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
- 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.
Most Recent Events
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 |
|---|---|---|
| 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
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 2023;.
Available from: URL: http://clinicaltrials.gov
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