A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients

Exclusion Criteria

• •1. Participants who are admitted to hospital or for whom hospital admission is being planned at the time of Screening.
• •2. Participants requiring any form of oxygen supplementation at Screening.
• •3. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 including remdesivir.
• •4. Prior, concurrent or planned treatment with monoclonal antibodies (mAbs) against SARS-CoV-2
• •5. Have participated in a previous SARS-CoV-2 vaccine study OR outside of a study have received any SARS-CoV-2 vaccine of any kind.
• •6. Have a history of convalescent COVID-19 plasma treatment at Screening.
• •7. Fever (temperature ≥38.0° C \[≥100.4° F\]), measured orally, requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at Screening.
• •8. Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the participant at undue medical risk for study treatment.
• •9. The participant has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin A (IgA) deficiency with anti-IgA antibodies.
• •10. Decompensated congestive heart failure or renal failure with fluid overload. This includes currently uncontrolled congestive heart failure New York Heart Association Class III or IV stage heart failure.
• •11. Participants for whom there is limitation of therapeutic effort such as "Do not resuscitate" status.
• •12. Currently participating in another interventional clinical trial with investigational medical product or device.
• •13. Participants with known (documented) thrombotic complications to polyclonal intravenous immune globulin (IVIG) therapy in the past.
• •14. Participant has medical condition (other than COVID-19) that is projected to limit lifespan to ≤ 1 year.
• •15. Participant has history of drug or alcohol abuse within the past 12 months.
• •16. Participant is unwilling to commit to follow-up visits.
• •17. Women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study.
• •* True abstinence: When this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception).
• •* Note: Women who are \>55 years and with the absence of menses in the last 12 months are considered to be not of childbearing potential. Female participants of childbearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (hCG)-based assay at Screening/Baseline Visit.