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A Study of LY3127804 in Participants With COVID-19

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ClinicalTrials.gov Identifier: NCT04342897
Recruitment Status : Terminated (Trial terminated for futility.)
First Posted : April 13, 2020
Results First Posted : August 12, 2021
Last Update Posted : August 12, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: LY3127804 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Clinical Trial of LY3127804 in Patients Who Are Hospitalized With Pneumonia and Presumed or Confirmed COVID-19
Actual Study Start Date : April 20, 2020
Actual Primary Completion Date : October 12, 2020
Actual Study Completion Date : October 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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




Primary Outcome Measures :
  1. Ventilator Free Days [ Time Frame: 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 :
  1. Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale [ Time Frame: 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.

  2. Percentage of Participants With Complete Response [ Time Frame: 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.

  3. Number of Participants Who Died Between Day 1 Through Day 28 [ Time Frame: Day 1 through Day 28 ]
  4. Length of Hospitalization [ Time Frame: Day 1 through Day 28 ]
    Days of participants hospitalization.

  5. Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE) [ Time Frame: 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.

  6. Number of Participants With Any Treatment Emergent Adverse Event (TEAE) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342897


Locations
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United States, Arizona
Banner Univ Med Ctr Phoenix
Phoenix, Arizona, United States, 85006
Banner Univ Med Ctr Tucson
Tucson, Arizona, United States, 85719
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Connecticut
Nuvance Danbury Hospital
Danbury, Connecticut, United States, 06810
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
United States, Indiana
Parkview Research Center
Fort Wayne, Indiana, United States, 46845
Franciscan St. Francis Health
Indianapolis, Indiana, United States, 46237
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
United States, Michigan
Henry Ford Hospital Detroit
Detroit, Michigan, United States, 48202-2689
United States, Minnesota
Allina Hospital Network
Minneapolis, Minnesota, United States, 55404
United States, New York
State University of New York Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] June 11, 2020
Statistical Analysis Plan  [PDF] February 9, 2021

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04342897    
Other Study ID Numbers: 17824
I7W-MC-UDAA ( Other Identifier: Eli Lilly and Company )
First Posted: April 13, 2020    Key Record Dates
Results First Posted: August 12, 2021
Last Update Posted: August 12, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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
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
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Corona Virus Disease 19 (COVID-19)
2019 Novel Coronavirus (2019 n-COV)
Severe Acute Respiratory Syndrome (SARS)
Pulmonary Disease
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases