CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 314 enrolled
Drug / intervention
LY3819253 +2 morebiological
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/NCT05780268
NCT05780268Phase 3Completed
CompareCT.gov

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H1: LY3819253 (LY-CoV555))

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Mar 22, 2023·Updated Dec 27, 2023

In Brief

A Phase 3 clinical trial evaluating LY3819253, Placebo, and 1 other intervention for COVID-19. Completed, enrolled 314 participants across 57 sites in 4 countries.

Detailed Summary

This study looks at the safety and effectiveness of LY3819253 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either LY3819253 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesDenmark, Singapore, Spain, United States
CollaboratorsInternational Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Eli Lilly and Company, University of Minnesota

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMar 22, 2023
Enrollment StartAug 5, 2020
Primary CompletionFeb 1, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.3 years ago

Interventions

LY3819253biological

LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2

Placebobiological

Commercially available 0.9% sodium chloride solution

Remdesivirbiological

Antiviral agent