Clinical trial NCT04992273: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Keywords: Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
coronavirus
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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:

   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:

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

Primary outcomes:
measure: Concentrations of Casirivimab+Imdevimab in Serum Over Time.
timeFrame: Day 0 and Day 14
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Through end of study, approximately 24 weeks
measure: Number of Participants With Indicated Severity of TEAEs
timeFrame: Through end of study, approximately 24 weeks
measure: Number of Participants With Grade ≥3 Injection Site Reactions
timeFrame: Through Day 4
measure: Number of Participants With Grade ≥3 Hypersensitivity Reactions
timeFrame: Through Day 4
measure: Number of Participants With Indicated Immunogenicity as Measured by Anti-drug Antibodies (ADA) to Casirivimab Over Time
timeFrame: Up to 24 weeks
measure: Number of Participants With Indicated Immunogenicity as Measured by ADA to Imdevimab Over Time
timeFrame: Up to 24 weeks
measure: Immunogenicity as Measured by Neutralizing Antibodies (NAb) to Casirivimab Over Time
timeFrame: Up to 24 weeks
measure: Immunogenicity as Measured by NAb to Imdevimab Over Time
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Research Center, Inc
state: California
city: Miami
country: United States
facility: Batchelor's Children's Research Institute
state: Florida
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Richmond
country: United States
facility: Regeneron Research Site
state: Virginia
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: