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

Phase 2

Terminated

Conditions: COVID-19

Interventions: Drug: casirivimab+imdevimab

Registration Number: NCT04992273

Lead Sponsor: Regeneron Pharmaceuticals

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

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 7

Inclusion Criteria

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

Key

Exclusion Criteria

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.
Has active respiratory or non-respiratory symptoms consistent with COVID-19 in the opinion of the Investigator
Has subject-reported clinical history of COVID-19, as determined by Investigator, within the last 90 days
Has subject-reported history of prior Emergency Use Authorization (EUA)/approved positive diagnostic test for SARSCoV-2 infection within the last 90 days
Is currently hospitalized or was hospitalized for >24 hours for any reason within 14 days of the screening visit
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)
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.
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
≥20 kg to <40 kg	casirivimab+imdevimab	SC administration
≥10 kg to <20 kg	casirivimab+imdevimab	SC administration
≥5 kg to <10 kg	casirivimab+imdevimab	SC administration
≥3 kg to <5 kg	casirivimab+imdevimab	SC administration

Primary Outcome Measures

Name	Time	Method
Concentrations of Casirivimab+Imdevimab in Serum Over Time.	Day 0 and Day 14	Concentrations reported in milligrams per Liter (mg/L)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Through end of study, approximately 24 weeks
Number of Participants With Indicated Immunogenicity as Measured by Anti-drug Antibodies (ADA) to Casirivimab Over Time	Up to 24 weeks
Immunogenicity as Measured by Neutralizing Antibodies (NAb) to Casirivimab Over Time	Up to 24 weeks
Immunogenicity as Measured by NAb to Imdevimab Over Time	Up to 24 weeks
Number of Participants With Indicated Immunogenicity as Measured by ADA to Imdevimab Over Time	Up to 24 weeks
Number of Participants With Grade ≥3 Hypersensitivity Reactions	Through Day 4
Number of Participants With Indicated Severity of TEAEs	Through end of study, approximately 24 weeks	Treatment-emergent adverse events (TEAEs) are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. The severity of AEs were graded using version 5.0 of NCI-CTCAE.
Number of Participants With Grade ≥3 Injection Site Reactions	Through Day 4

Trial Locations

Locations (7): Advanced Research Center, Inc
🇺🇸
Anaheim, California, United States
Stony Brook University Hospital
🇺🇸
Stony Brook, New York, United States
SUNY Upstate Medical University
🇺🇸
Syracuse, New York, United States
Batchelor's Children's Research Institute
🇺🇸
Miami, Florida, United States
Jacobi Medical Center
🇺🇸
Bronx, New York, United States
Coastal Pediatric Research
🇺🇸
Charleston, South Carolina, United States
Regeneron Research Site
🇺🇸
Richmond, Virginia, United States