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

Lilly

Status

Conditions: COVID-19

Treatments: Drug: Bamlanivimab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04603651

18165

J2X-MC-Y001 (Other Identifier)

Details and patient eligibility

About

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

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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