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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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT05092581
Collaborator
(none)
2
Enrollment
2
Locations
1
Arm
5.7
Actual Duration (Months)
1
Patient Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 16, 2021
Actual Primary Completion Date :
Jun 9, 2022
Actual Study Completion Date :
Jun 9, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: casirivimab+imdevimab

Drug: casirivimab+imdevimab
Single dose weight-based equivalent administered intravenously (IV)
Other Names:
  • REGN-COV2
  • REGN10933
  • REGN10987
  • REGEN-COV™
  • Ronapreve™

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Concentrations of casirivimab+imdevimab in serum over time [Through day 169]

    2. Proportion of patients with treatment-emergent serious adverse events (SAEs) [Through day 29]

    3. Proportion of patients with infusion-related reactions [Through day 4]

    4. Proportion of patients with hypersensitivity reactions [Through day 29]

    Secondary Outcome Measures

    1. Incidence of anti-drug antibodies (ADA) to casirivimab+imdevimab over time [Through day 169]

    2. Incidence of neutralizing antibodies (NAb) to casirivimab+imdevimab over time [Through day 169]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Minute to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 State University of New York at Stony Brook Stony Brook New York United States 11794
    2 Le Bonheur Children's Hospital Memphis Tennessee United States 38103

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05092581
    Other Study ID Numbers:
    • R10933-10987-COV-2114
    • 2021-004535-84
    First Posted:
    Oct 25, 2021
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Regeneron Pharmaceuticals
    Coronavirus disease 2019 (COVID-19)
    Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
    coronavirus
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jul 29, 2022