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Outpatient Treatment With Anti-Coronavirus Immunoglobulin
NCT04910269 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04910269
The ClinicalTrials.gov registry entry for NCT04910269 describes a study currently listed as recruiting. 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 820 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 3 conditions, with Covid19 appearing as the primary indexed condition, and to 2 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: NCT04910269 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Texas, District of Columbia. 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 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: Covid19, COVID, SARS-CoV2 Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04910269?
The interventions under investigation include: Placebo (OTHER), 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 NCT04910269?
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 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.
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