Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19
- Conditions
- COVID-19
- Registration Number
- NCT04603651
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
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)
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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
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Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method