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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY3127804 		Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15.
  • Drug: LY3127804
    Administered IV
Placebo Comparator
Placebo 		Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
  • Drug: Placebo
    Administered IV

Recruiting Locations

More Details

NCT ID
NCT04342897
Status
Terminated
Sponsor
Eli Lilly and Company

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.