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Trial record 1 of 1 for:    NCT04377620
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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 : Recruiting
First Posted : May 6, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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 available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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
Estimated Primary Completion Date : July 29, 2020
Estimated Study Completion Date : July 29, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of Ventilator free days [ Time Frame: Day 29 ]
    Number of days participant did not require mechanical ventilation

  2. Number of ICU free days [ Time Frame: Day 29 ]
    Number of days participant is out of the ICU

  3. Oxygen free days [ Time Frame: Day 29 ]
    Number of days participant did not receive supplemental oxygen

  4. Vasopressor free days [ Time Frame: Day 29 ]
    Number of days without use of vasopressor therapy

  5. Hospital free days [ Time Frame: Day 29 ]
    Number of days Partcipant is out of the hospital

  6. 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

  7. 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.

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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.

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, nitric oxide therapy or high-frequency oscillatory ventilation.
  • 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.

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


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com

Locations
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United States, Pennsylvania
West Penn Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Incyte Corporation
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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
Last Update Posted: May 29, 2020
Last Verified: May 2020
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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Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action