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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04603651
Expanded Access Status : No longer available
First Posted : October 27, 2020
Last Update Posted : November 18, 2021
Sponsor:
Collaborator:
AbCellera Biologics Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

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
COVID-19 Drug: Bamlanivimab

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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Bamlanivimab
    Administered intravenously (IV).
    Other Names:
    • LY3819253
    • LY-CoV555

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603651


Sponsors and Collaborators
Eli Lilly and Company
AbCellera Biologics Inc.
Investigators
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Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979) Eli Lilly and Company
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04603651    
Other Study ID Numbers: 18165
J2X-MC-Y001 ( Other Identifier: Eli Lilly and Company )
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: November 18, 2021
Last Verified: November 15, 2021
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases