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Antibody shield for the vulnerable: COVID-19 prevention trial in immunocompromised

NCT ID NCT05074433

Prevention Sponsor: Regeneron Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a combination of antibodies (casirivimab+imdevimab) could prevent COVID-19 in people with weakened immune systems, such as transplant recipients or cancer patients. Participants received either the antibodies or a placebo as a shot under the skin. The trial was stopped early and enrolled only 66 people, so the results are not conclusive.

What this could mean

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

Active substance
casirivimab+imdevimab (antibody combination)
What this could lead to
If it worked, this could offer a way to prevent COVID-19 in people with weakened immune systems who don't respond well to vaccines.
What could go wrong
The trial was terminated early with only 66 participants, so results are limited. The antibodies may not work against new virus variants.

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

66 people

The number who actually took part.

Started

Oct 2021

Finished

May 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

12 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.

Key Inclusion Criteria: 1. Meets ≥1 of the following criteria: * Is immunocompromised, including people with transplant, who have cancer, primary immunodeficiencies, HIV, rheumatological disease, autoimmune disease, multiple sclerosis OR * Currently taking immunosuppressant drugs 2. Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive full course of vaccine 3. Has documented negative serology/antibody response in an anti-SARS-CoV-2 spike protein IgG clinical test or ≤50 U/mL on the Elecsys® SARS-CoV-2 S Total Ig test 4. Tested negative for the COVID-19 virus within 72 hours prior to randomization Key Exclusion Criteria: 1. Weighs \<40 kg (only applies to participants ≥12 to \<18 years of age) 2. Has any signs or symptoms consistent with COVID-19 3. Past COVID-19 infection within 90 days prior to randomization 4. Planned use of any investigational, authorized, or approved vaccine for COVID-19 within 90 days of the last dose of study drug 5. Prior, current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any COVID-19 treatment 6. Is planned to begin immunoglobulin (IVIG) or immunoglobulin (SCIG) therapy, is planned to have a change to existing IVIG or SCIG, or has been on a chronic stable dose of their IVIG or SCIG regimen for less than 90 days prior to screening 7. Has any known active acute respiratory infection 8. Has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection 9. Has known allergy or hypersensitivity to components of the study drugs NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply

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Conditions

The condition(s) this trial relates to.

immunodeficiency disease COVID-19 prevention target

As listed by the trial registrant

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

Immunocompromised

Contacts and locations

Locations

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • AppleMed Research Group, LLC

    Miami, Florida, 33126, United States

  • Arthritis and Rheumatic Disease Specialties

    Aventura, Florida, 33180, United States

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Burke Primary Care

    Morganton, North Carolina, 28655, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Central Alabama Research

    Birmingham, Alabama, 35205, United States

  • Central Texas Clinical Research

    Austin, Texas, 78705, United States

  • De La Cruz Research Center, LLC

    Miami, Florida, 33184, United States

  • Elixia COVID-19

    Hollywood, Florida, 33024, United States

  • Florida Medical Clinic, LLC

    Zephyrhills, Florida, 33542, United States

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718, United States

  • Georgetown University

    Washington D.C., District of Columbia, 20007, United States

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois, 60625, United States

  • Holy Name

    Teaneck, New Jersey, 07666, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756, United States

  • Institute of Human Virology

    Baltimore, Maryland, 21201, United States

  • James R Berenson MD Inc.

    West Hollywood, California, 90069, United States

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Laboratory of Clinical Immunology and Microbiology, NIAID

    Bethesda, Maryland, 20892, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Maimonides Cancer Center

    Brooklyn, New York, 11220, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Miami Valley Hospital

    Dayton, Ohio, 45409, United States

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Penn Prevention Clinical Research Site

    Philadelphia, Pennsylvania, 19104, United States

  • PharmaTex Research, LLC

    Amarillo, Texas, 79109, United States

  • Regeneron Study Site

    Long Beach, California, 90806, United States

  • Regeneron Study Site

    Los Angeles, California, 90033, United States

  • Regeneron Study Site

    Stanford, California, 94305, United States

  • Regeneron Study Site

    North Haven, Connecticut, 06473-2195, United States

  • Regeneron Study Site

    Atlanta, Georgia, 30322, United States

  • Regeneron Study Site

    Marietta, Georgia, 30060, United States

  • Regeneron Study Site

    Boston, Massachusetts, 02115, United States

  • Regeneron Study Site

    New York, New York, 10032-3729, United States

  • Regeneron Study Site

    Rochester, New York, 14642, United States

  • Regeneron Study Site

    Syracuse, New York, 13210, United States

  • Regeneron Study Site

    Cleveland, Ohio, 44195, United States

  • Regeneron Study Site

    Providence, Rhode Island, 02903, United States

  • Regeneron Study Site

    Richmond, Virginia, 23219, United States

  • Regeneron Study Site

    Seattle, Washington, 98109, United States

  • Regeneron Study Site

    Cuauhtémoc, Mexico City, 6700, Mexico

  • Regeneron Study Site 2

    New York, New York, 10065, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13215, United States

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • Swedish Medical Center- First Hill

    Seattle, Washington, 98122, United States

  • Synergy Group Medical,LLC

    Houston, Texas, 77087, United States

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • Therapeutic Concepts, PA

    Houston, Texas, 77004, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • Tulane University

    New Orleans, Louisiana, 70112, United States

  • University Of Colorado

    Aurora, Colorado, 80045, United States

  • University of California

    Sacramento, California, 95817, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53792, United States

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305, United States

More trials for these conditions

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