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History of Changes for Study: NCT04377620
Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
Latest version (submitted January 14, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 4, 2020 None (earliest Version on record)
2 May 6, 2020 Recruitment Status, Study Status and Contacts/Locations
3 May 27, 2020 Study Status
4 June 3, 2020 Eligibility, Study Status and Contacts/Locations
5 June 15, 2020 Study Status
6 October 16, 2020 Study Status and Contacts/Locations
7 December 17, 2020 Contacts/Locations and Study Status
8 March 11, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
9 November 17, 2021
Quality Control Review has not concluded Returned: November 23, 2021
Outcome Measures, Study Status, Document Section
10 December 6, 2021
Quality Control Review has not concluded Returned: December 7, 2021
Outcome Measures, Study Status and Adverse Events
11 December 15, 2021
Quality Control Review has not concluded Returned: December 17, 2021
Outcome Measures, Adverse Events and Study Status
12 January 11, 2022
Quality Control Review has not concluded Returned: January 13, 2022
Study Status and Adverse Events
13 January 14, 2022 Study Status, Adverse Events
Comparison Format:

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Study NCT04377620
Submitted Date:  May 4, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: INCB 18424-369
Brief Title: Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2020
Overall Status: Not yet recruiting
Study Start: May 6, 2020
Primary Completion: July 29, 2020 [Anticipated]
Study Completion: July 29, 2020 [Anticipated]
First Submitted: May 4, 2020
First Submitted that
Met QC Criteria:
May 4, 2020
First Posted: May 6, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
May 4, 2020
Last Update Posted: May 6, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Incyte Corporation
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: COVID-19
Keywords: Cytokine storm
COVID-19
ARDS
SARS-CoV-2
ruxolitinib
pneumonia
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 500 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Incyte Corporation Call Center (US)
Telephone: 1.855.463.3463
Email: medinfo@incyte.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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