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

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ClinicalTrials.gov Identifier: NCT04377620
Recruitment Status : Terminated (Study terminated by sponsor)
First Posted : May 6, 2020
Results First Posted : January 19, 2022
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE May 4, 2020
First Posted Date  ICMJE May 6, 2020
Results First Submitted Date  ICMJE November 17, 2021
Results First Posted Date  ICMJE January 19, 2022
Last Update Posted Date January 19, 2022
Actual Study Start Date  ICMJE May 24, 2020
Actual Primary Completion Date February 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
Proportion of participants who have died due to any cause [ Time Frame: Up 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2021)
  • Number of Ventilator Free Days [ Time Frame: Study start to Day 29 ]
    Number of days participant did not require mechanical ventilation
  • Number of ICU Free Days [ Time Frame: Study start to Day 29 ]
    Number of days participant is out of the ICU
  • Oxygen Free Days [ Time Frame: Study start to Day 29 ]
    Number of days participant did not receive supplemental oxygen
  • Vasopressor Free Days [ Time Frame: Study start to Day 29 ]
    Number of days without use of vasopressor therapy
  • Hospital Free Days [ Time Frame: Study start to Day 29 ]
    Number of days Partcipant is out of the hospital
  • Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale [ Time Frame: Study start to Days 15 and 29 ]
    Participants with at least 2-point improvement at Day 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
  • Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale [ Time Frame: Study start to Days 15 and 29 ]
    Participants with at lest 1-point improvement in clinical status at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
  • Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale [ Time Frame: Study Start to Day 29 ]
    TIme to improvement compared to baseline. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
  • Percentage of Participants With the COVID-19 Ordinal Scale Reported [ Time Frame: Study start to Day 29 ]
    Clinical status of participant at Day 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
  • Change in the COVID-19 9-point Ordinal Scale [ Time Frame: Study start to Days 15 and 29 ]
    Change in the Clinical status of participant at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
  • Change in SOFA Score [ Time Frame: from baseline to Days 3, 5, 8, 11, 15, and 29 ]
    Sequential Organ Failure Assessment (SOFA) score is a scoring system to determine the extent of a person's organ function or rate of failure. The score is based on 6 different scores, 1 each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).
  • Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events [ Time Frame: Study start to Day 29 ]
    Treatment-emergent AEs are judged as related by the investigator or have a missing causality.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Number of Ventilator free days [ Time Frame: Day 29 ]
    Number of days participant did not require mechanical ventilation
  • Number of ICU free days [ Time Frame: Day 29 ]
    Number of days participant is out of the ICU
  • Oxygen free days [ Time Frame: Day 29 ]
    Number of days participant did not receive supplemental oxygen
  • Vasopressor free days [ Time Frame: Day 29 ]
    Number of days without use of vasopressor therapy
  • Hospital free days [ Time Frame: Day 29 ]
    Number of days Partcipant is out of the hospital
  • Improvement in the COVID-19 ordinal scale [ Time Frame: Day 15 and 29 ]
    Clinical status of participant at Day 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
  • Change in SOFA Score [ Time Frame: from baseline to Days 3, 5, 8, 11, 15, and 29 ]
    SOFA score is a scoring system to determine the extent of a person's organ function or rate of failure. The score is based on 6 different scores, 1 each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems.
  • Number of treatment-related adverse events [ Time Frame: Day 29 ]
    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double blinded
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Placebo
    Placebo administered BID approximately 12 hours apart
  • Drug: Ruxolitinib
    Ruxolitinb administered BID approximately 12 hours apart
    Other Names:
    • INCB018424
    • Oral Jak Inhibitor
Study Arms  ICMJE
  • Placebo Comparator: 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: Drug: Placebo
  • Experimental: 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: Drug: Ruxolitinib
  • Experimental: 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: Drug: Ruxolitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 11, 2021)
211
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2020)
500
Actual Study Completion Date  ICMJE February 26, 2021
Actual Primary Completion Date February 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04377620
Other Study ID Numbers  ICMJE INCB 18424-369
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Incyte Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Incyte Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Incyte Corporation
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP