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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Bamlanivimab (Part 1) 		Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab.
  • Drug: Bamlanivimab
    Administered IV.
    Other names:
    • LY-CoV555
    • LY3819253
Placebo Comparator
Placebo (Part 1) 		Participants received single IV infusion of Placebo.
  • Drug: Placebo
    Administered IV.
Experimental
Bamlanivimab (Part 2-Prevention) 		Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
  • Drug: Bamlanivimab
    Administered IV.
    Other names:
    • LY-CoV555
    • LY3819253
Experimental
Bamlanivimab + Etesevimab (Part 2-Prevention) 		Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
  • Drug: Bamlanivimab
    Administered IV.
    Other names:
    • LY-CoV555
    • LY3819253
  • Drug: Etesevimab
    Administered IV.
    Other names:
    • LY-CoV016
    • LY3832479
Placebo Comparator
Placebo Comparator: Placebo (Part 2-Prevention) 		Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
  • Drug: Placebo
    Administered IV.
Experimental
Bamlanivimab (Part 2 - Treatment) 		Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
  • Drug: Bamlanivimab
    Administered IV.
    Other names:
    • LY-CoV555
    • LY3819253
Experimental
Bamlanivimab + Etesevimab (Part 2- Treatment) 		Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
  • Drug: Bamlanivimab
    Administered IV.
    Other names:
    • LY-CoV555
    • LY3819253
  • Drug: Etesevimab
    Administered IV.
    Other names:
    • LY-CoV016
    • LY3832479
Experimental
Bamlanivimab (Part 3) 		Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record. [Participants received single IV infusion of 700 mg bamlanivimab.]
  • Drug: Bamlanivimab
    Administered IV.
    Other names:
    • LY-CoV555
    • LY3819253
Experimental
Bamlanivimab + Etesevimab (Part 3) 		Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record. [Participants received single IV infusion of 700 mg bamlanivimab given with 1400 mg etesevimab.]
  • Drug: Bamlanivimab
    Administered IV.
    Other names:
    • LY-CoV555
    • LY3819253
  • Drug: Etesevimab
    Administered IV.
    Other names:
    • LY-CoV016
    • LY3832479

Recruiting Locations

More Details

NCT ID
NCT04497987
Status
Completed
Sponsor
Eli Lilly and Company

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.