E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051905 |
E.1.2 | Term | Coronavirus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To characterize the concentrations of casirivimab+imdevimab in serum over time after a single subcutaneous (SC) administration |
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E.2.2 | Secondary objectives of the trial |
• To assess the safety and tolerability of SC 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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: a. Obesity (BMI [kg/m2] ≥95th percentile for age and sex based on CDC growth charts) b. Cardiovascular disease c. Chronic lung disease d. Type 1 or type 2 diabetes mellitus e. Chronic kidney disease, including those on dialysis f. Chronic liver disease g. 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) h. Medical complexities (examples include any underlying genetic condition, neurologic condition, metabolic condition, or congenital heart disease) i. Any other condition deemed by the Investigator to be a risk factor for severe COVID-19
Other Protocol Defined Inclusion Criteria Apply |
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E.4 | Principal 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 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)
Other Protocol Defined Exclusion Criteria Apply |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Concentrations of casirivimab+imdevimab in serum over time |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) Number of participants with treatment-emergent adverse events (TEAEs) 2) Number of participants with severity of TEAEs 3) Number of participants with grade ≥3 injection site reactions 4) Number of participants with grade ≥3 hypersensitivity reactions 5) Immunogenicity as measured by anti-drug antibodies (ADA) to casirivimab over time 6) Immunogenicity as measured by ADA to imdevimab over time |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Through end of study, approximately 24 weeks 2) Through end of study, approximately 24 weeks 3) Through day 4 4) Through day 4 5) Up to 24 weeks 6) Up to 24 weeks |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 7 |