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

ABSTRACT

ConditionCOVID-19;SARS-CoV2

InterventionDrug Bamlanivimab;Drug Placebo;Drug Etesevimab

Primary outcome:Percentage of Participants With COVID-19

Criteria
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