A Single Arm Open-label Clinical Study to Investigate the Efficacy and Safety of Ruxolitinib for the Treatment of COVID-19 Pneumonia
Latest Information Update: 24 Aug 2021
At a glance
- Drugs Ruxolitinib (Primary)
- Indications COVID 2019 infections; Pneumonia
- Focus Adverse reactions; Therapeutic Use
Most Recent Events
- 13 Aug 2021 Status changed from completed to discontinued.
- 31 May 2021 Status changed from not yet recruiting to completed.
- 09 Apr 2020 Planned initiation date changed from 6 Apr 2020 to 20 Apr 2020.
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.
Comments
According to ClinicalTrials.gov, the study was stopped due to 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.
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
Actual: 3
- 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
Actual : 21 May 2020
-
Primary Completion Dates
Planned : 30 Oct 2020
Actual : 05 Jan 2021
-
End Dates
Planned : 31 Jan 2021
Actual : 24 Mar 2021
Other Details
- Design open; prospective
- Phase of Trial Phase II
- Location Canada
- Focus Adverse reactions; Therapeutic Use
Interventions
| Drugs | Route | Formulation | Target |
|---|---|---|---|
|
Ruxolitinib Primary Drug
|
Oral | Tablet | Janus kinase 1, Janus kinase 2 |
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
show details
steven.chan@uhn.ca 416-946-4501 Ext: 2253 |
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 |
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Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 24 Aug 2021 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 24 Aug 2021 |
| 13 Aug 2021 | Status change - discontinued | Status changed from completed to discontinued. Updated 24 Aug 2021 |
| 31 May 2021 | Status change - completed | Status changed from not yet recruiting to completed. Updated 07 Jun 2021 |
| 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
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2024;.
Available from: URL: http://clinicaltrials.gov
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