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

NCT05092581 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: R10933-10987-COV-21142021-004535-84
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

Study Arms (1)

casirivimab+imdevimab

EXPERIMENTAL

Drug: casirivimab+imdevimab

Interventions

casirivimab+imdevimab DRUG

Single dose weight-based equivalent administered intravenously (IV)

Also known as: REGN-COV2, REGN10933, REGN10987, REGEN-COV™, Ronapreve™

casirivimab+imdevimab

Eligibility Criteria

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

You may qualify if:

• 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
• Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤ 14 days before dosing
• Hospitalized due to COVID-19
• Provide informed consent signed by study patient or legally acceptable representative/guardian

You may not qualify if:

• In the opinion of the investigator, unlikely to survive for \>96 hours from screening
• Neonates having gestational age of \<29 weeks and weight \<1.1 kg
• Receiving extracorporeal membrane oxygenation (ECMO)
• Has new-onset stroke or seizure disorder during hospitalization
• Initiated on renal replacement therapy due to COVID-19
• 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
• 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
• Members of the clinical site study team and/or their immediate family
• 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.
• 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)

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (2)

State University of New York at Stony Brook

Stony Brook, New York, 11794, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

casirivimab and imdevimab drug combination; casirivimab; imdevimab

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: October 25, 2021
• Study Start: December 16, 2021
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: October 14, 2025

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 (2)