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Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT) | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)

NCT04377620•Incyte Corporation

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant or guardian health proxy must provide informed consent before any study assessment is performed.
•Male or female participants aged ≥ 12 years.
•Participants with coronavirus (SARS-CoV-2) infection confirmed ≤ 3 weeks prior to randomization by any test with local regulatory approval.
•Participants who are intubated and receiving mechanical ventilation due to COVID-19-associated ARDS and have a PaO2/FiO2 of ≤ 300 mmHg within 6 -hours of randomization.
•Participants with lung imaging showing bilateral or diffuse pulmonary infiltrates on chest x-ray or CT scan.

Exclusion Criteria

•Known history of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
•Presence of severely impaired renal function defined by estimated creatinine clearance \< 15 mL/min measured or calculated by Cockcroft-Gault equation or calculated by the updated bedside Schwartz equation. Participants must not be receiving CRRT or intermittent hemodialysis at screening.
•In the opinion of the investigator, unlikely to survive for \> 24 hours from randomization.
•Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
•Currently receiving ECMO.
•Participant may not be sharing a ventilator, or co-ventilating, with any other patient.
•Treatment with anti-IL-6, IL-6R, IL-1RA, IL-1β, or GM-CSF antagonists, or a BTK inhibitor, within 7 days of randomization.
•Treatment with a JAK inhibitor within 30 days of randomization.
•Participants who are on long-term use of antirejection or immunomodulatory drugs.
•Pregnant or nursing (lactating) women.

Locations (36)

Honor Health Research Institute

Scottsdale, Arizona, United States

Sharp Memorial Hospital

San Diego, California, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Teradan Clinical Trials

Brandon, Florida, United States

University of Florida

Gainesville, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

University of South Florida

Tampa, Florida, United States

Northshore University Health System

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Key Dates

Start Date

May 24, 2020

Primary Completion Date

February 26, 2021

Completion Date

February 26, 2021

Last Updated

January 19, 2022

Enrollment

211

ACTUAL participants

Conditions

COVID-19

Interventions

Placebo

DRUG

Ruxolitinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)

Inclusion Criteria

Exclusion Criteria

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