NCT04427501

A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness

A Randomized, Double-blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3,307 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure how well LY3819253 and LY3832479 work against the virus that causes COVID-19. LY3819253 and LY3832479 will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 weeks and includes one required visit to the study site, with the remainder of assessments performed in the home or by phone. Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 22), open-label addendum to evaluate the pharmacokinetics and safety of LY3819253 and LY3832479. Enrollment began on March 31, 2021, and completed on September 24, 2021. Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 23), open-label addendum to evaluate the pharmacokinetics and safety of LY3853113. Enrollment began on August 19, 2022, and completed on February 21, 2023.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	LY3819253	Administered IV
DRUG	LY3832479	Administered IV
DRUG	LY3853113	Administered IV
DRUG	Placebo	Administered IV

Timeline

• Start date: 2020-06-17
• Primary completion: 2023-02-21
• Completion: 2023-02-21
• First posted: 2020-06-11
• Last updated: 2024-04-11
• Results posted: 2022-03-07

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study