Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19)

Inclusion Criteria:

1. Hospitalized male or female subject ≥ 18 years of age at time of Screening who is
being treated for COVID-19.

2. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by
qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase [RT]-PCR), or other
commercial or public health assay (of any type) in any specimen during the current
hospital admission prior to randomization.

3. COVID-19 illness (symptoms) of any duration with radiographic infiltrates by imaging
(Chest X-Ray, Computed tomography (CT) scan, etc.).

4. PaO2/FIO2 ratio > 300 to ≤ 450 mmHg (i.e., arterial oxygen in mmHg divided by fraction
inspired oxygen concentration [e.g., 0.21 for room air])

5. 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).

6. Subject (or a legal representative or a nearest relative or a relative by marriage, as
appropriate) provides oral informed consent prior to initiation of any study
procedures.

Exclusion criteria:

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.