Clinical trial NCT04342897: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-04-13
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Ventilator Free Days
timeFrame: Day 1 through Day 28
Secondary outcomes:
measure: Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
timeFrame: Day 1 through Day 28
measure: Percentage of Participants With Complete Response
timeFrame: Day 1 through Day 28
measure: Number of Participants Who Died Between Day 1 Through Day 28
timeFrame: Day 1 through Day 28
measure: Length of Hospitalization
timeFrame: Day 1 through Day 28
measure: Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)
timeFrame: Day 1 through Day 60
measure: Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
timeFrame: Day 1 through Day 60
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Univ Med Ctr Phoenix
state: Arizona
city: Tucson
country: United States
facility: Banner Univ Med Ctr Tucson
state: Arizona
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Danbury
country: United States
facility: Nuvance Danbury Hospital
state: Connecticut
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital Detroit
state: Michigan
city: Minneapolis
country: United States
facility: Allina Hospital Network
state: Minnesota
city: Syracuse
country: United States
facility: State University of New York Hospital
state: New York
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
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.