NCT04497987

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

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LY3819253 Alone and in Combination With LY3832479 in Preventing SARS-CoV-2 Infection and COVID-19 in Skilled Nursing and Assisted Living Facility Residents and Staff; a NIAID and Lilly Collaborative Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,180 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19
• SARS-CoV2

Interventions

Type	Name	Description
DRUG	Bamlanivimab	Administered IV.
DRUG	Placebo	Administered IV.
DRUG	Etesevimab	Administered IV.

Timeline

• Start date: 2020-08-02
• Primary completion: 2021-01-16
• Completion: 2021-05-20
• First posted: 2020-08-04
• Last updated: 2022-02-04
• Results posted: 2022-02-04

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study