A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults

Exclusion Criteria

• •1. Use of any investigational product, within 30 days prior to Screening, or use of investigational SARS-CoV-2 vaccines, SARS-CoV-2 monoclonal antibodies or COVID-19 convalescent plasma at any time prior to Screening or during the study follow-up period, or subject plans to participate in another clinical study during the study period.
• •2. 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 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.
• •3. History of allergy or hypersensitivity to blood or plasma products or to COVID-HIGIV excipients (proline, PS80).
• •4. History of allergy to latex or rubber.
• •5. History of hemolytic anemia.
• •6. History of Immunoglobulin A (IgA) deficiency.
• •7. Receipt of any blood product within the past 12 months.
• •8. Plasma donation within 7 days or significant blood loss or blood donation within 56 days of randomization/dosing.
• •9. 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).
• •10. History of thrombosis or hypercoagulable state with increased risk of thrombosis.
• •11. History of clinically significant chronic illness (e.g., requiring hospitalization in the past three months) such as cardiac, pulmonary, renal, hepatic or other chronic conditions.
• •12. Receipt of a live vaccine within 28 days prior to screening or anticipated receipt of a live vaccine during the study period.
• •13. Currently pregnant, breastfeeding, or planning to become pregnant during the study.
• •14. History of, or suspected substance abuse problem (including alcohol).
• •15. Other medical condition which may place subject at increased risk due to participation in the study as determined by the investigator.
• •16. Any planned elective surgery during the study period.
• •17. An opinion of the investigator that it would be unwise to allow the individual to be randomized into the study.