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

NCT ID: NCT04603651

Last Updated: 2023-10-02

Study Results

Results pending

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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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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

Detailed Description

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Conditions

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COVID-19

Interventions

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Bamlanivimab

Administered intravenously (IV).

Intervention Type DRUG

Other Intervention Names

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LY3819253 LY-CoV555

Eligibility Criteria

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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)

* Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbCellera Biologics Inc.

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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.

Reference Type DERIVED
PMID: 34473343 (View on PubMed)

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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