NCT04331665

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 21, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2021

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

April 1, 2020

Last Update Submit

August 13, 2021

Conditions

COVID-19Pneumonia

Outcome Measures

Primary Outcomes (2)

  • 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

  • Number of adverse events

    9 months

Secondary Outcomes (2)

  • All cause mortality rate

    9 months

  • Average duration of hospital stay

    9 months

Study Arms (1)

Ruxolitinib to prevent COVID-19 pneumonia

EXPERIMENTAL

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.

Drug: Ruxolitinib

Interventions

RuxolitinibDRUG

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.

Also known as: JAKAVI
Ruxolitinib to prevent COVID-19 pneumonia

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • COVID-19 infection diagnosed by nasopharyngeal sample
  • Need for supplemental oxygen to maintain oxygen saturation \> 93%
  • years of age or older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 35695334DERIVED

MeSH Terms

Conditions

COVID-19Pneumonia

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Pneumonia, ViralRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Steven Chan, M.D.

    Princess Margaret Cancer Centre

    PRINCIPAL INVESTIGATOR

  • Vikas Gupta, M.D.

    Princess Margaret Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 2, 2020

Study Start

May 21, 2020

Primary Completion

January 5, 2021

Study Completion

March 24, 2021

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)