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

Primary Purpose

COVID-19, Pneumonia

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Ruxolitinib

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ruxolitinib to prevent COVID-19 pneumonia

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of patients with COVID-19 pneumonia who become critically ill (defined as requiring mechanical ventilation and/or FiO2 of 60% of more)

Number of adverse events

Secondary Outcome Measures

All cause mortality rate

Average duration of hospital stay

Full Information

NCT ID

NCT04331665

First Posted

April 1, 2020

Last Updated

August 13, 2021

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT04331665

Brief Title

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

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Terminated

Why Stopped

A Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint. With this news, recruitment was stopped for this study.

Study Start Date

May 21, 2020 (Actual)

Primary Completion Date

January 5, 2021 (Actual)

Study Completion Date

March 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Pneumonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ruxolitinib to prevent COVID-19 pneumonia

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Ruxolitinib

Other Intervention Name(s)

JAKAVI

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Title

Number of adverse events

Time Frame

9 months

Secondary Outcome Measure Information:

Title

All cause mortality rate

Time Frame

9 months

Title

Average duration of hospital stay

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Chan, M.D.

Organizational Affiliation

Princess Margaret Cancer Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vikas Gupta, M.D.

Organizational Affiliation

Princess Margaret Cancer Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35695334

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.

Results Reference

derived

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

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