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A Study of LY3127804 in Participants With COVID-19

Primary Purpose

COVID-19, Pneumonia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LY3127804
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Corona Virus Disease 19 (COVID-19), 2019 Novel Coronavirus (2019 n-COV), Severe Acute Respiratory Syndrome (SARS), Pulmonary Disease, SARS-CoV-2

Eligibility Criteria

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

Inclusion Criteria:

  • Are hospitalized with pneumonia, and presumed or confirmed COVID-19
  • Are able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed)

Exclusion Criteria:

  • Female participants must not be pregnant and/or lactating
  • Have Acute Respiratory Distress Syndrome (ARDS) or will require immediate intermittent mandatory ventilation (IMV), or are ineligible for IMV
  • Have any concurrent serious medical condition (for example dialysis) or concomitant medication that would preclude participation in the study
  • Are moribund irrespective of the provision of treatments
  • Have a known history or show evidence of human immunodeficiency virus (HIV) and/or hepatitis
  • Have recently undergone major surgery or central venous access device placement
  • Have a significant bleeding disorder or active vasculitis
  • Have experienced a thromboembolic event
  • Have symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia
  • Have a serious, nonhealing wound, peptic ulcer, or bone fracture
  • Have liver cirrhosis
  • Have a known sensitivity to monoclonal antibodies (mAbs) or other therapeutic proteins
  • Have a history of hypertensive crisis or hypertensive encephalopathy or current, poorly controlled hypertension

Sites / Locations

  • Banner Univ Med Ctr Phoenix
  • Banner Univ Med Ctr Tucson
  • National Jewish Medical and Research Center
  • Nuvance Danbury Hospital
  • NorthShore University HealthSystem
  • Parkview Research Center
  • Franciscan St. Francis Health
  • Ochsner Clinic Foundation
  • Lahey Hospital and Medical Center
  • Henry Ford Hospital Detroit
  • Allina Hospital Network
  • State University of New York Hospital
  • East Carolina University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3127804

Placebo

Arm Description

Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15.

Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.

Outcomes

Primary Outcome Measures

Ventilator Free Days
Ventilator-free days were defined as the number of days from Day 1 through Day 28 on which a participant breathed without assistance, if the period of unassisted breathing lasted at least 24 consecutive hours and the participant did not die within 28 days from the first dose of the study drug.

Secondary Outcome Measures

Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
The NIAID ordinal scale clinical status was defined as the lowest score achieved for that day, the lowest NIAID score from Day 1 through Day 28 for each participant was reported. NIAID ordinal assessment levels are reported by using the following 8 point scale, where a higher score is a better outcome: 1) death, 2) hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO), 3) hospitalized, on non-invasive ventilation or high-flow oxygen devices, 4) hospitalized, requiring supplemental oxygen, 5) hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19-related or otherwise), 6) hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care, 7) not hospitalized, limitation on activities and/or requiring home oxygen, and, 8) not hospitalized, no limitations on activities.
Percentage of Participants With Complete Response
Complete response was defined as being alive and never requiring mechanical ventilator support (at any point while on study) through Day 28.
Number of Participants Who Died Between Day 1 Through Day 28
Length of Hospitalization
Days of participants hospitalization.
Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)
An SAE is any AE from this study that results in one of the following outcomes: death that is not related to COVID-19 or a sequela of COVID-19 or death that is considered by the investigator to be related to study drug, prolonged inpatient hospitalization or re-hospitalization life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other SAE outcomes.
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
TEAE was defined as any untoward medical occurrence that emerges during a defined treatment period, having been absent pre-treatment, or worsens relative to the pretreatment state, and does not necessarily had a causal relationship with the study treatment.

