A randomized, double-blind, placebo-controlled, clinical trial of LY3127804 in participants who are hospitalized with pneumonia and presumed or confirmed COVID-19.
Drug: LY3127804
Administered IV
Drug: Placebo
Administered IV
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
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
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