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

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19, SARS-CoV2

In brief

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.

Key facts

Study ID

NCT04497987

Run by

Eli Lilly and Company

People needed

1180

Starts

2020-08-02

Expected to finish

2021-05-20

Last updated by the study team

2022-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — The 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

Full record on ClinicalTrials.gov

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