Full Information

First Posted
April 10, 2020
Last Updated
August 4, 2021
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04342897
Brief Title
A Study of LY3127804 in Participants With COVID-19
Official Title
A Randomized, Double-blind, Placebo-controlled, Clinical Trial of LY3127804 in Patients Who Are Hospitalized With Pneumonia and Presumed or Confirmed COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Trial terminated for futility.
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
October 12, 2020 (Actual)
Study Completion Date
October 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized, double-blind, placebo-controlled, clinical trial of LY3127804 in participants who are hospitalized with pneumonia and presumed or confirmed COVID-19.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Pneumonia
Keywords
Corona Virus Disease 19 (COVID-19), 2019 Novel Coronavirus (2019 n-COV), Severe Acute Respiratory Syndrome (SARS), Pulmonary Disease, SARS-CoV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3127804
Arm Type
Experimental
Arm Description
Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
Intervention Type
Drug
Intervention Name(s)
LY3127804
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Ventilator Free Days
Description
Ventilator-free days were defined as the number of days from Day 1 through Day 28 on which a participant breathed without assistance, if the period of unassisted breathing lasted at least 24 consecutive hours and the participant did not die within 28 days from the first dose of the study drug.
Time Frame
Day 1 through Day 28
Secondary Outcome Measure Information:
Title
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
Description
The NIAID ordinal scale clinical status was defined as the lowest score achieved for that day, the lowest NIAID score from Day 1 through Day 28 for each participant was reported. NIAID ordinal assessment levels are reported by using the following 8 point scale, where a higher score is a better outcome: 1) death, 2) hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO), 3) hospitalized, on non-invasive ventilation or high-flow oxygen devices, 4) hospitalized, requiring supplemental oxygen, 5) hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19-related or otherwise), 6) hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care, 7) not hospitalized, limitation on activities and/or requiring home oxygen, and, 8) not hospitalized, no limitations on activities.
Time Frame
Day 1 through Day 28
Title
Percentage of Participants With Complete Response
Description
Complete response was defined as being alive and never requiring mechanical ventilator support (at any point while on study) through Day 28.
Time Frame
Day 1 through Day 28
Title
Number of Participants Who Died Between Day 1 Through Day 28
Time Frame
Day 1 through Day 28
Title
Length of Hospitalization
Description
Days of participants hospitalization.
Time Frame
Day 1 through Day 28
Title
Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)
Description
An SAE is any AE from this study that results in one of the following outcomes: death that is not related to COVID-19 or a sequela of COVID-19 or death that is considered by the investigator to be related to study drug, prolonged inpatient hospitalization or re-hospitalization life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other SAE outcomes.
Time Frame
Day 1 through Day 60
Title
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
Description
TEAE was defined as any untoward medical occurrence that emerges during a defined treatment period, having been absent pre-treatment, or worsens relative to the pretreatment state, and does not necessarily had a causal relationship with the study treatment.
Time Frame
Day 1 through Day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are hospitalized with pneumonia, and presumed or confirmed COVID-19 Are able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed) Exclusion Criteria: Female participants must not be pregnant and/or lactating Have Acute Respiratory Distress Syndrome (ARDS) or will require immediate intermittent mandatory ventilation (IMV), or are ineligible for IMV Have any concurrent serious medical condition (for example dialysis) or concomitant medication that would preclude participation in the study Are moribund irrespective of the provision of treatments Have a known history or show evidence of human immunodeficiency virus (HIV) and/or hepatitis Have recently undergone major surgery or central venous access device placement Have a significant bleeding disorder or active vasculitis Have experienced a thromboembolic event Have symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia Have a serious, nonhealing wound, peptic ulcer, or bone fracture Have liver cirrhosis Have a known sensitivity to monoclonal antibodies (mAbs) or other therapeutic proteins Have a history of hypertensive crisis or hypertensive encephalopathy or current, poorly controlled hypertension
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
Banner Univ Med Ctr Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Banner Univ Med Ctr Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Nuvance Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Franciscan St. Francis Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Henry Ford Hospital Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
Facility Name
Allina Hospital Network
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
State University of New York Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
IPD Sharing Access Criteria
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting
IPD Sharing URL
http://vivli.org/
Citations:
PubMed Identifier
35991210
Citation
Jones RS, Smith PS, Berg PH, de la Pena A, Cook PP, Shawa I, Kioussopoulos KM, Hu Y, Schott RJ. Efficacy and Safety of LY3127804, an Anti-Angiopoietin-2 Antibody, in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Patients Hospitalized with Pneumonia and Presumed or Confirmed COVID-19. Clin Med Insights Circ Respir Pulm Med. 2022 Aug 10;16:11795484221119316. doi: 10.1177/11795484221119316. eCollection 2022. Erratum In: Clin Med Insights Circ Respir Pulm Med. 2022 Dec 13;16:11795484221127555.
Results Reference
derived
Links:
URL
https://www.lillytrialguide.com/en-US/studies/covid-19--coronavirus-/UDAA#?postal=
Description
A Study of LY3127804 in Participants With COVID-19

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A Study of LY3127804 in Participants With COVID-19

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