Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19
NCT ID: NCT04603651
Last Updated: 2023-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Bamlanivimab
Administered intravenously (IV).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease
12 Years
ALL
No
Sponsors
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AbCellera Biologics Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Contact Lilly at 1-800-LillyRx (1-800-545-5979)
Role: STUDY_DIRECTOR
Eli Lilly and Company
References
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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.
Other Identifiers
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J2X-MC-Y001
Identifier Type: OTHER
Identifier Source: secondary_id
18165
Identifier Type: -
Identifier Source: org_study_id
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