Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia
- Sponsor
- University Health Network, Toronto
- Study ID
- NCT04331665
- Status
- Terminated
Conditions
- COVID-19
- Pneumonia
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ruxolitinib — DRUGRuxolitinib 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.
Study Details
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.
Key Dates
- Start date
- May 21, 2020
- Status verified
- Aug 2021
- Primary completion
- Jan 5, 2021
- Completion
- Mar 24, 2021
Study Design
- Enrollment
- 3 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Ruxolitinib to prevent COVID-19 pneumoniaAll 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.
Primary Outcome Measure
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 ]
Related Studies
- Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES)Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland
- Study of Lung Proteins in Patients With PneumoniaRecruiting · National Institutes of Health Clinical Center (CC) · Bethesda, Maryland
- Viral Infections in Healthy and Immunocompromised HostsRecruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland
- The Role of Circadian Clock Proteins in Innate and Adaptive ImmunityRecruiting · Washington University School of Medicine · St Louis, Missouri