1. subject requires invasive mechanical ventilation or icu admission. 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 (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or commercial immunoglobulin. 4. subject has known (documented) hereditary fructose intolerance (hfi). 5. a medical condition in which the infusion of additional fluid is contraindicated. 6. shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the principal investigator not able to be reversed. 7. subject with known (documented) thrombotic complications to polyclonal ivig therapy in the past. 8. subject with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event. 9. subject with limitations of therapeutic effort (eg, 'do not resuscitate' status). 10. female subject who are pregnant or of child-bearing potential with a positive test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline. 11. subject participating in another interventional clinical trial with investigational medical product or device.

1. subject requires invasive mechanical ventilation or icu admission. 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 (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or commercial immunoglobulin. 4. subject has known (documented) hereditary fructose intolerance (hfi). 5. a medical condition in which the infusion of additional fluid is contraindicated. 6. shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the principal investigator not able to be reversed. 7. subject with known (documented) thrombotic complications to polyclonal ivig therapy in the past. 8. subject with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event. 9. subject with limitations of therapeutic effort (eg, 'do not resuscitate' status). 10. female subject who are pregnant or of child-bearing potential with a positive test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline. 11. subject participating in another interventional clinical trial with investigational medical product or device.

subject requires invasive mechanical ventilation or icu admission. 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 (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or commercial immunoglobulin. subject has known (documented) hereditary fructose intolerance (hfi). 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 by the principal investigator not able to be reversed. subject with known (documented) thrombotic complications to polyclonal ivig therapy in the past. subject with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event. subject with limitations of therapeutic effort (eg, 'do not resuscitate' status). female subject who are pregnant or of child-bearing potential with a positive test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline. subject participating in another interventional clinical trial with investigational medical product or device.

subject requires invasive mechanical ventilation or icu admission. 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 (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or commercial immunoglobulin. subject has known (documented) hereditary fructose intolerance (hfi). 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 by the principal investigator not able to be reversed. subject with known (documented) thrombotic complications to polyclonal ivig therapy in the past. subject with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event. subject with limitations of therapeutic effort (eg, 'do not resuscitate' status). female subject who are pregnant or of child-bearing potential with a positive test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline. subject participating in another interventional clinical trial with investigational medical product or device.

1. subject requires invasive mechanical ventilation or icu admission. 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 (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or commercial immunoglobulin. 4. subject has known (documented) hereditary fructose intolerance (hfi). 5. a medical condition in which the infusion of additional fluid is contraindicated. 6. shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the principal investigator not able to be reversed. 7. subject with known (documented) thrombotic complications to polyclonal ivig therapy in the past. 8. subject with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event. 9. subject with limitations of therapeutic effort (eg, 'do not resuscitate' status). 10. female subject who are pregnant or of child-bearing potential with a positive test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline. 11. subject participating in another interventional clinical trial with investigational medical product or device.

1. subject requires invasive mechanical ventilation or icu admission. 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 (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or commercial immunoglobulin. 4. subject has known (documented) hereditary fructose intolerance (hfi). 5. a medical condition in which the infusion of additional fluid is contraindicated. 6. shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the principal investigator not able to be reversed. 7. subject with known (documented) thrombotic complications to polyclonal ivig therapy in the past. 8. subject with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event. 9. subject with limitations of therapeutic effort (eg, 'do not resuscitate' status). 10. female subject who are pregnant or of child-bearing potential with a positive test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline. 11. subject participating in another interventional clinical trial with investigational medical product or device.