Outpatient Treatment With Anti-Coronavirus Immunoglobulin

Exclusion Criteria

• •Asymptomatic and had prior symptoms from the current infection that have now resolved (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 health purposes).
• •Evidence of pneumonia and/or hypoxia due to COVID-19 (NOTE: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level).
• •Prior receipt of immunoglobulin product or passive immune therapy for SARS-CoV-2 in the past 90 days (i.e., convalescent plasma, SARS-CoV-2 monoclonal antibodies, or any IVIG).
• •Any of the following thrombotic or procoagulant conditions or disorders:
• •1. acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous 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, or protein 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 not be in the best interest of the participant or that could prevent or confound protocol assessments.