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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411628
• Other study ID #: 17823
• Secondary ID: J2W-MC-PYAA
• Status: Completed
• Phase: Phase 1
• Start date: May 28, 2020
• Est. completion date: August 26, 2020

Study information

• Verified date: November 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 26, 2020
• Est. primary completion date: August 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• LY3819253
Administered IV.
• Placebo
Administered IV.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
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	Cedars Sinai Medical Center	Los Angeles	California
United States	Alexandria Center for Life - NYC/ NYCEDC	New York	New York
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Temple Univ School of Med	Philadelphia	Pennsylvania
United States	Veterans Affairs Medical Center San Diego	San Diego	California
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	AbCellera Biologics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through Day 60
Secondary	Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29	Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29.	Day 29
Secondary	Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load	Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load.	Baseline, Day 29
Secondary	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.	Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose
Secondary	Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance	Pharmacodynamics (PD): Time to SARS-CoV-2 clearance.	Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose

External Links

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