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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3819253
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for COVID-19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars Sinai Medical Center
  • Veterans Affairs Medical Center San Diego
  • Emory University
  • Massachusetts General Hospital
  • University of Massachusetts Medical Center
  • University of Michigan
  • Quality Clinical Research, Inc.
  • Alexandria Center for Life - NYC/ NYCEDC
  • University of North Carolina
  • Unified Research Enterprise Brody School of Medicine at ECU
  • Temple Univ School of Med

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3819253

Placebo

Arm Description

Participants received single doses of 700 milligrams (mg), 2800 mg or 7000 mg LY3819253 administered as intravenous infusion.

Participants received single dose of Placebo as intravenous infusion.

Outcomes

Primary Outcome Measures

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
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

Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29
Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29.
Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load
Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load.
Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC
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.
Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance
Pharmacodynamics (PD): Time to SARS-CoV-2 clearance.

Full Information

First Posted
May 29, 2020
Last Updated
November 10, 2021
Sponsor
Eli Lilly and Company
Collaborators
AbCellera Biologics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04411628
Brief Title
A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
August 26, 2020 (Actual)
Study Completion Date
August 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
AbCellera Biologics Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3819253
Arm Type
Experimental
Arm Description
Participants received single doses of 700 milligrams (mg), 2800 mg or 7000 mg LY3819253 administered as intravenous infusion.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received single dose of Placebo as intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
LY3819253
Other Intervention Name(s)
LY-CoV555, Bamlanivimab
Intervention Description
Administered IV.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered IV.
Primary Outcome Measure Information:
Title
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
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.
Time Frame
Baseline through Day 60
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29
Description
Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29.
Time Frame
Day 29
Title
Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load
Description
Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load.
Time Frame
Baseline, Day 29
Title
Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC
Description
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.
Time Frame
Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose
Title
Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance
Description
Pharmacodynamics (PD): Time to SARS-CoV-2 clearance.
Time Frame
Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Veterans Affairs Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Massachusetts Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Quality Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Alexandria Center for Life - NYC/ NYCEDC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Unified Research Enterprise Brody School of Medicine at ECU
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Temple Univ School of Med
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35713300
Citation
Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
Results Reference
derived
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived
PubMed Identifier
34374951
Citation
Nathan R, Shawa I, De La Torre I, Pustizzi JM, Haustrup N, Patel DR, Huhn G. A Narrative Review of the Clinical Practicalities of Bamlanivimab and Etesevimab Antibody Therapies for SARS-CoV-2. Infect Dis Ther. 2021 Dec;10(4):1933-1947. doi: 10.1007/s40121-021-00515-6. Epub 2021 Aug 10.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/3B9kHya2iCF9SHumC5PLKk
Description
A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19

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

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