A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Ruxolitinib in Participants With COVID-19–Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
Chadi Hage, MD
Primary Investigator
Overview
There are no approved treatments for COVID-19–associated ARDS. The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19–associated ARDS who require mechanical ventilation.
Although there are no approved treatments for COVID-19, SoC therapy for participants with COVID-19 pneumonia generally includes supportive care, antiviral treatments, and when required, mechanical ventilation. Thus, placebo + SoC therapy is appropriate as a control in this study.
Description
Eligible participants will be randomized after completing the screening period (Day −1) and having been confirmed eligible. Screening and randomization may occur on the same day.
Study period of 29 days. Treatment with ruxolitinib 5 mg BID/placebo or ruxolitinib 15 mg BID/placebo will initially be administered for 14 days. If in the opinion of the treating investigator the benefit/risk is appropriate for the participant, then continued treatment up to 28 days is permitted with approval from the sponsor medical monitor.
The safety follow-up 28 days after last dose of study treatment will assess the long-term safety and tolerability profile after completion of ruxolitinib/placebo dosing.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
COVID, COVID19, COVID-19, ARDS, ventilation
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Age: Between 18 Years - 100 Years
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Gender: All
Eligibility Criteria:
• Participant or health proxy must provide informed consent before any study assessment is performed.
• Male or female participants aged ≥ 18 years.
• Participants with coronavirus (SARS-CoV-2) infection confirmed ≤ 2 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.