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Compassionate Use of REGN-COV2 for the Treatment of COVID-19

Primary Purpose

COVID-19

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
REGN10933+REGN10987 combination therapy
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for COVID-19 focused on measuring Post-exposure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 2020
    Last Updated
    September 29, 2023
    Sponsor
    Regeneron Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04617535
    Brief Title
    Compassionate Use of REGN-COV2 for the Treatment of COVID-19
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Regeneron Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    Compassionate Use requests will be considered for individuals who test positive for SARS-CoV-2 and where there is reasonable basis to believe that the patient is infected with a susceptible variant.
    Detailed Description
    Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19
    Keywords
    Post-exposure

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    REGN10933+REGN10987 combination therapy
    Other Intervention Name(s)
    REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™, Ronapreve™
    Intervention Description
    Administered intravenously (IV) single dose

    10. Eligibility

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34473343
    Citation
    Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
    Results Reference
    derived

    Learn more about this trial

    Compassionate Use of REGN-COV2 for the Treatment of COVID-19

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