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

Trial Profile

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

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 14 Apr 2020

At a glance

  • Drugs Ruxolitinib (Primary)
  • Indications COVID 2019 infections; Pneumonia
  • Focus Adverse reactions; Therapeutic Use
  • Most Recent Events

    • 09 Apr 2020 Planned initiation date changed from 6 Apr 2020 to 20 Apr 2020.
    • 06 Apr 2020 New trial record

Trial Overview

Purpose

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.

Primary Endpoints

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

Number of adverse events

time_frame: 9 months

Other Endpoints

All cause mortality rate

time_frame: 9 months

Average duration of hospital stay

time_frame: 9 months [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 64

  • Sex male & female
  • Age Group ≥ 12 years; adolescent; adult; child

Patient Inclusion Criteria

- COVID-19 infection diagnosed by nasopharyngeal sample - Need for supplemental oxygen to maintain oxygen saturation > 93% - 12 years of age or older

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT04331665 ClinicalTrials.gov: US National Institutes of Health
U-DEPLOY-RUX-COVID -

Trial Dates

  • Initiation Dates

    Planned : 20 Apr 2020

  • Primary Completion Dates

    Planned : 30 Oct 2020

  • End Dates

    Planned : 31 Jan 2021

Other Details

  • Design open; prospective
  • Phase of Trial Phase II
  • Location Canada
  • Focus Adverse reactions; Therapeutic Use

Interventions

Drugs Route Formulation
RuxolitinibPrimary Drug Oral Tablet

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.
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.) Other Name: JAKAVI

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Steven Chan, M.D.
416-946-4501 2253
steven.chan@uhn.ca
416-946-4501 Ext: 2253
show details
Princess Margaret Cancer Centre Canada
Vikas Gupta, M.D. Princess Margaret Cancer Centre Canada

Centres

Centre Name Location Trial Centre Country
Princess Margaret Cancer Centre Toronto, Ontario Canada
University Health Network, Toronto
-
-

Trial History

Event Date Event Type Comment
14 Apr 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 14 Apr 2020
09 Apr 2020 Other trial event Planned initiation date changed from 6 Apr 2020 to 20 Apr 2020. Updated 14 Apr 2020
06 Apr 2020 New trial record New trial record Updated 06 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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