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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04992273
• Other study ID #: R10933-10987-COV-2121
• Secondary ID: 2021-004590-30
• Status: Terminated
• Phase: Phase 2
• Start date: September 13, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: March 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Other known NCT identifiers

• NCT05149300

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• casirivimab+imdevimab
Single dose administered based on weight

Locations

Country	Name	City	State
United States	Advanced Research Center, Inc	Anaheim	California
United States	Jacobi Medical Center	Bronx	New York
United States	Coastal Pediatric Research	Charleston	South Carolina
United States	Batchelor's Children's Research Institute	Miami	Florida
United States	Regeneron Research Site	Richmond	Virginia
United States	Stony Brook University Hospital	Stony Brook	New York
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations of Casirivimab+Imdevimab in Serum Over Time.	Concentrations reported in milligrams per Liter (mg/L)	Day 0 and Day 14
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)		Through end of study, approximately 24 weeks
Secondary	Number of Participants With Indicated Severity of TEAEs	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.	Through end of study, approximately 24 weeks
Secondary	Number of Participants With Grade =3 Injection Site Reactions		Through Day 4
Secondary	Number of Participants With Grade =3 Hypersensitivity Reactions		Through Day 4
Secondary	Number of Participants With Indicated Immunogenicity as Measured by Anti-drug Antibodies (ADA) to Casirivimab Over Time		Up to 24 weeks
Secondary	Number of Participants With Indicated Immunogenicity as Measured by ADA to Imdevimab Over Time		Up to 24 weeks
Secondary	Immunogenicity as Measured by Neutralizing Antibodies (NAb) to Casirivimab Over Time		Up to 24 weeks
Secondary	Immunogenicity as Measured by NAb to Imdevimab Over Time		Up to 24 weeks