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.
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.
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
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.
Princess Margaret Cancer Centre
Toronto, Ontario, Canada