A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients
Condition: COVID-19; Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
MeSH terms: Infections; COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome; Syndrome
Intervention: C19-IG 20%; 0.9% Sodium chloride
Intervention description: Anti-COVID-19 Immune Globulin (Human) 20%; C19-IG 20% matching placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 465.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronavirus disease; Severe acute respiratory syndrome coronavirus 2; SARS-CoV-2; COVID-19; Asymptomatic

Summary:

      The purpose of the study is to compare the efficacy of anti-COVID-19 immune globulin (human)
      20% (C19-IG 20%) (2 doses) versus placebo with regard to the percentage of asymptomatic
      participants who remain asymptomatic, i.e., who do not develop symptomatic coronavirus
      disease 2019 (COVID-19) through Day 14 as per the protocol defined criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ambulatory male or female outpatients ≥ 18 years of age who have laboratory-confirmed
             severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined
             by qualitative PCR (reverse transcriptase (RT)-PCR), or other commercial or public
             health assay approved by regulatory authorities as a diagnostic test for COVID-19
             (inclusive of SARS-CoV-2 antigen testing or other approved rapid testing platforms) in
             any specimen ≤ 5 days prior to randomized treatment.

          2. Asymptomatic with no constitutional COVID-19 illness (evident symptoms), specifically
             no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache
             that is unrelated to pre-existing conditions (example, migraine), sore throat that is
             unrelated to other pre-existing medical conditions (example, allergies,
             gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with
             previous medical condition, or evidence of pneumonia at Screening.

          3. Pulse oximetry peripheral oxygen saturation (SpO2) (oxygen saturation) on room air >
             94% (i.e., 95% to 100%) at Screening.

          4. National Early Warning Score (NEWS) ≤ 2 points at Screening.

          5. Participant provides informed consent (ICF) prior to initiation of any study
             procedures.

        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.