Outpatient Treatment With Anti-Coronavirus Immunoglobulin

Inclusion Criteria:

• Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with animmunosuppressed condition.

• Positive test for SARS-CoV-2 within ≤5 days (if >1 test, the first positive iswithin ≤5 days). Tests may include an institutional-based nucleic acid amplificationtest (NAAT), or any protocol-approved rapid test.

• Within ≤5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection.

• Agrees to not participate in another clinical trial for the treatment or managementof SARS-CoV-2 infection through Day 7, or until hospitalized or significant diseaseprogression if prior to Day 7 (defined by ordinal category 4 or 5).

• Participant provides written informed consent prior to study procedures, andunderstands and agrees to adhere to planned study procedures through Day 28.

Ongoing immunosuppressive condition or immunosuppressive treatment, includes:

1. Steroids equivalent to prednisone > 10 mg/day for at least the last 28 days

2. Rheumatologic or autoimmune disorder treated with a biologic or non-biologicimmunosuppressive therapy

3. Antirejection medicine after solid organ or stem cell transplantation

4. Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy inthe last 12 months

5. Primary or acquired severe B- or T-lymphocyte immune dysfunction

6. HIV infection

7. Splenectomy or functional asplenia

Exclusion Criteria:

• Asymptomatic and had prior symptoms from the current infection that have nowresolved (for >24 hours).

• Asymptomatic and has received a vaccination for COVID-19 (≥1 dose).

• Undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public healthpurposes).

• Evidence of pneumonia and/or hypoxia due to COVID-19 (NOTE: chest imaging is notrequired, but if available it should not show new infiltrates suggestive ofpneumonia; hypoxia is defined by new oxygen supplementation or increase abovepre-illness level).

• Prior receipt of immunoglobulin product or passive immune therapy for SARS-CoV-2 inthe past 90 days (i.e., convalescent plasma, SARS-CoV-2 monoclonal antibodies, orany IVIG).

• Any of the following thrombotic or procoagulant conditions or disorders:

1. acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deepvenous thrombosis within 28 days of randomization.

2. prothrombin gene mutation 20210, homozygous Factor V Leiden mutations,antiphospholipid syndrome, or a deficiency in antithrombin III, protein C, orprotein S.

• History of hypersensitivity to blood, plasma or IVIG excipients.

• Known immunoglobulin A (IgA) deficiency or anti-IgA antibodies.

• In the opinion of the investigator, any condition for which participation would notbe in the best interest of the participant or that could prevent or confoundprotocol assessments.