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

• Status: Completed
• Trial end date: 2021-05-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborators: AbCellera Biologics Inc.; National Institute of Allergy and Infectious Diseases (NIAID); Shanghai Junshi Bioscience Co., Ltd.

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