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NCT04910269 · ClinicalTrials.gov registry record · Phase 3
Outpatient Treatment With Anti-Coronavirus Immunoglobulin
A Phase 3 study of COVID-19 and SARS CoV 2 Infection, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 820
- Enrollment target
- 20
- Study locations
NCT04910269: Recruiting Phase 3 study of COVID-19 and SARS CoV 2 Infection, sponsored by University of Minnesota.
NCT04910269 is a Phase 3 study of COVID-19 and SARS CoV 2 Infection that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 820 participants, below the 38,462-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
NCT04910269, a Phase 3 study of COVID-19 and SARS CoV 2 Infection, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 820 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC) (INSIGHT 012) trial is to compare the safety and efficacy of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) versus placebo among adults with recently diagnosed severe acute respiratory syndrome - coronavirus 2 (SARS-CoV2) infection who do not require hospitalization. The primary endpoint of this double-blind randomized trial is a five-category ordinal outcome that assesses the participant's clinical status seven days after the infusion of hIVIG or placebo. 1. Asymptomatic and no limitations in usual activity due to COVID-19 2. Mild COVID-19 illness or minor limitations to usual activity 3. Moderate COVID-19 illness and with major limitations to usual activity 4. Severe COVID-19 or serious disease manifestation from COVID-19 5. Critical illness from COVID-19 or Death Two strata of participants will be identified for analysis purposes. Stratum 2 will be participants who receive direct-acting antivirals (DAAs) or other anti-SARS-CoV2 agents that are approved/available and recommended for use as part of standard of care (SOC), estimated to be about 20% of participants. Stratum 1 will be participants who do not receive this agents, estimated to be about 80% of participants.
Primary Outcome
The primary outcome is to compare the safety and efficacy of a single infusion of hIVIG versus placebo on clinical status after seven days. Outcome will be reported as the percent of participants who fall into each of 5 clinical status categories as defined below. 1. Asymptomatic and no limitations in usual activity due to COVID-19 2. Mild COVID-19 illness or minor limitations to usual activity 3. Moderate COVID-19 illness and with major limitations to usual activity 4. Severe COVID-19 or serio
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)
Study Locations (20)
California
- VA Northern California Health Care System (074-023) - Mather
- Stanford University Hospital & Clinics (Site 203-003) - Palo Alto
- San Francisco VAMC (Site 074-002) - San Francisco
Texas
- Hendrick Medical Center - Abilene
- CHRISTUS Spohn Shoreline Hospital - Corpus Christi
- UT Southwestern Medical Center - Dallas
District of Columbia
- MedStar Health Research Institute - Washington D.C.
- Washington DC Veterans Affairs Medical Center - Washington D.C.
Michigan
- Henry Ford Health System Site (014-001) - Detroit
- Infusion Associates - Grand Rapids
New York
- Mount Sinai Beth Israel Hospital - New York
- Icahn School of Medicine at Mount Sinai - New York
Virginia
- UVA Health System, University Hospital (Site 210-003) - Charlottesville
- Carilion Medical Center (Site 080-018) - Roanoke
Arizona
- Southern Arizona VA Healthcare System (074-009) - Tucson
Colorado
- Rocky Mountain Regional VA Medical Center (074-010) - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 820 participants |
| Start Date | 2021-08-06 |
| Est. Completion | 2026-08-01 |
| Phase | Phase 3 |
What NCT04910269 shows while recruiting
NCT04910269 is an interventional study that assigns participants to a tested intervention. The registered 820 participants enrollment target is mid-sized for trials with a published cap, below the 38,462-participant average among 298 other COVID-19 trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04910269 names 20 study sites across 12 states, led by California, Texas, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04910269 about?
NCT04910269 is a clinical study titled "Outpatient Treatment With Anti-Coronavirus Immunoglobulin". The primary objective of the Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC) (INSIGHT 012) trial is to compare the safety and efficacy of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) versus placebo among adults with recently diagnosed severe acut...
What is the current status of trial NCT04910269?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 820 participants. The study started on 2021-08-06. Estimated completion is 2026-08-01.
What conditions does trial NCT04910269 study?
This clinical trial studies the following conditions: COVID-19, SARS CoV 2 Infection, COVID.
What interventions are being tested in trial NCT04910269?
The interventions under investigation include: Placebo (OTHER), Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04910269?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04910269 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04910269's enrollment target sits among peer trials
820 87th of 298 higher than 211 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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