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)
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.
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.
- IRB Number: 2004524816
- Research Study Identifier: TX11160
- Principal Investigator: Chadi Hage, MD
Recruitment StatusEnrolling By Invitation
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