A Study of LY3127804 in Participants With COVID-19

A Randomized, Double-blind, Placebo-controlled, Clinical Trial of LY3127804 in Patients Who Are Hospitalized With Pneumonia and Presumed or Confirmed COVID-19

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

Study Overview

• Status: Terminated
• Conditions: COVID-19; Pneumonia
• Intervention / Treatment: Drug: Placebo; Drug: LY3127804

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Univ Med Ctr Phoenix
    • Tucson, Arizona, United States, 85719
      • Banner Univ Med Ctr Tucson
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Medical and Research Center
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Nuvance Danbury Hospital
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center
    • Indianapolis, Indiana, United States, 46237
      • Franciscan St. Francis Health
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202-2689
      • Henry Ford Hospital Detroit
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Allina Hospital Network
  • New York
    • Syracuse, New York, United States, 13210
      • State University of New York Hospital
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator Free Days	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.	Day 1 through Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale	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.	Day 1 through Day 28
Percentage of Participants With Complete Response	Complete response was defined as being alive and never requiring mechanical ventilator support (at any point while on study) through Day 28.	Day 1 through Day 28
Number of Participants Who Died Between Day 1 Through Day 28		Day 1 through Day 28
Length of Hospitalization	Days of participants hospitalization.	Day 1 through Day 28
Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)	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.	Day 1 through Day 60
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)	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.	Day 1 through Day 60

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• Jones RS, Smith PS, Berg PH, de la Pena A, Cook PP, Shawa I, Kioussopoulos KM, Hu Y, Schott RJ. Efficacy and Safety of LY3127804, an Anti-Angiopoietin-2 Antibody, in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Patients Hospitalized with Pneumonia and Presumed or Confirmed COVID-19. Clin Med Insights Circ Respir Pulm Med. 2022 Aug 10;16:11795484221119316. doi: 10.1177/11795484221119316. eCollection 2022. Erratum In: Clin Med Insights Circ Respir Pulm Med. 2022 Dec 13;16:11795484221127555.

Helpful Links

• A Study of LY3127804 in Participants With COVID-19

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2020
• Primary Completion (ACTUAL): October 12, 2020
• Study Completion (ACTUAL): October 12, 2020

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (ACTUAL): April 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Pulmonary Disease; Severe Acute Respiratory Syndrome (SARS); Corona Virus Disease 19 (COVID-19); 2019 Novel Coronavirus (2019 n-COV)
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia; Anti-Infective Agents; Antiviral Agents; Zansecimab
• Other Study ID Numbers: 17824; I7W-MC-UDAA (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
• IPD Sharing Access Criteria: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No