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

NCT ID: NCT04992273

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-13
• Study Completion Date: 2022-06-01

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

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

≥20 kg to <40 kg

SC administration

Group Type: EXPERIMENTAL

casirivimab+imdevimab

Intervention Type: DRUG

Single dose administered based on weight

≥10 kg to <20 kg

SC administration

Group Type: EXPERIMENTAL

casirivimab+imdevimab

Intervention Type: DRUG

Single dose administered based on weight

≥5 kg to <10 kg

SC administration

Group Type: EXPERIMENTAL

casirivimab+imdevimab

Intervention Type: DRUG

Single dose administered based on weight

≥3 kg to <5 kg

SC administration

Group Type: EXPERIMENTAL

casirivimab+imdevimab

Intervention Type: DRUG

Single dose administered based on weight

Interventions

casirivimab+imdevimab

Single dose administered based on weight

Intervention Type: DRUG

Other Intervention Names

REGN10933-10987; REGN-COV2; REGEN-COV™; RONAPREVE™

Eligibility Criteria

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:

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

2. Cardiovascular disease

3. Chronic lung disease

4. Type 1 or type 2 diabetes mellitus

5. Chronic kidney disease, including those on dialysis

6. Chronic liver disease

7. 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)

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

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

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)

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Advanced Research Center, Inc

Anaheim, California, United States

Batchelor's Children's Research Institute

Miami, Florida, United States

Stony Brook University Hospital

Stony Brook, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

Coastal Pediatric Research

Charleston, South Carolina, United States

Regeneron Research Site

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-004590-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R10933-10987-COV-2121

Identifier Type: -

Identifier Source: org_study_id

NCT05149300

Identifier Type: -

Identifier Source: nct_alias