Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)

Inclusion Criteria:

- Hospitalized male or female subjects of ≥ 18 years of age at time of Screening who are
being treated in the ICU for COVID-19 for not longer than 48 hours or for whom a
decision has been made that COVID-19 disease severity warrants ICU admission.

- Has laboratory-confirmed novel coronavirus {SARS-CoV-2} infection as determined by
qualitative polymerase chain reaction (PCR) (reverse transcriptase [RT]-PCR), or other
United States Food and Drug Administration (FDA)-approved diagnostic assay for
COVID-19 in any specimen during the current hospital admission prior to randomization.

- Illness (symptoms of COVID-19 of any duration requiring ICU level care), and the
following:

1. Radiographic infiltrates by imaging (chest X-Ray, computerized tomography (CT)
scan, etc.), and

2. Requiring mechanical ventilation and/or supplemental oxygen.

- Any one of the following related to COVID-19: i. Ferritin > 400 nanogram per
milliliter (ng/mL), ii. Lactate dehydrogenase (LDH) > 300 units per liter (U/L), iii.
D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 milligram per liter
(mg/L).

- Subject provides informed consent prior to initiation of any study procedures.

Exclusion Criteria:

- 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.