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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04411628
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
AbCellera Biologics Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: LY3819253 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : August 23, 2020
Estimated Study Completion Date : August 23, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3819253
LY3819253 administered intravenously (IV).
 Drug: LY3819253
Administered IV.
Other Name: LY-CoV555
Placebo Comparator: Placebo
Placebo administered IV.
 Drug: Placebo
Administered IV.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration-time Curve (AUC) of LY3819253 [ Time Frame: Baseline through Day 29 ]
    PK: AUC of LY3819253

  2. Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load [ Time Frame: Baseline, Day 29 ]
    PD: Change from Baseline in Viral Load


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact    424-315-2861      
Principal Investigator: Peter Chen         
Veterans Affairs Medical Center San Diego Not yet recruiting
San Diego, California, United States, 92161
Contact    480-256-6444      
Principal Investigator: Mary K Lewinski         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact    404-712-1435      
Principal Investigator: Nadine G Rouphael         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact    617-726-6609      
Principal Investigator: Michael L Dougan         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact    734-936-3662      
Principal Investigator: Pauline K Park         
United States, Nebraska
Quality Clinical Research, Inc. Not yet recruiting
Omaha, Nebraska, United States, 68114
Principal Investigator: Rudolph J Kotula         
United States, New York
Alexandria Center for Life - NYC/ NYCEDC Recruiting
New York, New York, United States, 10016
Contact    646-501-0681      
Principal Investigator: Mark J Mulligan         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact    410-908-7779      
Principal Investigator: William A Fischer         
United States, Pennsylvania
Temple University School of Medicine Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Principal Investigator: GERARD J CRINER         
Sponsors and Collaborators
Eli Lilly and Company
AbCellera Biologics Inc.
Investigators
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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
More Information
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Additional Information:

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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: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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