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

Study Overview
=================
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.

Official Title
-----------------
A Single Arm Open-label Clinical Study to Investigate the Efficacy and Safety of Ruxolitinib for the Treatment of COVID-19 Pneumonia

Conditions
-----------------
COVID-19, Pneumonia

Intervention / Treatment
-----------------
* Drug: Ruxolitinib


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ruxolitinib to prevent COVID-19 pneumonia<br>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<br>* 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.<br>* Other names: JAKAVI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with COVID-19 pneumonia who become critically ill (defined as requiring mechanical ventilation and/or FiO2 of 60% of more) |  | 6 months | 
| Number of adverse events |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality rate |  | 9 months | 
| Average duration of hospital stay |  | 9 months |