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Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)
NCT04546581 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Remdesivir
- BIOLOGICAL Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)
Study Locations (20)
Colorado
- Penrose Hospital — Colorado Springs
- St. Francis Health Services — Colorado Springs
- St. Anthony Hospital — Lakewood
- Saint Anthony North Health Campus — Westminster
Texas
- Hendrick Medical Center — Abilene
- CHRISTUS Spohn Shoreline Hospital — Corpus Christi
- University of Texas Southwestern Medical Center — Dallas
Missouri
- University of Missouri — Columbia
- Cox Medical Centers — Springfield
Virginia
- CJW Chippenham Medical Center — Richmond
- Henrico Doctors' Hospital (HCA) — Richmond
Other
- Aarhus Universitetshospital, Skejby — Aarhus
- Bispebjerg Hospital — Copenhagen
District of Columbia
- Washington VA Medical Center — Washington D.C.
Georgia
- Redmond Regional Medical Center — Rome
Maryland
- National Institutes of Health Clinical Center — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 593 participants |
| Start Date | 2020-10-08 |
| Est. Completion | 2021-05-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04546581
The ClinicalTrials.gov registry entry for NCT04546581 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 593 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 919 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with COVID-19 appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04546581 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Colorado, Texas, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04546581 about?
NCT04546581 is a clinical study titled "Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)". 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 hyperimmun...
What is the current status of trial NCT04546581?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 593 participants. The study started on 2020-10-08. Estimated completion is 2021-05-21.
What conditions does trial NCT04546581 study?
This clinical trial studies the following conditions: COVID-19, SARS-CoV-2, COVID, SARS (Severe Acute Respiratory Syndrome). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04546581?
The interventions under investigation include: Placebo (OTHER), Remdesivir (DRUG), Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04546581?
This trial is sponsored by University of Minnesota, which has 919 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04546581 being conducted?
This trial has 20 study locations across Colorado, District of Columbia, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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