Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
95 participants
INTERVENTIONAL
2020-04-20
2020-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY3127804
Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15.
LY3127804
Administered IV
Placebo
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
Placebo
Administered IV
Interventions
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LY3127804
Administered IV
Placebo
Administered IV
Eligibility Criteria
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Inclusion Criteria
* Are able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Banner Univ Med Ctr Phoenix
Phoenix, Arizona, United States
Banner Univ Med Ctr Tucson
Tucson, Arizona, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
Nuvance Danbury Hospital
Danbury, Connecticut, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Franciscan St. Francis Health
Indianapolis, Indiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Henry Ford Hospital Detroit
Detroit, Michigan, United States
Allina Hospital Network
Minneapolis, Minnesota, United States
State University of New York Hospital
Syracuse, New York, United States
East Carolina University
Greenville, North Carolina, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3127804 in Participants With COVID-19
Other Identifiers
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I7W-MC-UDAA
Identifier Type: OTHER
Identifier Source: secondary_id
17824
Identifier Type: -
Identifier Source: org_study_id
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