Study Stopped
Trial terminated for futility.
A Study of LY3127804 in Participants With COVID-19
A Randomized, Double-blind, Placebo-controlled, Clinical Trial of LY3127804 in Patients Who Are Hospitalized With Pneumonia and Presumed or Confirmed COVID-19
2 other identifiers
interventional
95
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started Apr 2020
Shorter than P25 for phase_2 covid19
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2020
CompletedFirst Posted
Study publicly available on registry
April 13, 2020
CompletedStudy Start
First participant enrolled
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2020
CompletedResults Posted
Study results publicly available
August 12, 2021
CompletedAugust 12, 2021
August 1, 2021
6 months
April 10, 2020
August 4, 2021
August 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 1 through Day 28
Secondary Outcomes (6)
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
Day 1 through Day 28
Percentage of Participants With Complete Response
Day 1 through Day 28
Number of Participants Who Died Between Day 1 Through Day 28
Day 1 through Day 28
Length of Hospitalization
Day 1 through Day 28
Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)
Day 1 through Day 60
- +1 more secondary outcomes
Study Arms (2)
LY3127804
EXPERIMENTALParticipants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15.
Placebo
PLACEBO COMPARATORParticipants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Banner Univ Med Ctr Phoenix
Phoenix, Arizona, 85006, United States
Banner Univ Med Ctr Tucson
Tucson, Arizona, 85719, United States
National Jewish Medical and Research Center
Denver, Colorado, 80206, United States
Nuvance Danbury Hospital
Danbury, Connecticut, 06810, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
Franciscan St. Francis Health
Indianapolis, Indiana, 46237, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Henry Ford Hospital Detroit
Detroit, Michigan, 48202-2689, United States
Allina Hospital Network
Minneapolis, Minnesota, 55404, United States
State University of New York Hospital
Syracuse, New York, 13210, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Related Publications (1)
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.
PMID: 35991210DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated for futility reason.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2020
First Posted
April 13, 2020
Study Start
April 20, 2020
Primary Completion
October 12, 2020
Study Completion
October 12, 2020
Last Updated
August 12, 2021
Results First Posted
August 12, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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
- 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
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