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COVID-19 Administration of Single-Dose Subcutaneous Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies Casirivimab and Imdevimab in High-Risk Pediatric Participants Under 12 Years of Age

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT04992273
Collaborator
(none)
7
Enrollment
7
Locations
4
Arms
8.6
Actual Duration (Months)
1
Patient Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to characterize the concentrations of casirivimab+imdevimab in serum over time after a single subcutaneous (SC) administration

The secondary objectives of the study are:

  • To assess the safety and tolerability of SC or single administration of casirivimab+imdevimab

  • To assess the occurrence of grade ≥3 injection site reactions and grade ≥3 hypersensitivity reactions, in participants treated with SC doses of casirivimab+imdevimab

  • To assess the immunogenicity of casirivimab+imdevimab

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2A, Open-Label Study Assessing Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Single-Dose Subcutaneous Anti- Spike(s) SARS-COV-2 Monoclonal Antibodies (Casirivimab and Imdevimab) in High-Risk Pediatric Subjects Under 12 Years of Age
Actual Study Start Date :
Sep 13, 2021
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ≥20 kg to <40 kg

SC administration

Drug: casirivimab+imdevimab
Single dose administered based on weight
Other Names:
  • REGN10933-10987
  • REGN-COV2
  • REGEN-COV™
  • RONAPREVE™

    		•
    Experimental: ≥10 kg to <20 kg

    SC administration

    Drug: casirivimab+imdevimab
    Single dose administered based on weight
    Other Names:
  • REGN10933-10987
  • REGN-COV2
  • REGEN-COV™
  • RONAPREVE™

    		•
    Experimental: ≥5 kg to <10 kg

    SC administration

    Drug: casirivimab+imdevimab
    Single dose administered based on weight
    Other Names:
  • REGN10933-10987
  • REGN-COV2
  • REGEN-COV™
  • RONAPREVE™

    		•
    Experimental: ≥3 kg to <5 kg

    SC administration

    Drug: casirivimab+imdevimab
    Single dose administered based on weight
    Other Names:
  • REGN10933-10987
  • REGN-COV2
  • REGEN-COV™
  • RONAPREVE™

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Concentrations of casirivimab+imdevimab in serum over time. [Up to 24 weeks]

    Secondary Outcome Measures

    1. Number of participants with treatment-emergent adverse events (TEAEs) [Through end of study, approximately 24 weeks]

    2. Severity of TEAEs [Through end of study, approximately 24 weeks]

    3. Number of participants with grade ≥3 injection site reactions [Through Day 4]

    4. Number of participants with grade ≥3 hypersensitivity reactions [Through Day 4]

    5. Immunogenicity as measured by anti-drug antibodies (ADA) to casirivimab over time [Up to 24 weeks]

    6. Immunogenicity as measured by ADA to imdevimab over time [Up to 24 weeks]

    7. Immunogenicity as measured by neutralizing antibodies (NAb) to casirivimab over time [Up to 24 weeks]

    8. Immunogenicity as measured by NAb to imdevimab over time [Up to 24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Minute to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    1. Is <12 years of age and ≥3 kg to <40 kg at the time parental/guardian consent is signed

    2. Has at least one risk factor for developing severe COVID-19 if they were to become infected, such as:

    3. Obesity (BMI [kg/m2] ≥95th percentile for age and sex based on CDC growth charts)

    4. Cardiovascular disease

    5. Chronic lung disease

    6. Type 1 or type 2 diabetes mellitus

    7. Chronic kidney disease, including those on dialysis

    8. Chronic liver disease

    9. Immunocompromised or immunodeficient, based on Investigator's assessment (examples include cancer treatment, bone marrow or organ transplantation, immune deficiencies, HIV infection, sickle cell anemia, thalassemia, and prolonged use of immune-weakening medications)

    10. Medical complexities (examples include any underlying genetic condition, neurologic condition, metabolic condition, or congenital heart disease)

    11. Any other condition deemed by the Investigator to be a risk factor for severe COVID-19

    Key Exclusion Criteria:

    1. Has positive diagnostic test for SARS-CoV-2 infection from a sample collected during screening ≤7 days prior to study drug administration Note: The sample for the test should be collected ≤7 days within study drug administration, and the result should be reviewed and confirmed negative prior to dosing. Historical records will not be accepted.

    2. Has active respiratory or non-respiratory symptoms consistent with COVID-19 in the opinion of the Investigator

    3. Has subject-reported clinical history of COVID-19, as determined by Investigator, within the last 90 days

    4. Has subject-reported history of prior Emergency Use Authorization (EUA)/approved positive diagnostic test for SARSCoV-2 infection within the last 90 days

    5. Is currently hospitalized or was hospitalized for >24 hours for any reason within 14 days of the screening visit

    6. Prior use (within 90 days prior to study drug administration) or current use of any investigational, authorized, or approved passive antibody for prophylaxis of SARS-CoV-2 infection, including convalescent plasma, convalescent sera, hyperimmune globulin, or other monoclonal antibodies (eg, bamlanivimab and etesevimab, sotrovimab)

    7. Has initiated vaccination for SARS-CoV-2 with an investigational or approved vaccine, but has not completed the vaccine schedule as recommended by the vaccine manufacturer.

    8. Plans to receive an investigational or approved SARS-CoV-2 vaccine within 90 days after study drug administration, or per the recommended time frame from the current Centers for Disease Control vaccination guidelines (CDC, 2021b)

    NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Advanced Research Center, Inc Anaheim California United States 92805
    2 Batchelor's Children's Research Institute Miami Florida United States 33136
    3 Jacobi Medical Center Bronx New York United States 10461
    4 Stony Brook University Hospital Stony Brook New York United States 11794
    5 SUNY Upstate Medical University Syracuse New York United States 13210
    6 Coastal Pediatric Research Charleston South Carolina United States 29414
    7 Regeneron Research Site Richmond Virginia United States 23226

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05149300
    Other Study ID Numbers:
    • R10933-10987-COV-2121
    • 2021-004590-30
    • NCT05149300
    First Posted:
    Aug 5, 2021
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Regeneron Pharmaceuticals
    Coronavirus disease 2019 (COVID-19)
    Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
    coronavirus
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jul 29, 2022