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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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 ]
- All cause mortality rate [ Time Frame: 9 months ]
- Average duration of hospital stay [ Time Frame: 9 months ]
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
|Contact: Steven Chan, M.D.||email@example.com|
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Steven Chan, M.D. firstname.lastname@example.org|
|Principal Investigator: Steven Chan, M.D.|
|Principal Investigator: Vikas Gupta, M.D.|
|Principal Investigator:||Steven Chan, M.D.||Princess Margaret Cancer Centre|
|Principal Investigator:||Vikas Gupta, M.D.||Princess Margaret Cancer Centre|