Outpatient Treatment With Anti-Coronavirus Immunoglobulin

NCT04910269 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: INSIGHT122021-001663-24
• Study Type: interventional
• Target: 820
• Locations: 14 countries
• Sites: 66

Brief 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. 1.Asymptomatic and no limitations in usual activity due to COVID-19
2. 2.Mild COVID-19 illness or minor limitations to usual activity
3. 3.Moderate COVID-19 illness and with major limitations to usual activity
4. 4.Severe COVID-19 or serious disease manifestation from COVID-19
5. 5.Critical illness from COVID-19 or Death

Conditions

COVID; SARS-CoV2 Infection; Covid19

Keywords

immunotherapy; hIVIG; early treatment

Outcome Measures

Primary Outcomes (1)

• Clinical Status

  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 serious disease manifestation from COVID-19 5. Critical illness from COVID-19 or Death

  7 days

Secondary Outcomes (15)

• All-cause hospitalization or death through 28 days.

  28 days

• All-cause mortality through 28 days.

  28 days

• Significant Disease Progression

  28 days

• Ordinal Scale Distribution

  4, 14, 28 days

• Disease Progression Through 7 Days

  7 days

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Biological: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) 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.

Treatment Group

Placebo OTHER

Infusion of 35 milliliters standard isotonic saline

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization.
• 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.

Sponsors & Collaborators

• International Network for Strategic Initiatives in Global HIV Trials (INSIGHT): collaborator
• University of Minnesota: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (66)

Southern Arizona VA Healthcare System (074-009)

Tucson, Arizona, 85723, United States

TERMINATED

VA Northern California Health Care System (074-023)

Mather, California, 95655, United States

TERMINATED

Stanford University Hospital & Clinics (Site 203-003)

Palo Alto, California, 94305, United States

RECRUITING

San Francisco VAMC (Site 074-002)

San Francisco, California, 94121, United States

TERMINATED

Rocky Mountain Regional VA Medical Center (074-010)

Aurora, Colorado, 80045, United States

TERMINATED

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

WITHDRAWN

Washington DC Veterans Affairs Medical Center

Washington D.C., District of Columbia, 20422, United States

WITHDRAWN

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

WITHDRAWN

Henry Ford Health System Site (014-001)

Detroit, Michigan, 48202, United States

RECRUITING

Infusion Associates

Grand Rapids, Michigan, 49525, United States

WITHDRAWN

Mount Sinai Beth Israel Hospital

New York, New York, 10003, United States

WITHDRAWN

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

TERMINATED

Cleveland Clinic Foundation (Site 207-001)

Cleveland, Ohio, 44195, United States

RECRUITING

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

Hershey, Pennsylvania, 17033, United States

RECRUITING

Hendrick Medical Center

Abilene, Texas, 79601, United States

WITHDRAWN

CHRISTUS Spohn Shoreline Hospital

Corpus Christi, Texas, 78404, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Intermountain Medical Center (211-001)

Murray, Utah, 84107, United States

RECRUITING

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

Charlottesville, Virginia, 22908, United States

RECRUITING

Carilion Medical Center (Site 080-018)

Roanoke, Virginia, 24015, United States

RECRUITING

Salem VA Medical Center (074-014)

Salem, Virginia, 24153, United States

TERMINATED

Swedish Hospital First Hill

Seattle, Washington, 98122, United States

RECRUITING

Instituto Medico Platense

La Plata, Buenos Aires, B1900AVG, Argentina

RECRUITING

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

Mar del Plata, Buenos Aires, B7600FYK, Argentina

RECRUITING

Clínica Central S.A. (611-028)

