Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 1, 2020
First Posted Date  ICMJE April 2, 2020
Last Update Posted Date April 13, 2020
Estimated Study Start Date  ICMJE April 20, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • 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 ]
  • Number of adverse events [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • All cause mortality rate [ Time Frame: 9 months ]
  • Average duration of hospital stay [ Time Frame: 9 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • All cause mortality rate [ Time Frame: 9 months ]
  • Average duration of hospital stay [ Time Frame: 9 months ]
  • Number of occurrence of secondary infections [ Time Frame: 9 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia
Official Title  ICMJE A Single Arm Open-label Clinical Study to Investigate the Efficacy and Safety of Ruxolitinib for the Treatment of COVID-19 Pneumonia
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Pneumonia
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Ruxolitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Steven Chan, M.D. 416-946-2000 steven.chan@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04331665
Other Study ID Numbers  ICMJE U-DEPLOY: RUX-COVID
20-5315 ( Other Identifier: University Health Network )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven Chan, M.D. Princess Margaret Cancer Centre
Principal Investigator: Vikas Gupta, M.D. Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP