COVID-19NCT04331665
Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia
A study testing Ruxolitinib in people with COVID-19 and Pneumonia, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- What is being tested?
- Ruxolitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 21 May 2020to 24 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COVID-19 infection diagnosed by nasopharyngeal sample
- Need for supplemental oxygen to maintain oxygen saturation > 93%
- 12 years of age or older
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm Open-label Clinical Study to Investigate the Efficacy and Safety of Ruxolitinib for the Treatment of COVID-19 Pneumonia
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.
Read the 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.
- Being tested
- Ruxolitinib
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called JAKAVI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with COVID-19 pneumonia who become critically ill (defined as requiring mechanical ventilation and/or FiO2 of 60% of more)
Measured: 6 months
Number of adverse events
Measured: 9 months
Secondary outcomes (2)
All cause mortality rate
Measured: 9 months
Average duration of hospital stay
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start21 May 2020
- Primary completion5 Jan 2021
- Study completion24 Mar 2021
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Chan, M.D., Principal investigator, Princess Margaret Cancer CentreVikas Gupta, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331665
- Sponsor's protocol ID
- U-DEPLOY: RUX-COVID
- Other IDs
- 20-5315
- Status last verified
- Aug 2021
- First submitted
- 1 Apr 2020
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35695334
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Open-label Clinical Study to Investigate the Efficacy and Safety of Ruxolitinib for the Treatment of COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04331665
- Acronym / sponsor ID
- U-DEPLOY: RUX-COVID
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib to prevent COVID-19 pneumonia | Experimental | Drug: RuxolitinibAll 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- COVID-19 infection diagnosed by nasopharyngeal sample
- Need for supplemental oxygen to maintain oxygen saturation > 93%
- 12 years of age or older
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibAlso: JAKAVIRuxolitinib 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. | Drug | Ruxolitinib to prevent COVID-19 pneumonia |
Primary outcome
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
2 secondary outcomes
All cause mortality rate
Time frame: 9 months
Average duration of hospital stay
Time frame: 9 months
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Derived from this study: PubMed 35695334Kramer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Chan, M.D. principal investigator
Princess Margaret Cancer Centre
Vikas Gupta, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ruxolitinib in people with COVID-19 and Pneumonia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04331665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.