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
Results First Posted : August 12, 2021
Last Update Posted : August 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Pneumonia||Drug: LY3127804 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15.
Placebo Comparator: Placebo
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
- 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.
- 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.
- 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.
- Number of Participants Who Died Between Day 1 Through Day 28 [ Time Frame: Day 1 through Day 28 ]
- Length of Hospitalization [ Time Frame: Day 1 through Day 28 ]Days of participants hospitalization.
- 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.
- 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.
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
|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|
|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|