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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
Last Update Posted : October 30, 2020
Sponsor:
Collaborator:
AbCellera Biologics Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 29, 2020
First Posted Date  ICMJE June 2, 2020
Last Update Posted Date October 30, 2020
Actual Study Start Date  ICMJE May 28, 2020
Actual Primary Completion Date August 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: LY3819253
    Administered IV.
    Other Names:
    • LY-CoV555
    • Bamlanivimab
  • Drug: Placebo
    Administered IV.
Study Arms  ICMJE
  • Experimental: LY3819253
    LY3819253 administered intravenously (IV).
    Intervention: Drug: LY3819253
  • Placebo Comparator: Placebo
    Placebo administered IV.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2020)
24
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2020)
40
Actual Study Completion Date  ICMJE August 26, 2020
Actual Primary Completion Date August 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04411628
Other Study ID Numbers  ICMJE 17823
J2W-MC-PYAA ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE AbCellera Biologics Inc.
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP