elevation of total bilirubin at the time of screening estimated glomerular filtration rate (egfr) < 45 ml/min (or subject is dependent on dialysis/renal replacement therapy) at the time of screening hemoglobin < 10 g/dl at the time of screening absolute neutrophil count < 1000/mm3 at the time of screening platelet count < 75,000/mm3 at the time of screening subject has history of drug or alcohol abuse within the past 24 months subject is unwilling to commit to follow-up visits known history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome

subjects requiring invasive mechanical ventilation or icu admission or with partial pressure of arterial oxygen/ fraction of inspired oxygen (pao2/fio2) ≤ 150 mmhg (i.e., arterial oxygen in millimeter of mercury (mmhg) divided by fraction inspired oxygen concentration [example, 0.21 for room air]). clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk. the subject has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product, or known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. a medical condition in which the infusion of additional fluid is contraindicated (example, decompensated congestive heart failure or renal failure with fluid overload). this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered not able to be reversed by the principal investigator. known alpha-1 antitrypsin deficiency for which the subject is already receiving alpha1-proteinase inhibitor augmentation therapy. women who are pregnant or breastfeeding. female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline visit. subjects for whom there is limitation of therapeutic effort such as "do not resuscitate" status. currently participating in another interventional clinical trial with investigational medical product or device. subjects previously requiring long-term oxygen therapy (home oxygen therapy). history (within the last 2 years) of myocardial infarction, unstable angina, stroke or transient ischemic attacks, pulmonary embolism or deep venous thrombosis subject has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year systolic blood pressure < 100 mm hg or > 160 mm hg (uncontrolled hypertension) at the time of screening alanine aminotransferase (alt) ≥ 2 times the upper limit of normal (uln) any elevation of total bilirubin at the time of screening estimated glomerular filtration rate (egfr) < 45 ml/min (or subject is dependent on dialysis/renal replacement therapy) at the time of screening hemoglobin < 10 g/dl at the time of screening absolute neutrophil count < 1000/mm3 at the time of screening platelet count < 75,000/mm3 at the time of screening subject has history of drug or alcohol abuse within the past 24 months subject is unwilling to commit to follow-up visits known history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome

1. subjects requiring invasive mechanical ventilation or icu admission or with partial pressure of arterial oxygen/ fraction of inspired oxygen (pao2/fio2) ≤ 150 mmhg (i.e., arterial oxygen in millimeter of mercury (mmhg) divided by fraction inspired oxygen concentration [example, 0.21 for room air]). 2. clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk. 3. the subject has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product, or known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. 4. a medical condition in which the infusion of additional fluid is contraindicated (example, decompensated congestive heart failure or renal failure with fluid overload). this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. 5. shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered not able to be reversed by the principal investigator. 6. known alpha-1 antitrypsin deficiency for which the subject is already receiving alpha1-proteinase inhibitor augmentation therapy. 7. women who are pregnant or breastfeeding. female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline visit. 8. subjects for whom there is limitation of therapeutic effort such as "do not resuscitate" status. 9. currently participating in another interventional clinical trial with investigational medical product or device. 10. subjects previously requiring long-term oxygen therapy (home oxygen therapy). 11. history (within the last 2 years) of myocardial infarction, unstable angina, stroke or transient ischemic attacks, pulmonary embolism or deep venous thrombosis 12. subject has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year 13. systolic blood pressure < 100 mm hg or > 160 mm hg (uncontrolled hypertension) at the time of screening 14. alanine aminotransferase (alt) ≥ 2 times the upper limit of normal (uln) 15. any elevation of total bilirubin at the time of screening 16. estimated glomerular filtration rate (egfr) < 45 ml/min (or subject is dependent on dialysis/renal replacement therapy) at the time of screening 17. hemoglobin < 10 g/dl at the time of screening 18. absolute neutrophil count < 1000/mm3 at the time of screening 19. platelet count < 75,000/mm3 at the time of screening 20. subject has history of drug or alcohol abuse within the past 24 months 21. subject is unwilling to commit to follow-up visits 22. known history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome

1. subjects requiring invasive mechanical ventilation or icu admission or with partial pressure of arterial oxygen/ fraction of inspired oxygen (pao2/fio2) ≤ 150 mmhg (i.e., arterial oxygen in millimeter of mercury (mmhg) divided by fraction inspired oxygen concentration [example, 0.21 for room air]). 2. clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk. 3. the subject has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product, or known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. 4. a medical condition in which the infusion of additional fluid is contraindicated (example, decompensated congestive heart failure or renal failure with fluid overload). this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. 5. shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered not able to be reversed by the principal investigator. 6. known alpha-1 antitrypsin deficiency for which the subject is already receiving alpha1-proteinase inhibitor augmentation therapy. 7. women who are pregnant or breastfeeding. female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline visit. 8. subjects for whom there is limitation of therapeutic effort such as "do not resuscitate" status. 9. currently participating in another interventional clinical trial with investigational medical product or device. 10. subjects previously requiring long-term oxygen therapy (home oxygen therapy). 11. history (within the last 2 years) of myocardial infarction, unstable angina, stroke or transient ischemic attacks, pulmonary embolism or deep venous thrombosis 12. subject has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year 13. systolic blood pressure < 100 mm hg or > 160 mm hg (uncontrolled hypertension) at the time of screening 14. alanine aminotransferase (alt) ≥ 2 times the upper limit of normal (uln) 15. any elevation of total bilirubin at the time of screening 16. estimated glomerular filtration rate (egfr) < 45 ml/min (or subject is dependent on dialysis/renal replacement therapy) at the time of screening 17. hemoglobin < 10 g/dl at the time of screening 18. absolute neutrophil count < 1000/mm3 at the time of screening 19. platelet count < 75,000/mm3 at the time of screening 20. subject has history of drug or alcohol abuse within the past 24 months 21. subject is unwilling to commit to follow-up visits 22. known history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome