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NCT04603651 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT04603651
Other study ID # 18165
Secondary ID J2X-MC-Y001
Status No longer available
Phase
First received
Last updated

Study information
Verified date September 15, 2023
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 12 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bamlanivimab
Administered intravenously (IV).

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Eli Lilly and Company AbCellera Biologics Inc.
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