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Could a single infusion of COVID-Fighting antibodies keep High-Risk patients out of the hospital?

NCT ID NCT04910269

Disease control Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 5 times

Summary

This study tests whether a single infusion of hyperimmune immunoglobulin (hIVIG) — concentrated antibodies from recovered COVID-19 patients — can help adults at high risk (age 55+ or with weakened immune systems) who have early COVID-19. Participants receive either the antibody infusion or a placebo (salt water) and are followed for 28 days to see if they recover faster or avoid hospitalization. The trial was suspended, so results are not yet available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG)
What this could lead to
If it works, this could provide a new treatment option for early COVID-19 in high-risk outpatients, reducing severe illness and hospital stays.
What could go wrong
This trial is suspended, so results are unknown. The treatment may not improve outcomes over placebo, and risks like infusion reactions or lack of benefit are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

741 people

The number who actually took part.

Started

Aug 2021

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID COVID19 SARS-COV2 infection

Contacts and locations

Locations

  • 3rd Dept of Medicine, Medical School

    Athens, Attica, 11527, Greece

  • 4th Department of Internal Medicine

    Athens, Attica, 12462, Greece

  • Aarhus Universitetshospital, Skejby

    Aarhus, N, 8200, Denmark

  • Bamrasnaradura Infections Diseases Institute (613-007)

    Nonthaburi, 11000, Thailand

  • Bispebjerg Hospital

    Copenhagen, 2400, Denmark

  • CAP Can Bou

    Castelldefels, Barcelona, 08860, Spain

  • CAP Corbera

    Barcelona, 08757, Spain

  • CAP El Maresme

    Mataró, Barcelona, 08303, Spain

  • CHRISTUS Spohn Shoreline Hospital

    Corpus Christi, Texas, 78404, United States

  • Carilion Medical Center (Site 080-018)

    Roanoke, Virginia, 24015, United States

  • Central City Clinical Hospital of Ivano-Frankivsk City Council

    Ivano-Frankivsk, 76018, Ukraine

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

    Mar del Plata, Buenos Aires, B7600FYK, Argentina

  • Chulalongkorn University and The HIV-NAT

    Pathum Wan, Bangkok, 10330, Thailand

  • Cleveland Clinic Foundation (Site 207-001)

    Cleveland, Ohio, 44195, United States

  • Clínica Central S.A. (611-028)

    Villa Regina, Río Negro Province, R8336, Argentina

  • Department of Clinical Therapeutics of Alexandra Hospital

    Athens, Attica, 11528, Greece

  • Department of Infectious Diseases

    Aalborg, 9000, Denmark

  • Dept of Critical Care and Pulmonary Medicine, Evangelismos General Hospital

    Athens, Attica, 10676, Greece

  • Henry Ford Health System Site (014-001)

    Detroit, Michigan, 48202, United States

  • Herlev/Gentofte Hospital

    Hellerup, 2900, Denmark

  • Hospital General Dr. Aurelio Valdivieso

    Oaxaca City, OA, 68050, Mexico

  • Hospital General Dr. Manuel Gea Gonzáles

    Mexico City, Mexico City, 14080, Mexico

  • Hospital General de Agudos JM Ramos Mejia

    Buenos Aires, C1221ADC, Argentina

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hvidovre University Hospital, Department of Infectious Diseases

    Hvidovre, 2650, Denmark

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Instituto Medico Platense

    La Plata, Buenos Aires, B1900AVG, Argentina

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, Mexico City, 14080, Mexico

  • Instituto Nacional de Enfermedades Respiratorias Ismael Cosió Villegas

    Mexico City, Mexico City, 14080, Mexico

  • Intermountain Medical Center (211-001)

    Murray, Utah, 84107, United States

  • Joint Clinical Research Center (JCRC)

    Kampala, Uganda

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

    Khon Kaen, 40002, Thailand

  • Kolding Sygehus

    Kolding, 6000, Denmark

  • Laiko Athens General Hospital

    Athens, Attica, 11527, Greece

  • Lira Regional Referral Hospital

    Lira, Uganda

  • MRC/UVRI & LSHTM Uganda Research Unit

    Entebbe, Uganda

  • Makerere University Lung Institute (Site 634-604)

    Kampala, Uganda

  • Masaka Regional Referral Hospital

    Masaka, Uganda

  • Odense University Hospital

    Odense, C, 5000, Denmark

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

    Hershey, Pennsylvania, 17033, United States

  • Rigshospitalet, CHIP

    Copenhagen, 2100, Denmark

  • Rocky Mountain Regional VA Medical Center (074-010)

    Aurora, Colorado, 80045, United States

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Salem VA Medical Center (074-014)

    Salem, Virginia, 24153, United States

  • San Francisco VAMC (Site 074-002)

    San Francisco, California, 94121, United States

  • Siriraj Hospital (Site 613-002)

    Bangkok Noi, Bangkok, 10700, Thailand

  • Southern Arizona VA Healthcare System (074-009)

    Tucson, Arizona, 85723, United States

  • St. Francis Hospital, Nsambya

    Kampala, Uganda

  • St. Vincent's Hospital

    Sydney, New South Wales, 2010, Australia

  • Stanford University Hospital & Clinics (Site 203-003)

    Palo Alto, California, 94305, United States

  • Swedish Hospital First Hill

    Seattle, Washington, 98122, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

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

    Charlottesville, Virginia, 22908, United States

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

    Lima, 15012, Peru

  • University College London Hospitals

    London, WC1E 6JB, United Kingdom

  • University Malaya Medical Centre (Site 612-501)

    Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

  • VA Northern California Health Care System (074-023)

    Mather, California, 95655, United States

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Other studies related to the condition(s) this trial covers.