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

NCT04992273 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: R10933-10987-COV-21212021-004590-30
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 7

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

Conditions

COVID-19

Keywords

Coronavirus disease 2019 (COVID-19); Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2); coronavirus

Outcome Measures

Primary Outcomes (1)

• Concentrations of Casirivimab+Imdevimab in Serum Over Time.

  Concentrations reported in milligrams per Liter (mg/L)

  Day 0 and Day 14

Secondary Outcomes (8)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Through end of study, approximately 24 weeks

• Number of Participants With Indicated Severity of TEAEs

  Through end of study, approximately 24 weeks

• Number of Participants With Grade ≥3 Injection Site Reactions

  Through Day 4

• Number of Participants With Grade ≥3 Hypersensitivity Reactions

  Through Day 4

• Number of Participants With Indicated Immunogenicity as Measured by Anti-drug Antibodies (ADA) to Casirivimab Over Time

  Up to 24 weeks

Study Arms (4)

≥20 kg to <40 kg

EXPERIMENTAL

SC administration

Drug: casirivimab+imdevimab

≥10 kg to <20 kg

EXPERIMENTAL

SC administration

Drug: casirivimab+imdevimab

≥5 kg to <10 kg

EXPERIMENTAL

SC administration

Drug: casirivimab+imdevimab

≥3 kg to <5 kg

EXPERIMENTAL

SC administration

Drug: casirivimab+imdevimab

Interventions

casirivimab+imdevimab DRUG

Single dose administered based on weight

Also known as: REGN10933-10987, REGN-COV2, REGEN-COV™, RONAPREVE™

≥10 kg to <20 kg; ≥20 kg to <40 kg; ≥3 kg to <5 kg; ≥5 kg to <10 kg

Eligibility Criteria

• Age: 1 Minute - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• Obesity (BMI \[kg/m2\] ≥95th percentile for age and sex based on CDC growth charts)
• Cardiovascular disease
• Chronic lung disease
• Type 1 or type 2 diabetes mellitus
• Chronic kidney disease, including those on dialysis
• Chronic liver disease
• 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)
• Medical complexities (examples include any underlying genetic condition, neurologic condition, metabolic condition, or congenital heart disease)
• Any other condition deemed by the Investigator to be a risk factor for severe COVID-19

You may not qualify if:

• 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)

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (7)

Advanced Research Center, Inc

Anaheim, California, 92805, United States

Location

Batchelor's Children's Research Institute

Miami, Florida, 33136, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Coastal Pediatric Research

Charleston, South Carolina, 29414, United States

Location

Regeneron Research Site

Richmond, Virginia, 23226, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

casirivimab and imdevimab drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The study was terminated early due to emerging SARS-CoV-2 variants impacting susceptibility to the study drug. The early termination was not due to safety findings.

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 5, 2021
• Study Start: September 13, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 20, 2025
• Results First Posted: March 6, 2023

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (7)