Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia
Primary Purpose
COVID-19, Pneumonia
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ruxolitinib
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility 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.
Sites / Locations
- Princess Margaret Cancer Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ruxolitinib to prevent COVID-19 pneumonia
Arm Description
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.
Outcomes
Primary Outcome Measures
Proportion of patients with COVID-19 pneumonia who become critically ill (defined as requiring mechanical ventilation and/or FiO2 of 60% of more)
Number of adverse events
Secondary Outcome Measures
All cause mortality rate
Average duration of hospital stay
Full Information
NCT ID
NCT04331665
First Posted
April 1, 2020
Last Updated
August 13, 2021
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04331665
Brief Title
Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia
Official Title
A Single Arm Open-label Clinical Study to Investigate the Efficacy and Safety of Ruxolitinib for the Treatment of COVID-19 Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
A Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint. With this news, recruitment was stopped for this study.
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
January 5, 2021 (Actual)
Study Completion Date
March 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ruxolitinib to prevent COVID-19 pneumonia
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Ruxolitinib
Other Intervention Name(s)
JAKAVI
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Number of adverse events
Time Frame
9 months
Secondary Outcome Measure Information:
Title
All cause mortality rate
Time Frame
9 months
Title
Average duration of hospital stay
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Chan, M.D.
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vikas Gupta, M.D.
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35695334
Citation
Kramer A, Prinz C, Fichtner F, Fischer AL, Thieme V, Grundeis F, Spagl M, Seeber C, Piechotta V, Metzendorf MI, Golinski M, Moerer O, Stephani C, Mikolajewska A, Kluge S, Stegemann M, Laudi S, Skoetz N. Janus kinase inhibitors for the treatment of COVID-19. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD015209. doi: 10.1002/14651858.CD015209.
Results Reference
derived
Learn more about this trial
Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia
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