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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
No longer available
CT.gov ID
NCT04603651
Collaborator
AbCellera Biologics Inc. (Industry)

Study Details

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access Information for Physicians for Bamlanivimab (LY3819253) Emergency Investigational New Drug [EIND]

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Eli Lilly and Company
    • AbCellera Biologics Inc.

    Investigators

    • Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04603651
    Other Study ID Numbers:
    • 18165
    • J2X-MC-Y001
    First Posted:
    Oct 27, 2020
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 15, 2022
    Additional relevant MeSH terms:
    COVID-19
    Bamlanivimab

    Study Results

    No Results Posted as of Aug 18, 2022