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.
Drug: LY3819253
Administered IV.
Other Name: Array
Drug: Placebo
Administered IV.
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.
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
Temple Univ School of Med
Philadelphia, Pennsylvania, United States
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director
Eli Lilly and Company