CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,307 enrolled
Drug / intervention
LY3819253 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04427501
NCT04427501Phase 3Completed

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

Eli Lilly and Company·interventional·Posted Jun 11, 2020·Updated Apr 11, 2024

In Brief

A Phase 3 clinical trial evaluating LY3819253, LY3832479, and 2 other interventions for COVID-19. Completed, enrolled 3,307 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 11, 2020
Enrollment StartJun 17, 2020
Primary CompletionFeb 21, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.1 years ago

Interventions

LY3819253drug

Administered IV

LY3832479drug

Administered IV

LY3853113drug

Administered IV

Placebodrug

Administered IV