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

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID, COVID-19, SARS-CoV-2, SARS (Severe Acute Respiratory Syndrome)

In brief

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.

Key facts

Study ID

NCT04546581

Run by

University of Minnesota

People needed

593

Starts

2020-10-08

Expected to finish

2021-05-21

Last updated by the study team

2022-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• Invasive ventilation
• Non-invasive ventilation
• Extracorporeal membrane oxygenation
• Mechanical circulatory support
• 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:
• Acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization
• 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

Where it is running

• Penrose Hospital — Colorado Springs, Colorado, United States
• St. Francis Health Services — Colorado Springs, Colorado, United States
• St. Anthony Hospital — Lakewood, Colorado, United States
• Saint Anthony North Health Campus — Westminster, Colorado, United States
• Washington VA Medical Center — Washington D.C., District of Columbia, United States
• Redmond Regional Medical Center — Rome, Georgia, United States
• National Institutes of Health Clinical Center — Bethesda, Maryland, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• Hennepin Healthcare Research Institute/HCMC — Minneapolis, Minnesota, United States
• University of Missouri — Columbia, Missouri, United States
• Cox Medical Centers — Springfield, Missouri, United States
• FirstHealth Moore Regional Hospital — Pinehurst, North Carolina, United States
• Ohio Health Research Institute — Columbus, Ohio, United States
• Hendrick Medical Center — Abilene, Texas, United States
• CHRISTUS Spohn Shoreline Hospital — Corpus Christi, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• CJW Chippenham Medical Center — Richmond, Virginia, United States
• Henrico Doctors' Hospital (HCA) — Richmond, Virginia, United States
• Aarhus Universitetshospital, Skejby — Aarhus, Denmark
• Bispebjerg Hospital — Copenhagen, Denmark
• CHIP, Department of Infectious Diseases, Section 2100 — Copenhagen, Denmark
• Herlev-Gentofte Hospital — Hellerup, Denmark
• Nordsjællands Hospital, Hillerød — Hillerød, Denmark
• Hvidovre University Hospital, Department of Infectious Diseases — Hvidovre, Denmark
• Kolding Sygehus — Kolding, Denmark

Full record on ClinicalTrials.gov

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