COVID-19

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

Incyte Study ID:
INCB 18424-369
CT.gov ID:
NCT04377620
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
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Statistical Analysis Plan (SAP)
Available Languages: English
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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • COVID-19
    • PRODUCT
  • Drug: Placebo
  • Drug: Ruxolitinib
    • COLLABORATORS
    N/A
    DATE
    May 2020 - Feb 2021
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    12+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    West Penn Hospital
    Pittsburgh, PA, US, 15224
    Name
    JEFFERSON UNIVERSITY HOSPITALS
    PHILADELPHIA, PA, US, 19107
    Name
    BOSTON MEDICAL CENTER
    BOSTON, MA, US, 02118
    Name
    Tampa General Hospital
    Tampa, FL, US, 33606
    Name
    UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL
    WORCESTER, MA, US, 01655
    Name
    LAHEY HOSPITAL & MEDICAL CENTER
    BURLINGTON, MA, US, 01805

    Key Inclusion and Exclusion 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.

    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.

    Protocol Summary

    Incyte Study ID:
    INCB 18424-369
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Double (Participant, Investigator)
    Interventions:
    Drug
    Enrollment:
    211
    Primary Outcome
    Open

    Proportion of participants who have died due to any cause

    Timeframe: Up to Day 29

    Secondary Outcome
    Open

    Number of Ventilator free days

    Timeframe: Day 29

    Number of ICU free days

    Timeframe: Day 29

    Oxygen free days

    Timeframe: Day 29

    Vasopressor free days

    Timeframe: Day 29

    Hospital free days

    Timeframe: Day 29

    Improvement in the COVID-19 ordinal scale

    Timeframe: Day 15 and 29

    Change in SOFA Score

    Timeframe: from baseline to Days 3, 5, 8, 11, 15, and 29

    Number of treatment-related adverse events

    Timeframe: Day 29