A randomized, double-blind, placebo-controlled, clinical trial of LY3127804 in participants who are hospitalized with pneumonia and presumed or confirmed COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
95
Banner Univ Med Ctr Phoenix
Phoenix, Arizona, United States
Banner Univ Med Ctr Tucson
Tucson, Arizona, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
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.
Time frame: Day 1 through Day 28
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.
Time frame: 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.
Time frame: Day 1 through Day 28
Number of Participants Who Died Between Day 1 Through Day 28
Time frame: Day 1 through Day 28
Length of Hospitalization
Days of participants hospitalization.
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Nuvance Danbury Hospital
Danbury, Connecticut, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Franciscan St. Francis Health
Indianapolis, Indiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Henry Ford Hospital Detroit
Detroit, Michigan, United States
...and 3 more locations
Time frame: 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.
Time frame: 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.
Time frame: Day 1 through Day 60