Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Cytokine storm, COVID-19, ARDS, SARS-CoV-2, ruxolitinib, pneumonia
Eligibility Criteria
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.
Sites / Locations
- Honor Health Research Institute
- Sharp Memorial Hospital
- Georgetown University Hospital
- Teradan Clinical Trials
- University of Florida
- Tampa General Hospital
- University of South Florida
- Northshore University Health System
- Loyola University Medical Center
- Indiana University Simon Cancer Center
- Indiana University Health Central Indiana Cancer Centers
- East Jefferson General Hospital
- Johns Hopkins University
- Boston Medical Center
- Lahey Hospital & Medical Center
- University of Massachusetts Medical School
- Healthpartners Cancer Care Center - Regions Hospital
- Mercy Research
- Hackensack University Medical Center
- Rutgers Njms Clinical Research Unit
- Holy Name Medical Center
- University of Rochester Medical Center
- Duke University Medical Center
- East Carolina University
- University of Cincinnati
- Kettering Cancer Care
- Jefferson University Hospitals
- Temple University
- West Penn Hospital
- Allegheny Health Network
- St David'S Medical Center
- University of Texas Health Science Center At Houston - McGovern Medical School
- University of Texas Health Science Cente
- Wenatchee Valley Hospital and Clinics
- Aurora Research Institute
- Sbih City Hospital 15
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebo + Standard of Care (SoC)
Ruxolitinib 5mg + Standard of Care (SoC)
Ruxolitininb 15mg + Standard of Care (SoC)
Matching Placebo will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 15mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.