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

Incyte

Status and phase: Terminated; Phase 3

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: Ruxolitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04377620

INCB 18424-369

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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211 participants in 3 patient groups, including a placebo group

Placebo + Standard of Care (SoC)

Placebo Comparator group

Description:

Matching Placebo will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.

Treatment:

Drug: Placebo

Ruxolitinib 5mg + Standard of Care (SoC)

Experimental group

Description:

Ruxolitinib 5mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.

Treatment:

Drug: Ruxolitinib

Ruxolitininb 15mg + Standard of Care (SoC)

Experimental group

Description:

Ruxolitinib 15mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.

Treatment:

Drug: Ruxolitinib