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Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19

Primary Purpose

COVID-19

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Bamlanivimab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for COVID-19

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Reside in a country where there are ongoing Lilly-sponsored clinical trials (currently this is only the United States)
  • Present within 10 days of symptom onset
  • Have severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) confirmed by reverse transcription polymerase chain reaction (RT-PCR) within the last three days
  • Participants greater than or equal to (≥) 65 years of age OR

  • Participants ≥ 12 years of age who weigh at least 40 kilograms AND have at least one of the following:

    • Cancer
    • Chronic kidney disease
    • Chronic obstructive pulmonary disease (COPD) or other chronic lung disease
    • Immunocompromised state (weakened immune system or on immunomodulatory medications)
    • Obesity (body mass index [BMI] of 35 or higher)
    • Serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies
    • Sickle cell disease
    • Diabetes mellitus (Types 1 or 2)

Exclusion Criteria:

  • Require hospitalization greater than (>) 24 hours or hospice care. Residents in long term care or skilled nursing facilities that meet the inclusion criteria and are not on mechanical ventilation will be considered
  • Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 23, 2020
    Last Updated
    September 29, 2023
    Sponsor
    Eli Lilly and Company
    Collaborators
    AbCellera Biologics Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04603651
    Brief Title
    Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19
    Official Title
    Expanded Access Information for Physicians for Bamlanivimab (LY3819253) Emergency Investigational New Drug [EIND]
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    September 15, 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
    Eli Lilly and Company
    Collaborators
    AbCellera Biologics Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

    6. Conditions and Keywords

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

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Bamlanivimab
    Other Intervention Name(s)
    LY3819253, LY-CoV555
    Intervention Description
    Administered intravenously (IV).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Eligibility Criteria
    Inclusion Criteria: Reside in a country where there are ongoing Lilly-sponsored clinical trials (currently this is only the United States) Present within 10 days of symptom onset Have severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) confirmed by reverse transcription polymerase chain reaction (RT-PCR) within the last three days Participants greater than or equal to (≥) 65 years of age OR Participants ≥ 12 years of age who weigh at least 40 kilograms AND have at least one of the following: Cancer Chronic kidney disease Chronic obstructive pulmonary disease (COPD) or other chronic lung disease Immunocompromised state (weakened immune system or on immunomodulatory medications) Obesity (body mass index [BMI] of 35 or higher) Serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies Sickle cell disease Diabetes mellitus (Types 1 or 2) Exclusion Criteria: Require hospitalization greater than (>) 24 hours or hospice care. Residents in long term care or skilled nursing facilities that meet the inclusion criteria and are not on mechanical ventilation will be considered Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Contact Lilly at 1-800-LillyRx (1-800-545-5979)
    Organizational Affiliation
    Eli Lilly and Company
    Official's Role
    Study Director

    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

    Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19

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