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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04331665
• Other study ID #: U-DEPLOY: RUX-COVID
• Secondary ID: 20-5315
• Status: Terminated
• Phase: N/A
• Start date: May 21, 2020
• Est. completion date: March 24, 2021

Study information

• Verified date: August 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 24, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of adverse events		9 months
Secondary	All cause mortality rate		9 months
Secondary	Average duration of hospital stay		9 months