Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
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.
- Eligible Ages
- Over 12 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Investigator)
- Masking Description
- Double blinded
Placebo + 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 + Standard of Care (SoC)
|Ruxolitinib 5mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.||
Ruxolitininb 15mg + Standard of Care (SoC)
|Ruxolitinib 15mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.||
- Incyte Corporation
Study ContactIncyte Corporation Call Center (US)