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

• Status: Terminated
• Trial end date: 2021-03-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto

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.