1. subjects requiring invasive mechanical ventilation or icu admission or with pao2/fio2 ≤ 150 mm hg (ie, arterial oxygen in mm hg divided by fraction inspired oxygen concentration \[eg, 0.21 for room air\]). 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 subjects have 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. 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).

1. subjects requiring invasive mechanical ventilation or icu admission or with pao2/fio2 ≤ 150 mm hg (ie, arterial oxygen in mm hg divided by fraction inspired oxygen concentration \[eg, 0.21 for room air\]). 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 subjects have 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. 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).

subjects requiring invasive mechanical ventilation or icu admission or with pao2/fio2 ≤ 150 mm hg (ie, arterial oxygen in mm hg divided by fraction inspired oxygen concentration [eg, 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 subjects have 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. 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).

subjects requiring invasive mechanical ventilation or icu admission or with pao2/fio2 ≤ 150 mm hg (ie, arterial oxygen in mm hg divided by fraction inspired oxygen concentration [eg, 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 subjects have 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. 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).

1. subjects requiring invasive mechanical ventilation or icu admission or with pao2/fio2 ≤ 150 mm hg (ie, arterial oxygen in mm hg divided by fraction inspired oxygen concentration [eg, 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 subjects have 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. 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).

1. subjects requiring invasive mechanical ventilation or icu admission or with pao2/fio2 ≤ 150 mm hg (ie, arterial oxygen in mm hg divided by fraction inspired oxygen concentration [eg, 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 subjects have 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. 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).