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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04411628
Recruitment Status : Completed
First Posted : June 2, 2020
Results First Posted : November 9, 2021
Last Update Posted : November 12, 2021
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)
Actual Enrollment : 26 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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3819253
Participants received single doses of 700 milligrams (mg), 2800 mg or 7000 mg LY3819253 administered as intravenous infusion.
 Drug: LY3819253
Administered IV.
Other Names:
  • LY-CoV555
  • Bamlanivimab
Placebo Comparator: Placebo
Participants received single dose of Placebo as intravenous infusion.
 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 ]
    An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29 [ Time Frame: Day 29 ]
    Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29.

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

  3. Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC [ Time Frame: Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose ]
    The SARS-CoV-2 viral load was derived from the cycle time (CT) values using a polymerase chain reaction (PCR) assay. Higher CT values indicate a lower viral load.

  4. Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance [ Time Frame: Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose ]
    Pharmacodynamics (PD): Time to SARS-CoV-2 clearance.


Eligibility Criteria
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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


Locations
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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
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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] June 9, 2020
Statistical Analysis Plan  [PDF] June 4, 2020

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Results First Posted: November 9, 2021
Last Update Posted: November 12, 2021
Last Verified: November 2021
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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Bamlanivimab
Antiviral Agents
Anti-Infective Agents