Villa Regina, Río Negro Province, R8336, Argentina

RECRUITING

Hospital General de Agudos JM Ramos Mejia

Buenos Aires, C1221ADC, Argentina

RECRUITING

St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

RECRUITING

Odense University Hospital

Odense, C, 5000, Denmark

RECRUITING

Aarhus Universitetshospital, Skejby

Aarhus, N, 8200, Denmark

RECRUITING

Department of Infectious Diseases

Aalborg, 9000, Denmark

RECRUITING

Rigshospitalet, CHIP

Copenhagen, 2100, Denmark

RECRUITING

Bispebjerg Hospital

Copenhagen, 2400, Denmark

RECRUITING

Herlev/Gentofte Hospital

Hellerup, 2900, Denmark

RECRUITING

Hvidovre University Hospital, Department of Infectious Diseases

Hvidovre, 2650, Denmark

RECRUITING

Kolding Sygehus

Kolding, 6000, Denmark

RECRUITING

Dept of Critical Care and Pulmonary Medicine, Evangelismos General Hospital

Athens, Attica, 10676, Greece

RECRUITING

3rd Dept of Medicine, Medical School

Athens, Attica, 11527, Greece

RECRUITING

Laiko Athens General Hospital

Athens, Attica, 11527, Greece

RECRUITING

Department of Clinical Therapeutics of Alexandra Hospital

Athens, Attica, 11528, Greece

RECRUITING

4th Department of Internal Medicine

Athens, Attica, 12462, Greece

RECRUITING

All India Institute of Medical Sciences (AIIMS)

Jodhpur, Rajasthan, 342005, India

WITHDRAWN

Postgraduate Institute of Medical Education and Research (PGIMER)

Chandigarh, 160012, India

WITHDRAWN

University Malaya Medical Centre (Site 612-501)

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

RECRUITING

Hospital General Dr. Manuel Gea Gonzáles

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Instituto Nacional de Enfermedades Respiratorias Ismael Cosió Villegas

Mexico City, Mexico City, 14080, Mexico

RECRUITING

CHRISTUS Centro de Excelencia en Investigacion (Obispado)

Monterrey, Nuevo León, 64060, Mexico

WITHDRAWN

Hospital General Dr. Aurelio Valdivieso

Oaxaca City, OA, 68050, Mexico

RECRUITING

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

Lima, 15012, Peru

RECRUITING

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

CAP Can Bou

Castelldefels, Barcelona, 08860, Spain

RECRUITING

CAP El Maresme

Mataró, Barcelona, 08303, Spain

RECRUITING

CAP Corbera

Barcelona, 08757, Spain

RECRUITING

Siriraj Hospital (Site 613-002)

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Chulalongkorn University and The HIV-NAT

Pathum Wan, Bangkok, 10330, Thailand

RECRUITING

Khon Kaen University, Srinagarind Hospital (Site 613-003)

Khon Kaen, 40002, Thailand

RECRUITING

Bamrasnaradura Infections Diseases Institute (613-007)

Nonthaburi, 11000, Thailand

RECRUITING

MRC/UVRI & LSHTM Uganda Research Unit

Entebbe, Uganda

RECRUITING

Joint Clinical Research Center (JCRC)

Kampala, Uganda

RECRUITING

Makerere University Lung Institute (Site 634-604)

Kampala, Uganda

RECRUITING

St. Francis Hospital, Nsambya

Kampala, Uganda

RECRUITING

Lira Regional Referral Hospital

Lira, Uganda

RECRUITING

Masaka Regional Referral Hospital

Masaka, Uganda

RECRUITING

Central City Clinical Hospital of Ivano-Frankivsk City Council

Ivano-Frankivsk, 76018, Ukraine

RECRUITING

University College London Hospitals

London, WC1E 6JB, United Kingdom

RECRUITING

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 36216961 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

HIV hyperimmune globulin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cavan Reilly, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Schoenecker, MPH

CONTACT

612-624-5902; webe0376@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 2, 2021
• Study Start: August 6, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

GR (5); US (22); TH (4); UG (6); IN (2); AR (4); DK (8); ME (5); UA (1); AU (1); ES (4); GB (2); PE (1); MY (1)