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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Page 1 of 4 (13 locations)

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