Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)
Condition: COVID; COVID-19; SARS-CoV-2; SARS (Severe Acute Respiratory Syndrome)
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Intervention: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG); Placebo; Remdesivir
Intervention description: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.; Participants will receive a single infusion of the placebo (saline).; Remdesivir will be given to participants in both groups as standard of care (SOC).
Intervention MeSH terms: Remdesivir; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 593.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This protocol will serve as a platform for assessing treatments for adult patients
      hospitalized for medical management of COVID-19 without related serious end-organ failure.
      Trials will involve sites around the world strategically chosen to ensure rapid enrollment.
      This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo,
      when added to standard of care (SOC), for preventing further disease progression and
      mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for
      an individual patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  SARS-CoV-2 infection documented by polymerase chain reaction (PCR) or other nucleic
             acid test (NAT) within 3 days prior to randomization OR documented by NAT more than 3
             days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2
             infection

          -  Symptomatic COVID-19 disease

          -  Duration of symptoms attributable to COVID-19 ≤ 12 days

          -  Requiring inpatient hospital medical care for clinical manifestations of COVID-19
             (admission for public health or quarantine only is not included)

          -  Willingness to abstain from participation in other COVID-19 treatment trials until
             after study Day 7

          -  Provision of informed consent by participant or legally authorized representative

        Exclusion Criteria:

          -  Prior receipt of SARS-CoV-2 hIVIG or convalescent plasma from a person who recovered
             from COVID-19 at any time

          -  Prior receipt of standard IVIG (not hyperimmune to SARS-CoV-2) within 45 days

          -  Current or predicted imminent (within 24 hours) requirement for any of the following:

               1. Invasive ventilation

               2. Non-invasive ventilation

               3. Extracorporeal membrane oxygenation

               4. Mechanical circulatory support

               5. Continuous vasopressor therapy

          -  History of allergy to IVIG or plasma products

          -  History of selective IgA deficiency with documented presence of anti-IgA antibodies

          -  Any medical conditions for which receipt of the required volume of intravenous fluid
             may be dangerous to the patient (includes New York Association Class III or IV stage
             heart failure)

          -  Any of the following thrombotic or procoagulant disorders:

               1. Acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous
                  thrombosis within 28 days of randomization

               2. History of prothrombin gene mutation 20210, homozygous Factor V Leiden mutations,
                  antithrombin III deficiency, protein C deficiency, protein S deficiency or
                  antiphospholipid syndrome

          -  Any condition for which, in the opinion of the investigator, participation would not
             be in the best interest of the subject or that could prevent, limit, or confound the
             protocol-specified assessments