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
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. The study may last up to 9 weeks and include daily visits up to day 28, and follow-up visits by phone.

Active, not recruiting
COVID-19
Pneumonia

Drug: LY3127804
Administered IV
LY3127804

Drug: Placebo
Administered IV
Placebo

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Banner Univ Med Ctr Phoenix
Phoenix, Arizona, 85006

Banner Univ Med Ctr Tucson
Tucson, Arizona, 85719

National Jewish Medical and Research Center
Denver, Colorado, 80206

Nuvance Danbury Hospital
Danbury, Connecticut, 06810

NorthShore University HealthSystem
Evanston, Illinois, 60201

Parkview Research Center
Fort Wayne, Indiana, 46845

Franciscan St. Francis Health
Indianapolis, Indiana, 46237

Ochsner Clinic Foundation
New Orleans, Louisiana, 70121

Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805

Henry Ford Hospital Detroit
Detroit, Michigan, 48202-2689

Allina Hospital Network
Minneapolis, Minnesota, 55404

State University of New York Hospital
Syracuse, New York, 13210

East Carolina University
Greenville, North Carolina, 27834

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)
Study Director
Eli Lilly and Company

Eli Lilly and Company
NCT Number
Keywords
Corona Virus Disease 19 (COVID-19)
2019 Novel Coronavirus (2019 n-COV)
Severe Acute Respiratory Syndrome (SARS)
Pulmonary Disease
SARS-CoV-2
MeSH Terms
Pneumonia