Status:
TERMINATED
Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
Lead Sponsor:
Incyte Corporation
Conditions:
COVID-19
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 mechani...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2021
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT04377620
Start Date
May 24 2020
End Date
February 26 2021
Last Update
January 19 2022
Active Locations (36)
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1
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258
2
Sharp Memorial Hospital
San Diego, California, United States, 92123
3
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
4
Teradan Clinical Trials
Brandon, Florida, United States, 33511