Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19

Inclusion Criteria:

1. Hospitalized male or female subject ≥ 18 years of age at the time of Screening who is
being treated for COVID-19. Subjects must be screened within 48 hours (≤ 48 hours) of
hospital admission.

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 in any specimen during the current hospital
admission prior to randomization.

3. COVID-19 illness (symptoms) of any duration, including both of the following:

1. Radiographic infiltrates by imaging (chest X-Ray, computerized tomography (CT)
scan, etc.) and/or clinical assessment (evidence of rales/crackles on the exam)
with peripheral oxygen saturation by pulse oximetry (SpO2) <94% on room air

2. 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)

4. Subjects provides informed consent prior to the initiation of any study procedures.

Exclusion Criteria:

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).