A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04411628 |
Recruitment Status :
Completed
First Posted : June 2, 2020
Last Update Posted : October 30, 2020
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: LY3819253 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
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 |
Actual Study Start Date : | May 28, 2020 |
Actual Primary Completion Date : | August 26, 2020 |
Actual Study Completion Date : | August 26, 2020 |
Arm | Intervention/treatment |
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Experimental: LY3819253
LY3819253 administered intravenously (IV).
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Drug: LY3819253
Administered IV.
Other Names:
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Placebo Comparator: Placebo
Placebo administered IV.
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Drug: Placebo
Administered IV. |
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Day 60 ]A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
- Pharmacokinetics (PK): Area Under the Concentration-time Curve (AUC) of LY3819253 [ Time Frame: Baseline through Day 29 ]PK: AUC of LY3819253
- Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load [ Time Frame: Baseline, Day 29 ]PD: Change from Baseline in Viral Load

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04411628
United States, California | |
Cedars Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
Veterans Affairs Medical Center San Diego | |
San Diego, California, United States, 92161 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
University of Massachusetts Medical Center | |
Worcester, Massachusetts, United States, 01655 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Nebraska | |
Quality Clinical Research, Inc. | |
Omaha, Nebraska, United States, 68114 | |
United States, New York | |
Alexandria Center for Life - NYC/ NYCEDC | |
New York, New York, United States, 10016 | |
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 27514 | |
Unified Research Enterprise Brody School of Medicine at ECU | |
Greenville, North Carolina, United States, 27834 | |
United States, Pennsylvania | |
Temple Univ School of Med | |
Philadelphia, Pennsylvania, United States, 19140 |
Study Director: | 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) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04411628 |
Other Study ID Numbers: |
17823 J2W-MC-PYAA ( Other Identifier: Eli Lilly and Company ) |
First Posted: | June 2, 2020 Key Record Dates |
Last Update Posted: | October 30, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |