A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19
Completed · Phase 1 · Has a placebo group
Conditions studied: COVID-19
In brief
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.
Key facts
- Study ID
- NCT04411628
- Run by
- Eli Lilly and Company
- People needed
- 26
- Starts
- 2020-05-28
- Expected to finish
- 2020-08-26
- Last updated by the study team
- 2021-11-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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