The purpose of this study is to evaluate whether LY3819253 given alone and with LY3832479 prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 (COVID-19). Facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure will receive LY3819253, LY3819253 and LY3832479, or placebo via an injection into a vein. Samples will be taken from the nose. Blood samples will be drawn. Participation could last up to 25 weeks and may include up to 19 visits.
Drug: Bamlanivimab
Administered IV.
Other Name: Array
Drug: Placebo
Administered IV.
Drug: Etesevimab
Administered IV.
Other Name: Array
Inclusion Criteria:
- Part 1 and Part 2: Resident or facility staff in a skilled nursing or assisted living
facility with at least one confirmed case of SARS-CoV-2 detection less than or equal
to (≤)7 days prior to randomization
- Are men or non-pregnant women who agree to contraceptive requirements
- Agree to the collection of nasal, mid-turbinate, oropharyngeal, and nasopharyngeal
swabs, and venous blood as specified in the schedule of activities
- Have venous access sufficient to allow intravenous infusions and blood sampling
- The participant or legally authorized representative give signed informed consent
- Part 3 only: Resident or staff in a skilled nursing or assisted living facility who
satisfy at least one of the following at the time of screening
- Are greater than or equal to (≥) 65 years of age
- Have a body mass index (BMI) ≥ 35
- Have chronic kidney disease
- Have type 1 or type 2 diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment, or
- Are ≥ 55 years of age AND have
- cardiovascular disease, OR
- hypertension, OR
- chronic obstructive pulmonary disease or other chronic respiratory disease
- Positive SARS-CoV-2 test and infusion within 10 days of symptom onset, OR positive
SARS-CoV-2 test and infusion within 10 days of testing if asymptomatic
Exclusion Criteria:
- Parts 1 and 2:
- Recovered from confirmed COVID-19 disease or asymptomatic infection
- Prior history of a positive SARS-CoV-2 serology test
- History of convalescent COVID-19 plasma treatment
- Participation in a previous SARS-CoV-2 vaccine trial or received an approved
SARS-CoV-2 vaccine
- Previous receipt of SAR-CoV-2-specific monoclonal antibodies
- Have any serious concomitant systemic disease, condition or disorder that, in the
opinion of the investigator, should preclude participation in this study
Unv of AL Sch of Med Div of Infectious Diseases
Birmingham, Alabama, United States
Care Access Research
Phoenix, Arizona, United States
Allergy and Asthma Clin of NW Ark
Bentonville, Arkansas, United States
Care Access Research LLC
Huntington Beach, California, United States
Alta Bates SMC
Oakland, California, United States
University of Colorado-Anschultz Medical Campus
Aurora, Colorado, United States
NIAID
Miami, Florida, United States
NIAID
Decatur, Georgia, United States
Belmont Village Lincoln Park
Lincoln Park, Illinois, United States
Family Medicine
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Care Access Rch Lake Charles
Lake Charles, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
NIAID - National Institute of Allergy & Infectious Diseases
Bethesda, Maryland, United States
Care Access
Boston, Massachusetts, United States
St. Paul IDA-CARe
Saint Paul, Minnesota, United States
Care Access
Jackson, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Hospital & Medical Center
Omaha, Nebraska, United States
Care Access Research - Bronx
Bronx, New York, United States
NIAD
Chapel Hill, North Carolina, United States
Valley Medical Primary Care
Centerville, Ohio, United States
Univ of Cin College of Med
Cincinnati, Ohio, United States
OSU Med Intl Med Houston Ctr
Tulsa, Oklahoma, United States
Donahoe Manor
Bedford, Pennsylvania, United States
Belmont Village, West Univ
Houston, Texas, United States
Burke Internal Medicine and Research
Burke, Virginia, United States
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director
Eli Lilly and Company