A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults
Condition: COVID-19
MeSH terms: COVID-19
Intervention: COVID-HIGIV; Placebo (saline)
Intervention description: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.; The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: SARS-CoV-2; Coronavirus disease 2019; Severe acute respiratory syndrome coronavirus 2; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies

Summary:

      This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin
      Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults.
      Twenty-eight healthy adult subjects will be enrolled into the study to receive a single dose
      of COVID-HIGIV or placebo with 84 days of safety and PK follow-up post-administration.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able and willing to provide written informed consent (voluntarily signed by the
             subject) prior to performing study procedures.

          2. Females and males 18-60 years of age, inclusive.

          3. Have a body mass index (BMI) less than or equal to 35.0 kg/m2.

          4. Women who are either:

             A) Not of childbearing potential: either surgically sterile (at least six weeks post
             bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or post-menopausal
             (defined as ≥50 years of age with a history of ≥12 months without menses prior to
             randomization in the absence of other pathologic or physiologic causes, following
             cessation of exogenous sex-hormonal treatment); OR

             B) Women of childbearing potential (WOCBP) who are not planning to be pregnant during
             the study period and meet all of the following criteria:

             Negative serum pregnancy test (PT) at Screening; and Negative PT prior to dosing at
             Day 1; and

             Use of a highly effective contraception during the study period:

               -  Hormonal contraceptives (e.g., implants, pills, patches) initiated ≥30 days prior
                  to Day 1; or

               -  Intrauterine device (IUD) inserted ≥30 days prior to Day 1; or

               -  Double barrier type of birth control (e.g., male condom with female diaphragm,
                  male condom with cervical cap).

          5. Subject understands and agrees to comply with planned study procedures.

          6. Healthy as determined by the Principal Investigator based on medical history, physical
             exam, vital signs, urinalysis, blood chemistry and hematology test results at
             Screening and evidence of no prior exposure to SARS-CoV-2 (i.e., Reverse transcription
             polymerase chain reaction [RT-PCR] negative for SARS-CoV-2 and negative for SARS-CoV-2
             antibodies) at Screening.

        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.