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)

Incyte Corporation36 sites in 2 countries211 target enrollmentMay 24, 2020

ConditionsCOVID-19

InterventionsPlacebo Ruxolitinib

DrugsPlacebo Ruxolitinib

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: COVID-19
Sponsor: Incyte Corporation
Enrollment: 211
Locations: 36
Primary Endpoint: Percentage of Participants Who Have Died Due to Any Cause
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 24, 2020

End Date

February 26, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Incyte Corporation

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

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.

Intervention: Placebo

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.

Intervention: Ruxolitinib

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.

Intervention: Ruxolitinib

Outcomes

Primary Outcomes

Percentage of Participants Who Have Died Due to Any Cause

Time Frame: Study start to Day 29

To evaluate the 28-day mortality rate of ruxolitinib 5 mg BID + SoC therapy and ruxolitinib 15 mg BID + SoC compared with placebo + SoC therapy, in participants with COVID-19-associated ARDS who require mechanical ventilation.

Secondary Outcomes

Number of Ventilator Free Days(Study start to Day 29)
Oxygen Free Days(Study start to Day 29)
Vasopressor Free Days(Study start to Day 29)
Hospital Free Days(Study start to Day 29)
Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale(Study start to Days 15 and 29)
Number of ICU Free Days(Study start to Day 29)
Percentage of Participants With the COVID-19 Ordinal Scale Reported(Study start to Day 29)
Change in SOFA Score(from baseline to Days 3, 5, 8, 11, 15, and 29)
Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale(Study start to Days 15 and 29)
Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events(Study start to Day 29)
Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale(Study Start to Day 29)
Change in the COVID-19 9-point Ordinal Scale(Study start to Days 15 and 29)