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A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19

A Randomized, Placebo-Controlled, Double-Blind, Sponsor Unblinded, Single Ascending Dose, Phase 1 First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous LY3819253 in Participants Hospitalized for COVID-19

NCT04411628•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection into a vein to participants hospitalized with COVID-19. Blood tests will be done to check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it. Participation could last about 8 weeks and may include up to 15 visits in the hospital or the home.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Are hospitalized or in the process of being admitted to hospital and have an initial laboratory determination of current COVID-19 infection less than or equal to (≤)72 hours prior to randomization
•Are men or non-pregnant women
•Women of childbearing potential must agree to use at least one highly effective form of contraception for the entirety of the study
•Agree to the collection of nasopharyngeal swabs and venous blood

Exclusion Criteria

•Require mechanical ventilation or anticipated impending need for mechanical ventilation
•Received convalescent COVID-19 plasma treatment prior to enrollment
•Were resident in a nursing home or long-term care facility immediately prior to current hospitalization
•Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product
•Have an oxygen saturation (SpO2) less than (\<)88 percent (%) while breathing room air at rest at randomization.

Locations (11)

Cedars Sinai Medical Center

Los Angeles, California, United States

Veterans Affairs Medical Center San Diego

San Diego, California, United States

Emory University

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Massachusetts Medical Center

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Alexandria Center for Life - NYC/ NYCEDC

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Unified Research Enterprise Brody School of Medicine at ECU

Greenville, North Carolina, United States

Key Dates

Start Date

May 28, 2020

Primary Completion Date

August 26, 2020

Completion Date

August 26, 2020

Last Updated

November 12, 2021

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

LY3819253

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19

Inclusion Criteria

Exclusion Criteria

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