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A Study of LY3127804 in Participants With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342897
Recruitment Status : Terminated (Trial terminated for futility.)
First Posted : April 13, 2020
Last Update Posted : October 29, 2020
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. The study may last up to 9 weeks and include daily visits up to day 28, and follow-up visits by phone.

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
LY3127804 administered intravenously (IV), with standard of care treatment
Drug: LY3127804
Administered IV

Placebo Comparator: Placebo
Placebo administered IV, with standard of care treatment
Drug: Placebo
Administered IV




Primary Outcome Measures :
  1. Number of Ventilator Free Days [ Time Frame: Day 1 to Day 28 ]
    Number of days on which a participant breathes without assistance


Secondary Outcome Measures :
  1. Number of Participants Reporting Each Severity Rating on the National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Assessment [ Time Frame: Day 1 to Day 28 ]
    The scale is an assessment of clinical status. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation 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; 8) Not hospitalized, no limitations on activities

  2. Percentage of Participants who are Alive and Respiratory Failure Free [ Time Frame: Day 1 to Day 28 ]
    Survival without Respiratory Failure

  3. Mortality [ Time Frame: Day 1 to Day 28 ]
    Mortality

  4. Length of Hospitalization [ Time Frame: Day 1 to Day 28 ]
    Days of Hospitalization

  5. Number of Participants with any Serious Adverse Event (SAE) [ Time Frame: Day 1 to Day 28 ]
    Number of Participants with any Serious Adverse Event (SAE)

  6. Number of Participants with any Treatment Emergent Adverse Event (TEAE) [ Time Frame: Day 1 to Day 28 ]
    Number of Participants with any Treatment Emergent Adverse Event (TEAE)



Information from the National Library of Medicine

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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
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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
Last Update Posted: October 29, 2020
Last Verified: October 2020
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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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections