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
Condition: COVID-19
MeSH terms: COVID-19
Intervention: casirivimab+imdevimab
Intervention description: Single dose administered based on weight
Intervention MeSH terms: Casirivimab and imdevimab drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 1 Minute
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Coronavirus disease 2019 (COVID-19); Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2); coronavirus

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