- clinical evidence of any significant acute or chronic disease or pathophysiologic manifestations (eg, complications of covid-19 standard medical treatments) 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 a past history of any hypersensitivity reactions to commercial immunoglobulin. - 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. - subjects with known (documented) thrombotic complications to polyclonal ivig therapy in the past. - subjects with current or prior myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event (within the past 12 months) or who have a history of thromboembolic events of unknown etiology. - subjects with limitations of therapeutic effort. - female subjects 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. - subjects participating in another interventional clinical trial with investigational medical product or device. - known history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome. - presence of malignancy (either new diagnosis of malignancy or known residual disease) within the past 12 months. - creatinine at screening is ≥ 4 mg/dl (or subject is dependent on dialysis/renal replacement therapy). - known immunoglobulin a (iga) deficiency with anti-iga serum antibodies. - uncontrolled hypertension at the time of screening (systolic blood pressure > 200 mm hg) or refractory severe hypotension with sustained systolic blood pressure < 90 mm hg unresponsive to vasopressors.

- clinical evidence of any significant acute or chronic disease or pathophysiologic manifestations (eg, complications of covid-19 standard medical treatments) 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 a past history of any hypersensitivity reactions to commercial immunoglobulin. - 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. - subjects with known (documented) thrombotic complications to polyclonal ivig therapy in the past. - subjects with current or prior myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event (within the past 12 months) or who have a history of thromboembolic events of unknown etiology. - subjects with limitations of therapeutic effort. - female subjects 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. - subjects participating in another interventional clinical trial with investigational medical product or device. - known history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome. - presence of malignancy (either new diagnosis of malignancy or known residual disease) within the past 12 months. - creatinine at screening is ≥ 4 mg/dl (or subject is dependent on dialysis/renal replacement therapy). - known immunoglobulin a (iga) deficiency with anti-iga serum antibodies. - uncontrolled hypertension at the time of screening (systolic blood pressure > 200 mm hg) or refractory severe hypotension with sustained systolic blood pressure < 90 mm hg unresponsive to vasopressors.