A Study of LY3127804 in Participants With COVID-19

NCT ID: NCT04342897

Last Updated: 2021-08-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2020-10-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LY3127804

Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15.

Group Type EXPERIMENTAL

LY3127804

Intervention Type DRUG

Administered IV

Placebo

Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY3127804

Administered IV

Intervention Type DRUG

Placebo

Administered IV

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Banner Univ Med Ctr Phoenix

Phoenix, Arizona, United States

Site Status

Banner Univ Med Ctr Tucson

Tucson, Arizona, United States

Site Status

National Jewish Medical and Research Center

Denver, Colorado, United States

Site Status

Nuvance Danbury Hospital

Danbury, Connecticut, United States

Site Status

NorthShore University HealthSystem

Evanston, Illinois, United States

Site Status

Parkview Research Center

Fort Wayne, Indiana, United States

Site Status

Franciscan St. Francis Health

Indianapolis, Indiana, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Site Status

Henry Ford Hospital Detroit

Detroit, Michigan, United States

Site Status

Allina Hospital Network

Minneapolis, Minnesota, United States

Site Status

State University of New York Hospital

Syracuse, New York, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Jones RS, Smith PS, Berg PH, de la Pena A, Cook PP, Shawa I, Kioussopoulos KM, Hu Y, Schott RJ. Efficacy and Safety of LY3127804, an Anti-Angiopoietin-2 Antibody, in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Patients Hospitalized with Pneumonia and Presumed or Confirmed COVID-19. Clin Med Insights Circ Respir Pulm Med. 2022 Aug 10;16:11795484221119316. doi: 10.1177/11795484221119316. eCollection 2022.

Reference Type DERIVED
PMID: 35991210 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

I7W-MC-UDAA

Identifier Type: OTHER

Identifier Source: secondary_id

17824

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Piclidenoson for Treatment of COVID-19
NCT04333472 COMPLETED PHASE2
COVID-19 and Anti-CD14 Treatment Trial
NCT04391309 TERMINATED PHASE2