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NCT04910269

Outpatient Treatment With Anti-Coronavirus Immunoglobulin

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

820 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-06

Study Completion Date

2026-08-01

Brief Summary

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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.

Detailed Description

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The primary objective will be addressed by testing two hypotheses aimed at assessing whether hIVIG + standard of care (SOC) is superior to placebo + SOC for the primary ordinal endpoint at Day 7. These hypotheses will be tested for the following two groups: a) among all randomized participants (stratum 1 and 2), and b) among only participants enrolled in stratum 1. For the primary analysis, overall type 1 error will be controlled at 5% by using a 2-sided significance level of 0.035 for each hypothesis. This significance level was obtained using the correlation between the test statistics for the proportional log odds ratio for all randomized participants and for this log odds ratio for those in stratum 1. This correlation was determined to be 0.895. With this approach hIVIG will be considered superior to placebo if either of the two hypotheses is rejected.

Participants will be randomized to a single infusion of an hIVIG product or placebo in a 1:1 allocation. Randomization will be stratified by study site pharmacy and the two SOC strata.

Conditions

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COVID SARS-CoV2 Infection Covid19

Keywords

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immunotherapy hIVIG early treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment Group

Participants in this group will receive the investigational treatment in addition to standard of care.

Group Type EXPERIMENTAL

Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)

Intervention Type BIOLOGICAL

The hIVIG product is administered as a single dose of 3.5 grams, or 35 milliliter at a concentration of 0.1 grams/milliliter.

Placebo Group

Participants in this group will receive a placebo in addition to standard of care.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Infusion of 35 milliliters standard isotonic saline

Interventions

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Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)

The hIVIG product is administered as a single dose of 3.5 grams, or 35 milliliter at a concentration of 0.1 grams/milliliter.

Intervention Type BIOLOGICAL

Placebo

Infusion of 35 milliliters standard isotonic saline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an immunosuppressed condition.
* Positive test for SARS-CoV-2 within ≤5 days (if \>1 test, the first positive is within ≤5 days). Tests may include an institutional-based nucleic acid amplification test (NAAT), or any protocol-approved rapid test.
* Within ≤5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection.
* Agrees to not participate in another clinical trial for the treatment or management of SARS-CoV-2 infection through Day 7, or until hospitalized or significant disease progression if prior to Day 7 (defined by ordinal category 4 or 5).
* Participant provides written informed consent prior to study procedures, and understands and agrees to adhere to planned study procedures through Day 28.

Ongoing immunosuppressive condition or immunosuppressive treatment, includes:

1. Steroids equivalent to prednisone \> 10 mg/day for at least the last 28 days
2. Rheumatologic or autoimmune disorder treated with a biologic or non-biologic immunosuppressive therapy
3. Antirejection medicine after solid organ or stem cell transplantation
4. Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the last 12 months
5. Primary or acquired severe B- or T-lymphocyte immune dysfunction
6. HIV infection
7. Splenectomy or functional asplenia

Exclusion Criteria

* Asymptomatic and had prior symptoms from the current infection that have now resolved (for \>24 hours).
* Asymptomatic and has received a vaccination for COVID-19 (≥1 dose).
* Undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes).
* Evidence of pneumonia and/or hypoxia due to COVID-19 (NOTE: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level).
* Prior receipt of immunoglobulin product or passive immune therapy for SARS-CoV-2 in the past 90 days (i.e., convalescent plasma, SARS-CoV-2 monoclonal antibodies, or any IVIG).
* Any of the following thrombotic or procoagulant conditions or disorders:

1. acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization.
2. prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin III, protein C, or protein S.
* History of hypersensitivity to blood, plasma or IVIG excipients.
* Known immunoglobulin A (IgA) deficiency or anti-IgA antibodies.
* In the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cavan Reilly, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

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Role: primary

References

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Jha A, Barker D, Lew J, Manoharan V, van Kessel J, Haupt R, Toth D, Frieman M, Falzarano D, Kodihalli S. Efficacy of COVID-HIGIV in animal models of SARS-CoV-2 infection. Sci Rep. 2022 Oct 10;12(1):16956. doi: 10.1038/s41598-022-21223-2.

Reference Type DERIVED

PMID: 36216961 (View on PubMed)

Other Identifiers

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2021-001663-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INSIGHT12

Identifier Type: -

Identifier Source: org_study_id

Outpatient Treatment With Anti-Coronavirus Immunoglobulin

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Treatment Group

Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)

Placebo Group

Placebo

Interventions

Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)

Placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

National Institutes of Health (NIH)

International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

University of Minnesota

Responsible Party

Principal Investigators

Cavan Reilly, PhD

Locations

Southern Arizona VA Healthcare System (074-009)

VA Northern California Health Care System (074-023)

Stanford University Hospital & Clinics (Site 203-003)

San Francisco VAMC (Site 074-002)

Rocky Mountain Regional VA Medical Center (074-010)

MedStar Health Research Institute

Washington DC Veterans Affairs Medical Center

University of Maryland Medical System

Henry Ford Health System Site (014-001)

Infusion Associates

Mount Sinai Beth Israel Hospital

Icahn School of Medicine at Mount Sinai

Cleveland Clinic Foundation (Site 207-001)

Penn State Health Milton S. Hershey Medical Center (209-002)

Hendrick Medical Center

CHRISTUS Spohn Shoreline Hospital

UT Southwestern Medical Center

Intermountain Medical Center (211-001)

UVA Health System, University Hospital (Site 210-003)

Carilion Medical Center (Site 080-018)

Salem VA Medical Center (074-014)

Swedish Hospital First Hill

Instituto Medico Platense

Centro de Investigaciones Medicas de Mar del Plata (Site 611-031)

Clínica Central S.A. (611-028)

Hospital General de Agudos JM Ramos Mejia

St. Vincent's Hospital

Odense University Hospital

Aarhus Universitetshospital, Skejby

Department of Infectious Diseases

Rigshospitalet, CHIP

Bispebjerg Hospital

Herlev/Gentofte Hospital

Hvidovre University Hospital, Department of Infectious Diseases

Kolding Sygehus

Dept of Critical Care and Pulmonary Medicine, Evangelismos General Hospital

3rd Dept of Medicine, Medical School

Laiko Athens General Hospital

Department of Clinical Therapeutics of Alexandra Hospital

4th Department of Internal Medicine

All India Institute of Medical Sciences (AIIMS)

Postgraduate Institute of Medical Education and Research (PGIMER)

Hospital General Dr. Manuel Gea Gonzáles

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Instituto Nacional de Enfermedades Respiratorias Ismael Cosió Villegas

CHRISTUS Centro de Excelencia en Investigacion (Obispado)

Hospital General Dr. Aurelio Valdivieso

Unidad de Ensayos Clinicos Socios En Salud Sucursal Perú (651-009)

Hospital Universitari Germans Trias i Pujol

CAP Can Bou

CAP El Maresme

CAP Corbera