A Study of LY3127804 in Participants With COVID-19

Lilly

Status and phase: Terminated; Phase 2

Conditions: COVID-19; Pneumonia

Treatments: Drug: LY3127804; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04342897

17824

I7W-MC-UDAA (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 2 patient groups, including a placebo group

LY3127804

Experimental group

Description:

Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15.

Treatment:

Drug: LY3127804

Placebo

Placebo Comparator group

Description:

Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.

Treatment:

Drug: Placebo