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

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Drug: LY3819253; Drug: Placebo

• Registration Number: NCT04411628
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-05-28
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-02
• Primary Completion: 2020-08-26
• Study Completion: 2020-08-26
• Status Verified: 2021-11
• Results First Submitted: 2021-11-01
• Results First Submitted QC: 2021-11-01
• Results First Posted: 2021-11-09
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3819253	LY3819253	Participants received single doses of 700 milligrams (mg), 2800 mg or 7000 mg LY3819253 administered as intravenous infusion.
Placebo	Placebo	Participants received single dose of Placebo as intravenous infusion.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Day 60	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29	Day 29	Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29.
Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC	Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose	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.
Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load	Baseline, Day 29	Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load.
Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance	Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose	Pharmacodynamics (PD): Time to SARS-CoV-2 clearance.

Trial Locations

Locations (11)

Temple Univ School of Med; 🇺🇸 Philadelphia, Pennsylvania, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Massachusetts Medical Center; 🇺🇸 Worcester, Massachusetts, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Alexandria Center for Life - NYC/ NYCEDC; 🇺🇸 New York, New York, United States

Unified Research Enterprise Brody School of Medicine at ECU; 🇺🇸 Greenville, North Carolina, United States

Veterans Affairs Medical Center San Diego; 🇺🇸 San Diego, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Quality Clinical Research, Inc.; 🇺🇸 Omaha, Nebraska, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States