Outpatient Treatment With Anti-Coronavirus Immunoglobulin
Public ClinicalTrials.gov record NCT04910269. 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, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04910269
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 741 participants
Conditions and interventions
Conditions
Interventions
- Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) Biological
- Placebo Other
Biological · Other
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
- Aug 5, 2021
- Primary completion
- May 23, 2026
- Completion
- Jun 13, 2026
- Last update posted
- Aug 12, 2026
2021 – 2026
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern Arizona VA Healthcare System (074-009) | Tucson | Arizona | 85723 | — |
| VA Northern California Health Care System (074-023) | Mather | California | 95655 | — |
| Stanford University Hospital & Clinics (Site 203-003) | Palo Alto | California | 94305 | — |
| San Francisco VAMC (Site 074-002) | San Francisco | California | 94121 | — |
| Rocky Mountain Regional VA Medical Center (074-010) | Aurora | Colorado | 80045 | — |
| Henry Ford Health System Site (014-001) | Detroit | Michigan | 48202 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Cleveland Clinic Foundation (Site 207-001) | Cleveland | Ohio | 44195 | — |
| Penn State Health Milton S. Hershey Medical Center (209-002) | Hershey | Pennsylvania | 17033 | — |
| CHRISTUS Spohn Shoreline Hospital | Corpus Christi | Texas | 78404 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Intermountain Medical Center (211-001) | Murray | Utah | 84107 | — |
| UVA Health System, University Hospital (Site 210-003) | Charlottesville | Virginia | 22908 | — |
| Carilion Medical Center (Site 080-018) | Roanoke | Virginia | 24015 | — |
| Salem VA Medical Center (074-014) | Salem | Virginia | 24153 | — |
| Swedish Hospital First Hill | Seattle | Washington | 98122 | — |
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 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04910269, 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 Aug 12, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04910269 live on ClinicalTrials.gov.