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

Lilly

Status and phase: Completed; Phase 1

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: LY3819253

Study type: Interventional

Funder types: Industry

Identifiers

NCT04411628

J2W-MC-PYAA (Other Identifier)

17823

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

LY3819253

Experimental group

Description:

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

Treatment:

Drug: LY3819253

Placebo

Placebo Comparator group

Description:

Participants received single dose of Placebo as intravenous infusion.

Treatment:

Drug: Placebo