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
Condition: COVID-19; SARS-CoV2
MeSH terms: COVID-19
Intervention: Bamlanivimab; Placebo; Etesevimab
Intervention description: Administered IV.; Administered IV.; Administered IV.
Intervention MeSH terms: Bamlanivimab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prevention

Summary:

      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.
    

Eligibility 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