A Study of LY3127804 in Participants With COVID-19

• Status: Terminated
• Trial end date: 2020-10-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

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