A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes to SARS-CoV-2 Uninfected Adults

Exclusion Criteria

• •1. Use of any investigational product within 30 days or SARS-CoV-2 monoclonal antibodies and COVID-19 convalescent plasma within 90 days prior to Screening or anticipated receipt during the study follow-up period, or participant plans to participate in another clinic study during the study period.
• •2. Receipt of 1 or 2 doses COVID-19 vaccine within 60 days prior to screening or during the study follow-up period.
• •3. SARS-CoV-2 IgG antibody levels \>80 AU/mL as determined by the Diasorin LIAISON SARS-CoV-2 S1/S2 IgG antibody assay.
• •4. Screening clinical laboratory test result greater than the laboratory's upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), random glucose, total and/or direct bilirubin, blood urea nitrogen (BUN), or creatinine. Other serum chemistry parameters that are not within the reference range will not be considered exclusionary unless deemed clinically significant by the principal investigator.
• •5. Positive laboratory evidence of current infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV). Note: Positive anti-HCV antibody result along with a negative HCV PCR would NOT be exclusionary.
• •6. History of allergy or hypersensitivity to blood or plasma products or to COVID-HIG excipients (proline, PS80).
• •7. History of allergy to latex or rubber.
• •8. History of hemolytic anemia.
• •9. History of Immunoglobulin A (IgA) deficiency.
• •10. Receipt of any blood product within the past 12 months.
• •11. Plasma donation within 7 days or blood loss/donation (\>450 mL) within 56 days of dosing.
• •12. History of known congenital or acquired immunodeficiency or receipt of immunosuppressive therapy (e.g., prednisone or equivalent for more than two consecutive weeks within the past three months).
• •13. History of thrombosis or hypercoagulable state with increased risk of thrombosis.
• •14. Receipt of a live vaccine within 30 days prior to screening or anticipated receipt of a live vaccine during the study period.
• •15. Currently pregnant, breastfeeding, or planning to become pregnant during the study.
• •16. History of, or suspected substance abuse problem (including alcohol).
• •17. Any planned elective surgery or procedure during the follow-up period that impacts study compliance.
• •18. Other condition which may place participant at increased risk due to participation in the study or may impact study compliance as determined by the investigator.
• •19. An opinion of the investigator (or designee) that it would not be in the best interest of the individual to participate in the study.