A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults
NCT ID: NCT05074433
Last Updated: 2025-10-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
66 participants
INTERVENTIONAL
2021-10-25
2022-05-18
Brief Summary
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The secondary objectives of the study are:
* To evaluate the safety and tolerability of repeated SC injections of casirivimab+imdevimab in the study population
* To characterize concentrations of casirivimab and imdevimab in serum over time
* To assess the immunogenicity of casirivimab and imdevimab
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
TRIPLE
Study Groups
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casirivimab+imdevimab Initial + Q4W
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
casirivimab+imdevimab
Co-administered sequentially subcutaneous (SC)
casirivimab+imdevimab Q4W
SC dose Q4W
casirivimab+imdevimab
Co-administered sequentially subcutaneous (SC)
casirivimab+imdevimab Q12W
SC dose every 12 weeks (Q12W)
casirivimab+imdevimab
Co-administered sequentially subcutaneous (SC)
Placebo
SC dose Q4W
Placebo
Administered SC
Interventions
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casirivimab+imdevimab
Co-administered sequentially subcutaneous (SC)
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
Exclusion Criteria
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
12 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Central Alabama Research
Birmingham, Alabama, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Regeneron Study Site
Long Beach, California, United States
Regeneron Study Site
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California
Sacramento, California, United States
Regeneron Study Site
Stanford, California, United States
James R Berenson MD Inc.
West Hollywood, California, United States
University Of Colorado
Aurora, Colorado, United States
Regeneron Study Site
North Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Elixia COVID-19
Hollywood, Florida, United States
AppleMed Research Group, LLC
Miami, Florida, United States
De La Cruz Research Center, LLC
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Florida Medical Clinic, LLC
Zephyrhills, Florida, United States
Regeneron Study Site
Atlanta, Georgia, United States
Regeneron Study Site
Marietta, Georgia, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Tulane University
New Orleans, Louisiana, United States
Institute of Human Virology
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Laboratory of Clinical Immunology and Microbiology, NIAID
Bethesda, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Regeneron Study Site
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Holy Name
Teaneck, New Jersey, United States
Maimonides Cancer Center
Brooklyn, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Regeneron Study Site
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Regeneron Study Site 2
New York, New York, United States
Regeneron Study Site
Rochester, New York, United States
Regeneron Study Site
Syracuse, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Burke Primary Care
Morganton, North Carolina, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Regeneron Study Site
Cleveland, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Penn Prevention Clinical Research Site
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Regeneron Study Site
Providence, Rhode Island, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
PharmaTex Research, LLC
Amarillo, Texas, United States
Central Texas Clinical Research
Austin, Texas, United States
Therapeutic Concepts, PA
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Synergy Group Medical,LLC
Houston, Texas, United States
Regeneron Study Site
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Regeneron Study Site
Seattle, Washington, United States
Swedish Medical Center- First Hill
Seattle, Washington, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
Regeneron Study Site
Cuauhtémoc, Mexico City, Mexico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-005222-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R10933-10987-COV-2176
Identifier Type: -
Identifier Source: org_study_id
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