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

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Double blinded

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
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.
  • Drug: Placebo
    Placebo administered BID approximately 12 hours apart
Experimental
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.
  • Drug: Ruxolitinib
    Ruxolitinb administered BID approximately 12 hours apart
    Other names:
    • INCB018424
    • Oral Jak Inhibitor
Experimental
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.
  • Drug: Ruxolitinib
    Ruxolitinb administered BID approximately 12 hours apart
    Other names:
    • INCB018424
    • Oral Jak Inhibitor

More Details

Status
Terminated
Sponsor
Incyte Corporation

Study Contact