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NCT04546581 · ClinicalTrials.gov registry record · Phase 3
Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)
A Phase 3 study of COVID-19 and SARS-CoV-2, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 3
- Development phase
- 593
- Enrollment target
- 20
- Study locations
NCT04546581: Completed Phase 3 study of COVID-19 and SARS-CoV-2, sponsored by University of Minnesota.
NCT04546581 is a Phase 3 study of COVID-19 and SARS-CoV-2 that has completed, run by University of Minnesota. The registered enrollment target is 593 participants, below the 38,463-participant average among 298 other COVID-19 trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04546581, a Phase 3 study of COVID-19 and SARS-CoV-2, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 593 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The primary objective is to compare the clinical status of patients in each group on day 7 of follow-up using the primary ordinal outcome with 7 mutually exclusive categories: 7\. Death 6. End-organ failure 5. Life-threatening end-organ dysfunction 4. Serious end-organ dysfunction 3. Moderate end-organ dysfunction 2. Limiting symptoms due to COVID-19 1\. No limiting symptoms due to COVID-19 Outcome is reported as the percent of participants in each of 7 categories. Primary ordinal outcome bas
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 |
What the finished NCT04546581 record still lists
NCT04546581 is an interventional study that assigns participants to a tested intervention. The registered 593 participants enrollment target is mid-sized for trials with a published cap, below the 38,463-participant average among 298 other COVID-19 trials with a reported enrollment target (98% lower).
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.
NCT04546581 names 20 study sites across 12 states, led by Colorado, Texas, Missouri.
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).
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).
Who is sponsoring clinical trial NCT04546581?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04546581's enrollment target sits among peer trials
593 101st of 298 higher than 198 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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