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Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia

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ClinicalTrials.gov Identifier: NCT04331665
Recruitment Status : Not yet recruiting
First Posted : April 2, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief Summary:

The purpose of this study is to determine the safety and efficacy of the drug ruxolitinib in people diagnosed with COVID-19 pneumonia by determining the number of people whose conditions worsen (requiring machines to help with breathing or needing supplemental oxygen) while receiving the drug.

This is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps to facilitate timely conduct of studies across the University Health Network and other centers.


Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: Ruxolitinib Not Applicable

Detailed Description:
Multifocal interstitial pneumonia is the most common cause of deterioration in people with COVID-19. This is attributed to a severe reaction where releases too many cytokines (proteins that play an important role in immune responses) which rush into the lungs resulting in lung inflammation and fluid buildup. This can lead to damage to the lungs and leading to breathing problems. Ruxolitinib when given early in the disease, may prevent the overproduction of cytokines which, in turn, may prevent lung damage.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm Open-label Clinical Study to Investigate the Efficacy and Safety of Ruxolitinib for the Treatment of COVID-19 Pneumonia
Estimated Study Start Date : April 20, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ruxolitinib to prevent COVID-19 pneumonia
All participants will receive ruxolitinib at at 10 mg, twice a day, for 14 days, followed by 5 mg, twice a day, for 2 days and 5 mg, once daily, for 1 day.
 Drug: Ruxolitinib
Ruxolitinib is an inhibitor of JAK1 and JAK2 (proteins important in cell signalling) approved for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.
Other Name: JAKAVI


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with COVID-19 pneumonia who become critically ill (defined as requiring mechanical ventilation and/or FiO2 of 60% of more) [ Time Frame: 6 months ]
  2. Number of adverse events [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. All cause mortality rate [ Time Frame: 9 months ]
  2. Average duration of hospital stay [ Time Frame: 9 months ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COVID-19 infection diagnosed by nasopharyngeal sample
  • Need for supplemental oxygen to maintain oxygen saturation > 93%
  • 12 years of age or older

Exclusion Criteria:

  • Neutrophils < 1 x 10^9/L
  • Platelets < 50 x 10^9/L
  • Serum total bilirubin >2.0 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 5x ULN
  • Creatinine clearance (CrCl) < 15 mL/minute
  • Pregnant women
  • Known HBV or HIV infection
  • Signs and symptoms of Varicella Zoster Virus (VZV) infection
  • Patients requiring invasive mechanical ventilation. Patients requiring non-invasive mechanical ventilation (e.g., BiPAP) are eligible.
  • Patients who require supplemental oxygen support prior to COVID-19 infection.
  • Patients who are on ruxolitinib or similiar drugs.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331665


Contacts
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Contact: Steven Chan, M.D. 416-946-2000 steven.chan@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Contact: Steven Chan, M.D.       steven.chan@uhn.ca   
Principal Investigator: Steven Chan, M.D.         
Principal Investigator: Vikas Gupta, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Steven Chan, M.D. Princess Margaret Cancer Centre
Principal Investigator: Vikas Gupta, M.D. Princess Margaret Cancer Centre
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04331665    
Other Study ID Numbers: U-DEPLOY: RUX-COVID
20-5315 ( Other Identifier: University Health Network )
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections