COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19

A Phase 1b, Open-Label, Single Dose Study Assessing the Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19

The primary objectives of the study are:

• To characterize the concentrations of casirivimab+imdevimab in serum over time
• To evaluate the safety and tolerability of casirivimab+imdevimab

The secondary objective of the study is:

• To assess the immunogenicity of casirivimab+imdevimab

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: casirivimab+imdevimab

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • State University of New York at Stony Brook
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Le Bonheur Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Has SARS-CoV-2 positive antigen or molecular diagnostic test ≤72 hours prior to study enrollment Note: historical record of positive result is acceptable as long as the sample was collected ≤72 hours prior to enrollment
2. Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤ 14 days before dosing
3. Hospitalized due to COVID-19
4. Provide informed consent signed by study patient or legally acceptable representative/guardian

Key Exclusion Criteria:

1. In the opinion of the investigator, unlikely to survive for >96 hours from screening
2. Neonates having gestational age of <29 weeks and weight <1.1 kg
3. Receiving extracorporeal membrane oxygenation (ECMO)
4. Has new-onset stroke or seizure disorder during hospitalization
5. Initiated on renal replacement therapy due to COVID-19
6. Has circulatory shock requiring vasopressors on dosing day Note: Patients who require vasopressors for sedation-related hypotension or reasons other than circulatory shock may be eligible in this study
7. Participation in a clinical research study, including any double-blind study, evaluating an investigational product within 30 days and less than 5 half-lives of the investigational product prior to the screening visit
8. Members of the clinical site study team and/or their immediate family

9. Plans to receive an investigational or approved SARS-CoV-2 vaccine within 90 days after study drug administration based on current Centers for Disease Control vaccination guidelines (CDC, 2021). Refer to the latest CDC guidance for any updates.

   Note: Patients who have already completed vaccination prior to study enrollment may be allowed in the study.

10. 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)

Note: Other protocol defined Inclusion/ Exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: casirivimab+imdevimab	Drug: casirivimab+imdevimab; Single dose weight-based equivalent administered intravenously (IV); Other Names: REGN-COV2; REGEN-COV™; Ronapreve™; REGN10933; REGN10987

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentrations of casirivimab+imdevimab in serum over time	Through day 169
Proportion of patients with treatment-emergent serious adverse events (SAEs)	Through day 29
Proportion of patients with infusion-related reactions	Through day 4
Proportion of patients with hypersensitivity reactions	Through day 29

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of anti-drug antibodies (ADA) to casirivimab+imdevimab over time	Through day 169
Incidence of neutralizing antibodies (NAb) to casirivimab+imdevimab over time	Through day 169

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Actual): June 9, 2022
• Study Completion (Actual): June 9, 2022

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: coronavirus; Coronavirus disease 2019 (COVID-19); Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronaviridae Infections; Nidovirales Infections; COVID-19; Coronavirus Infections; casirivimab and imdevimab drug combination; casirivimab; imdevimab
• Other Study ID Numbers: R10933-10987-COV-2114; 2021-004535-84 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• IPD Sharing 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.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No