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

Eli Lilly and Company26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

COVID-19

Interventions

LY3819253DRUG

Administered IV.

PlaceboDRUG

Administered IV.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.

Time frame: Baseline through Day 60

Secondary Outcomes

Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29

Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29.

Time frame: Day 29

Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load

Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load.

Time frame: Baseline, Day 29

Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC

The SARS-CoV-2 viral load was derived from the cycle time (CT) values using a polymerase chain reaction (PCR) assay. Higher CT values indicate a lower viral load.

Time frame: Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose

Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance

Pharmacodynamics (PD): Time to SARS-CoV-2 clearance.

Time frame: Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose

Data from ClinicalTrials.gov

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