Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)
Public ClinicalTrials.gov record NCT04546581. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04546581
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 593 participants
Conditions and interventions
Interventions
- Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) Biological
- Placebo Other
- Remdesivir Drug
Biological · Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 8, 2020 (Actual)
- Primary completion
- May 21, 2021 (Actual)
- Completion
- May 21, 2021 (Actual)
- Last update posted
- Apr 4, 2022
2020 – 2021
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Penrose Hospital | Colorado Springs | Colorado | 80907 | — |
| St. Francis Health Services | Colorado Springs | Colorado | 80907 | — |
| St. Anthony Hospital | Lakewood | Colorado | 80228 | — |
| Saint Anthony North Health Campus | Westminster | Colorado | 80023 | — |
| Washington VA Medical Center | Washington D.C. | District of Columbia | 20422 | — |
| Redmond Regional Medical Center | Rome | Georgia | 30165 | — |
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
| University of Massachusetts | Worcester | Massachusetts | 01665 | — |
| Hennepin Healthcare Research Institute/HCMC | Minneapolis | Minnesota | 55415 | — |
| University of Missouri | Columbia | Missouri | 65212 | — |
| Cox Medical Centers | Springfield | Missouri | 65807 | — |
| FirstHealth Moore Regional Hospital | Pinehurst | North Carolina | 28394 | — |
| Ohio Health Research Institute | Columbus | Ohio | 43215 | — |
| Hendrick Medical Center | Abilene | Texas | 79601 | — |
| CHRISTUS Spohn Shoreline Hospital | Corpus Christi | Texas | 78404 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75235 | — |
| CJW Chippenham Medical Center | Richmond | Virginia | 23225 | — |
| Henrico Doctors' Hospital (HCA) | Richmond | Virginia | 23229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04546581, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 4, 2022 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04546581 live on ClinicalTrials.gov.