A Study of LY3127804 in Participants With COVID-19

Phase 2

Terminated

• Conditions: Pneumonia; COVID-19
• Interventions: Drug: Placebo; Drug: LY3127804

• Registration Number: NCT04342897
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-13
• Study Start: 2020-04-20
• Primary Completion: 2020-10-12
• Study Completion: 2020-10-12
• Status Verified: 2021-08
• Results First Submitted: 2021-08-04
• Results First Submitted QC: 2021-08-04
• Last Update Submitted: 2021-08-04
• Results First Posted: 2021-08-12
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 95

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Ventilator Free Days	Day 1 through Day 28	Ventilator-free days were defined as the number of days from Day 1 through Day 28 on which a participant breathed without assistance, if the period of unassisted breathing lasted at least 24 consecutive hours and the participant did not die within 28 days from the first dose of the study drug.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale	Day 1 through Day 28	The NIAID ordinal scale clinical status was defined as the lowest score achieved for that day, the lowest NIAID score from Day 1 through Day 28 for each participant was reported. NIAID ordinal assessment levels are reported by using the following 8 point scale, where a higher score is a better outcome: 1) death, 2) hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO), 3) hospitalized, on non-invasive ventilation or high-flow oxygen devices, 4) hospitalized, requiring supplemental oxygen, 5) hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19-related or otherwise), 6) hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care, 7) not hospitalized, limitation on activities and/or requiring home oxygen, and, 8) not hospitalized, no limitations on activities.
Percentage of Participants With Complete Response	Day 1 through Day 28	Complete response was defined as being alive and never requiring mechanical ventilator support (at any point while on study) through Day 28.
Number of Participants Who Died Between Day 1 Through Day 28	Day 1 through Day 28
Length of Hospitalization	Day 1 through Day 28	Days of participants hospitalization.
Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)	Day 1 through Day 60	An SAE is any AE from this study that results in one of the following outcomes: death that is not related to COVID-19 or a sequela of COVID-19 or death that is considered by the investigator to be related to study drug, prolonged inpatient hospitalization or re-hospitalization life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other SAE outcomes.
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)	Day 1 through Day 60	TEAE was defined as any untoward medical occurrence that emerges during a defined treatment period, having been absent pre-treatment, or worsens relative to the pretreatment state, and does not necessarily had a causal relationship with the study treatment.

Trial Locations

Locations (13)

Banner Univ Med Ctr Tucson; 🇺🇸 Tucson, Arizona, United States

Nuvance Danbury Hospital; 🇺🇸 Danbury, Connecticut, United States

Franciscan St. Francis Health; 🇺🇸 Indianapolis, Indiana, United States

Lahey Hospital and Medical Center; 🇺🇸 Burlington, Massachusetts, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Henry Ford Hospital Detroit; 🇺🇸 Detroit, Michigan, United States

National Jewish Medical and Research Center; 🇺🇸 Denver, Colorado, United States

Allina Hospital Network; 🇺🇸 Minneapolis, Minnesota, United States

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States

State University of New York Hospital; 🇺🇸 Syracuse, New York, United States

Banner Univ Med Ctr Phoenix; 🇺🇸 Phoenix, Arizona, United States

Parkview Research Center; 🇺🇸 Fort Wayne, Indiana, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States