A Study of LY3127804 in Participants With COVID-19

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04342897
• Other study ID #: 17824
• Secondary ID: I7W-MC-UDAA
• Status: Terminated
• Phase: Phase 2
• Start date: April 20, 2020
• Est. completion date: October 12, 2020

Study information

• Verified date: August 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 95
• Est. completion date: October 12, 2020
• Est. primary completion date: October 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

Drug:
• LY3127804
Administered IV
• Placebo
Administered IV

Locations

Country	Name	City	State
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	Nuvance Danbury Hospital	Danbury	Connecticut
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	Henry Ford Hospital Detroit	Detroit	Michigan
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Parkview Research Center	Fort Wayne	Indiana
United States	East Carolina University	Greenville	North Carolina
United States	Franciscan St. Francis Health	Indianapolis	Indiana
United States	Allina Hospital Network	Minneapolis	Minnesota
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Banner Univ Med Ctr Phoenix	Phoenix	Arizona
United States	State University of New York Hospital	Syracuse	New York
United States	Banner Univ Med Ctr Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of Participants Who Died Between Day 1 Through Day 28		Day 1 through Day 28
Secondary	Length of Hospitalization	Days of participants hospitalization.	Day 1 through Day 28
Secondary	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
Secondary	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

External Links

•   A Study of LY3127804 in Participants With COVID-19