Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)

• Status: Completed
• Trial end date: 2021-05-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota
• Collaborators: International Network for Strategic Initiatives in Global HIV Trials (INSIGHT); National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH); The International Network for Strategic Initiatives in Global HIV Trials
• Treatments: Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; Remdesivir

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