Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
- Registration Number
- NCT04377620
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 211
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + Standard of Care (SoC) Placebo Matching Placebo will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. Ruxolitinib 5mg + Standard of Care (SoC) Ruxolitinib Ruxolitinib 5mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib Ruxolitinib 15mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Have Died Due to Any Cause 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
Name Time Method Number of Ventilator Free Days Study start to Day 29 Number of days participant did not require mechanical ventilation
Oxygen Free Days Study start to Day 29 Number of days participant did not receive supplemental oxygen
Vasopressor Free Days Study start to Day 29 Number of days without use of vasopressor therapy
Hospital Free Days Study start to Day 29 Number of days Partcipant is out of the hospital
Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale 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
Number of ICU Free Days Study start to Day 29 Number of days participant is out of the ICU
Percentage of Participants With the COVID-19 Ordinal Scale Reported 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
Change in SOFA Score 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).
Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale 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
Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events Study start to Day 29 Treatment-emergent AEs are judged as related by the investigator or have a missing causality.
Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale 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
Change in the COVID-19 9-point Ordinal Scale 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
Trial Locations
- Locations (36)
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Wenatchee Valley Hospital and Clinics
🇺🇸Wenatchee, Washington, United States
Northshore University Health System
🇺🇸Chicago, Illinois, United States
West Penn Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Teradan Clinical Trials
🇺🇸Brandon, Florida, United States
Honor Health Research Institute
🇺🇸Scottsdale, Arizona, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Indiana University Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Allegheny Health Network
🇺🇸Wexford, Pennsylvania, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Texas Health Science Center At Houston - McGovern Medical School
🇺🇸Houston, Texas, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Mercy Research
🇺🇸Springfield, Missouri, United States
Indiana University Health Central Indiana Cancer Centers
🇺🇸Indianapolis, Indiana, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Rutgers Njms Clinical Research Unit
🇺🇸Newark, New Jersey, United States
Lahey Hospital & Medical Center
🇺🇸Burlington, Massachusetts, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
East Jefferson General Hospital
🇺🇸Metairie, Louisiana, United States
Healthpartners Cancer Care Center - Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Jefferson University Hospitals
🇺🇸Philadelphia, Pennsylvania, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Kettering Cancer Care
🇺🇸Dayton, Ohio, United States
St David'S Medical Center
🇺🇸Austin, Texas, United States
University of Texas Health Science Cente
🇺🇸San Antonio, Texas, United States
Sbih City Hospital 15
🇷🇺Saint Petersburg, Russian Federation
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Aurora Research Institute
🇺🇸Milwaukee, Wisconsin, United States