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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT04377620
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo administered BID approximately 12 hours apart
  • Ruxolitinib — DRUG
    Ruxolitinb administered BID approximately 12 hours apart

Study Details

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.

Key Dates

Start date
May 24, 2020
Status verified
Jan 2022
Primary completion
Feb 26, 2021
Completion
Feb 26, 2021

Study Design

Enrollment
211 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Percentage of Participants Who Have Died Due to Any Cause [ Time Frame: Study start to Day 29 ]

Locations (35)

FacilityCityStateZIPSite coordinators
Honor Health Research InstituteScottsdaleArizona85258-
Sharp Memorial HospitalSan DiegoCalifornia92123-
Georgetown University HospitalWashington D.C.District of Columbia20007-
Teradan Clinical TrialsBrandonFlorida33511-
University of FloridaGainesvilleFlorida32610-
Tampa General HospitalTampaFlorida33606-
University of South FloridaTampaFlorida33613-
Northshore University Health SystemChicagoIllinois60678-
Loyola University Medical CenterMaywoodIllinois60153-
Indiana University Health Central Indiana Cancer CentersIndianapolisIndiana46219-
Indiana University Simon Cancer CenterIndianapolisIndiana46202-
East Jefferson General HospitalMetairieLouisiana70006-
Johns Hopkins UniversityBaltimoreMaryland21224-
Boston Medical CenterBostonMassachusetts02118-
Lahey Hospital & Medical CenterBurlingtonMassachusetts01805-
University of Massachusetts Medical SchoolWorcesterMassachusetts01655-
Healthpartners Cancer Care Center - Regions HospitalSaint PaulMinnesota55101-
Mercy ResearchSpringfieldMissouri65804-
Hackensack University Medical CenterHackensackNew Jersey07601-
Rutgers Njms Clinical Research UnitNewarkNew Jersey07103-
Holy Name Medical CenterTeaneckNew Jersey07666-
University of Rochester Medical CenterRochesterNew York14642-
Duke University Medical CenterDurhamNorth Carolina27710-
East Carolina UniversityGreenvilleNorth Carolina27858-
University of CincinnatiCincinnatiOhio45219-
Kettering Cancer CareDaytonOhio45429-
Jefferson University HospitalsPhiladelphiaPennsylvania19107-
Temple UniversityPhiladelphiaPennsylvania19140-
West Penn HospitalPittsburghPennsylvania15224-
Allegheny Health NetworkWexfordPennsylvania15090-
St David'S Medical CenterAustinTexas78705-
University of Texas Health Science Center At Houston - McGovern Medical SchoolHoustonTexas77030-
University of Texas Health Science CenteSan AntonioTexas78229-
Wenatchee Valley Hospital and ClinicsWenatcheeWashington98801-
Aurora Research InstituteMilwaukeeWisconsin53233-

Find similar trials in Scottsdale, AZ

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Honor Health Research Institute· Scottsdale, AZSharp Memorial Hospital· San Diego, CAGeorgetown University Hospital· Washington D.C., DCTeradan Clinical Trials· Brandon, FLUniversity of Florida· Gainesville, FLTampa General Hospital· Tampa, FL

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