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

NCT ID: NCT04331665

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-21
• Study Completion Date: 2021-03-24

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.

Conditions

COVID-19; Pneumonia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ruxolitinib to prevent COVID-19 pneumonia

All 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.

Group Type: EXPERIMENTAL

Ruxolitinib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

JAKAVI

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Chan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Vikas Gupta, M.D.

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35695334 (View on PubMed)

Other Identifiers

20-5315

Identifier Type: OTHER

Identifier Source: secondary_id

U-DEPLOY: RUX-COVID

Identifier Type: -

Identifier Source: org_study_id