Clinical trial NCT04331665: Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia
Official title: A Single Arm Open-label Clinical Study to Investigate the Efficacy and Safety of Ruxolitinib for the Treatment of COVID-19 Pneumonia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COVID-19
Pneumonia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 3
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of patients with COVID-19 pneumonia who become critically ill (defined as requiring mechanical ventilation and/or FiO2 of 60% of more)
timeFrame: 6 months
measure: Number of adverse events
timeFrame: 9 months
Secondary outcomes:
measure: All cause mortality rate
timeFrame: 9 months
measure: Average duration of hospital stay
timeFrame: 9 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Steven Chan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Cancer Centre
name: Vikas Gupta, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kramer A, Prinz C, Fichtner F, Fischer AL, Thieme V, Grundeis F, Spagl M, Seeber C, Piechotta V, Metzendorf MI, Golinski M, Moerer O, Stephani C, Mikolajewska A, Kluge S, Stegemann M, Laudi S, Skoetz N. Janus kinase inhibitors for the treatment of COVID-19. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD015209. doi: 10.1002/14651858.CD015209.