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.
Drug: Placebo
Placebo administered BID approximately 12 hours apart
Drug: Ruxolitinib
Ruxolitinb administered BID approximately 12 hours apart
Other Name: Array
Inclusion Criteria:
- 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.
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.
- 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.
Honor Health Research Institute
Scottsdale, Arizona, United States
Sharp Memorial Hospital
San Diego, California, United States
Georgetown University Hospital
Washington, District of Columbia, United States
Teradan Clinical Trials
Brandon, Florida, United States
University of Florida
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Northshore University Health System
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Indiana University Health Central Indiana Cancer Centers
Indianapolis, Indiana, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Healthpartners Cancer Care Center - Regions Hospital
Saint Paul, Minnesota, United States
Mercy Research
Springfield, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers Njms Clinical Research Unit
Newark, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Kettering Cancer Care
Dayton, Ohio, United States
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
Allegheny Health Network
Wexford, Pennsylvania, United States
St David'S Medical Center
Austin, Texas, United States
University of Texas Health Science Center At Houston - McGovern Medical School
Houston, Texas, United States
University of Texas Health Science Cente
San Antonio, Texas, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States
Aurora Research Institute
Milwaukee, Wisconsin, United States
Sbih City Hospital 15
Saint Petersburg, Russian Federation