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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Placebo Drug: Ruxolitinib Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blinded
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : May 24, 2020
Actual Primary Completion Date : February 26, 2021
Actual Study Completion Date : February 26, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Placebo
Placebo administered BID approximately 12 hours apart
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.
 Drug: Ruxolitinib
Ruxolitinb administered BID approximately 12 hours apart
Other Names:
  • INCB018424
  • Oral Jak Inhibitor
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.
 Drug: Ruxolitinib
Ruxolitinb administered BID approximately 12 hours apart
Other Names:
  • INCB018424
  • Oral Jak Inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of Ventilator Free Days [ Time Frame: Study start to Day 29 ]
    Number of days participant did not require mechanical ventilation

  2. Number of ICU Free Days [ Time Frame: Study start to Day 29 ]
    Number of days participant is out of the ICU

  3. Oxygen Free Days [ Time Frame: Study start to Day 29 ]
    Number of days participant did not receive supplemental oxygen

  4. Vasopressor Free Days [ Time Frame: Study start to Day 29 ]
    Number of days without use of vasopressor therapy

  5. Hospital Free Days [ Time Frame: Study start to Day 29 ]
    Number of days Partcipant is out of the hospital

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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).

  12. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377620


Locations
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Sponsors and Collaborators
Incyte Corporation
  Study Documents (Full-Text)

Documents provided by Incyte Corporation:
Study Protocol  [PDF] June 2, 2020
Statistical Analysis Plan  [PDF] February 22, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04377620    
Other Study ID Numbers: INCB 18424-369
First Posted: May 6, 2020    Key Record Dates
Results First Posted: January 19, 2022
Last Update Posted: January 19, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Cytokine storm
COVID-19
ARDS
 SARS-CoV-2
ruxolitinib
pneumonia
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action