Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: GAMUNEX-C; Standard Medical Treatment
Intervention description: Intravenous Immune Globulin (Human), 10% Caprylate/Chromatography Purified.; SMT per local policies or guidelines.
Intervention MeSH terms: Immunoglobulins, Intravenous
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronavirus Disease; Severe acute respiratory syndrome coronavirus 2; SARS-CoV-2; Coronavirus Infections; Coronaviridae Infections; Virus Diseases; Immunoglobulins; Antibodies; Gamma-globulins; Immunoglobulins, Intravenous; Immunologic Factors; Physiological Effects of Drugs

Summary:

      The purpose of the study is to determine if a high dose of Intravenous Immune Globulin (IVIG)
      plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in
      hospitalized participants with COVID-19 requiring admission to the ICU through Day 29.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized male or female subjects of ≥ 18 years of age at time of Screening who are
             being treated in the ICU for COVID-19 for not longer than 48 hours or for whom a
             decision has been made that COVID-19 disease severity warrants ICU admission.

          -  Has laboratory-confirmed novel coronavirus {SARS-CoV-2} infection as determined by
             qualitative polymerase chain reaction (PCR) (reverse transcriptase [RT]-PCR), or other
             United States Food and Drug Administration (FDA)-approved diagnostic assay for
             COVID-19 in any specimen during the current hospital admission prior to randomization.

          -  Illness (symptoms of COVID-19 of any duration requiring ICU level care), and the
             following:

               1. Radiographic infiltrates by imaging (chest X-Ray, computerized tomography (CT)
                  scan, etc.), and

               2. Requiring mechanical ventilation and/or supplemental oxygen.

          -  Any one of the following related to COVID-19: i. Ferritin > 400 nanogram per
             milliliter (ng/mL), ii. Lactate dehydrogenase (LDH) > 300 units per liter (U/L), iii.
             D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 milligram per liter
             (mg/L).

          -  Subject provides informed consent prior to initiation of any study procedures.

        Exclusion Criteria:

          -  Clinical evidence of any significant acute or chronic disease or pathophysiologic
             manifestations (eg, complications of COVID-19 standard medical treatments) that, in
             the opinion of the investigator, may place the subject at undue medical risk.

          -  The subject has had a known (documented) serious anaphylactic reaction to blood, any
             blood-derived or plasma product or a past history of any hypersensitivity reactions to
             commercial immunoglobulin.

          -  A medical condition in which the infusion of additional fluid is contraindicated.

          -  Shock that is unresponsive to fluid challenge and/or multiple vasopressors and
             accompanied by multiorgan failure considered by the Principal Investigator not able to
             be reversed.

          -  Subjects with known (documented) thrombotic complications to polyclonal IVIG therapy
             in the past.

          -  Subjects with current or prior myocardial infarction, stroke, deep vein thrombosis, or
             thromboembolic event (within the past 12 months) or who have a history of
             thromboembolic events of unknown etiology.

          -  Subjects with limitations of therapeutic effort.

          -  Female subjects who are pregnant or of child-bearing potential with a positive test
             for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at
             Screening/Baseline.

          -  Subjects participating in another interventional clinical trial with investigational
             medical product or device.

          -  Known history of prothrombin gene mutation 20210, homozygous Factor V Leiden
             mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or
             antiphospholipid syndrome.

          -  Presence of malignancy (either new diagnosis of malignancy or known residual disease)
             within the past 12 months.

          -  Creatinine at Screening is ≥ 4 mg/dL (or subject is dependent on dialysis/renal
             replacement therapy).

          -  Known Immunoglobulin A (IgA) deficiency with anti-IgA serum antibodies.

          -  Uncontrolled hypertension at the time of Screening (systolic blood pressure > 200 mm
             Hg) or refractory severe hypotension with sustained systolic blood pressure < 90 mm Hg
             unresponsive to vasopressors.