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

• Status: Terminated
• Trial end date: 2021-02-26
• Target enrollment: 0
• Participant gender: All

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 mechanical ventilation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Janus Kinase Inhibitors

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.