Status:
TERMINATED
A Study of LY3127804 in Participants With COVID-19
Lead Sponsor:
Eli Lilly and Company
Conditions:
COVID-19
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2020
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04342897
Start Date
April 20 2020
End Date
October 12 2020
Last Update
August 12 2021
Active Locations (13)
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1
Banner Univ Med Ctr Phoenix
Phoenix, Arizona, United States, 85006
2
Banner Univ Med Ctr Tucson
Tucson, Arizona, United States, 85719
3
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
4
Nuvance Danbury Hospital
Danbury, Connecticut, United States, 06810