A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff
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.
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