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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04377620

Run by

Incyte Corporation

People needed

211

Starts

2020-05-24

Expected to finish

2021-02-26

Last updated by the study team

2022-01-19

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Indiana University Health Central Indiana Cancer Centers — Indianapolis, Indiana, United States
• East Jefferson General Hospital — Metairie, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Lahey Hospital & Medical Center — Burlington, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Healthpartners Cancer Care Center - Regions Hospital — Saint Paul, Minnesota, United States
• Mercy Research — Springfield, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Rutgers Njms Clinical Research Unit — Newark, New Jersey, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.