Severe Acute Respiratory Syndrome Coronavirus 2Phase 2/3RUXO-COVIDNCT04477993
Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19
A Phase 2/3 study testing Janus Kinase Inhibitor (ruxolitinib) in people with Severe Acute Respiratory Syndrome Coronavirus 2 and SARS-CoV2, run by Vanderson Geraldo Rocha at 1 site in Brazil.
Trial summary
The COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV2
- What is being tested?
- Janus Kinase Inhibitor (ruxolitinib)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Aug 2020to 29 Mar 2021
- Phase
- Phase 2/3
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized with SARS-CoV-2 pneumonia confirmed by RT-PCR or serology (IgA);
- PaO2/FiO2 < 300 (not fully explained by heart failure or volume overload) or SpO2 < 90% on room air.
Who cannot join
- Symptom onset > 14 days;
- Neutrophil count < 1,000/mm3;
- Platelets < 50,000/mm3;
- ICU care at enrollment;
- On invasive mechanical ventilation at enrollment;
- Current use of experimental therapy for COVID-19 (except: azithromycin or corticosteroids)
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- Uncontrolled arterial hypertension;
- Current or previous use of systemic immunosuppressive therapy in the last 30 days;
- Pregnancy or lactation;
- Estimated creatinine clearance < 30 mL/min or receiving CRRT or intermittent hemodialysis;
- Allergy to ruxolitinib;
- Active tuberculosis;
- HIV seropositivity;
- Prior history of progressive multifocal leukoencephalopathy;
- Use of any JAK inhibitor in the last 30 days before study enrollment;
- Not qualifying according to investigators' perception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind Clinical Trial of Ruxolitinib in Patients With Acute Respiratory Disorder Syndrome Due to SARS-CoV-2 Infection
The COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.
- Being tested
- Janus Kinase Inhibitor (ruxolitinib), Placebo
- Keywords
- SARS-CoV2, Severe Acute Respiratory Syndrome Coronavirus 2, Janus Kinase Inhibitors, Safety, Clinical Efficacy, Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Janus Kinase Inhibitor (ruxolitinib)Drug
5 mg P.O. b.i.d. for 14 days. Dose reduction will occur if neutrophils < 500/mm3 or platelets <50,000/mm3.
PlaceboOther
Placebo tablets P.O. b.i.d. for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group - ruxolitinib | Experimental | Ruxolitinib 5 mg PO b.i.d. for 14 days Receives: Drug: Janus Kinase Inhibitor (ruxolitinib) |
| Placebo Group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite outcome of death or ICU admission or mechanical ventilation at day 14.
Measured: 14 days
Secondary outcomes (45)
A composite outcome of death or ICU admission or mechanical ventilation at day 28
Measured: 28 days
Time to treatment failure
ICU admission, mechanical ventilation, death or consent withdrawal
Measured: 28 days
Overall survival at days 14 and 28
Measured: 14 and 28 days
Cumulative incidence of ICU admission rate at days 14 and 28
Measured: 14 and 28 days
Cumulative incidence of mechanical ventilation at days 14 and 28
Measured: 14 and 28 days
Duration of hospital stay
Measured: 28 days
Duration of ICU stay
Measured: 28 days
Duration of mechanical ventilation
Measured: 28 days
Duration of non-invasive ventilation
Measured: 28 days
Secondary hemophagocytic syndrome rate
Measured: 28 days
Cumulative incidence nosocomial infection rate at days 14 and 28
Measured: 14 and 28 days
Incidence of discontinuation of oxygen supplementation at days 14 and 28
Measured: 14 and 28 days
Rate of grade 1-2 and 3-5 emerging adverse events at day 28
Measured: 28 days
Cumulative dose of methylprednisolone at days 14 and 28
Measured: 14 and 28 days
Change in PaO2/FiO2 ratio from baseline to days 14 and 28
Measured: 14 and 28 days
Change in interleukin 6 levels [pg/mL] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in d-dimer levels [ng/mL] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in fibrinogen levels [mg/dL] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in ferritin levels [ng/mL] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in C reactive protein levels [mg/L] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in alanine aminotransferase [U/L] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in aspartate aminotransferase [U/L] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in creatinine levels [mg/dL] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in glucose levels [mg/dL] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in hemoglobin levels [g/dL] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in platelet count [x10ˆ3/mmˆ3] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in absolute neutrophil count [x10ˆ3/mmˆ3] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in absolute neutrophil count [/mmˆ3] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in absolute lymphocyte count [/mmˆ3] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in prothrombin time ratio from baseline to days 14 and 28
Measured: 14 and 28 days
Change in partial thromboplastin time ratio from baseline to days 14 and 28
Measured: 14 and 28 days
Change in bilirubin [mg/dl] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in lactate dehydrogenase [U/L] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in CPK-MB [ng/mL] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in troponin [ng/mL] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in von Willebrand factor antigen level (VWF:Ag) [%] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in von Willebrand factor activity (ristocetin cofactor) [%] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in ADAMTS-13 [%] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in von Willebrand multimeters from baseline to days 14 and 28
Measured: 14 and 28 days
Change in plasminogen activator inhibitor-1 levels [ng/mL] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in E-selectin levels [ng/mL] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in P-selectin levels [ng/mL] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in endothelin [fmol/mL] from baseline to days 14 and 28
Measured: 14 and 28 days
Change in circulating microparticles from baseline to days 14 and 28
Measured: 14 and 28 days
Change in thromboelastography from baseline to days 14 and 28
Measured: 14 and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start14 Aug 2020
- Primary completion29 Mar 2021
- Study completion29 Mar 2021
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2Studies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderson Geraldo Rocha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vanderson Geraldo Rocha, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477993
- Sponsor's protocol ID
- 32894720.3.0000.0068
- Acronym
- RUXO-COVID
- Status last verified
- Apr 2021
- First submitted
- 13 Jul 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind Clinical Trial of Ruxolitinib in Patients With Acute Respiratory Disorder Syndrome Due to SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04477993
- Acronym / sponsor ID
- RUXO-COVID / 32894720.3.0000.0068
- Keywords
- SARS-CoV2, Severe Acute Respiratory Syndrome Coronavirus 2, Janus Kinase Inhibitors, Safety, Clinical Efficacy, Clinical Trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Vanderson Geraldo RochaUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 20 Jul 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 COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group - ruxolitinib | Experimental | Drug: Janus Kinase Inhibitor (ruxolitinib)Ruxolitinib 5 mg PO b.i.d. for 14 days |
| Placebo Group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients hospitalized with SARS-CoV-2 pneumonia confirmed by RT-PCR or serology (IgA);
- PaO2/FiO2 < 300 (not fully explained by heart failure or volume overload) or SpO2 < 90% on room air.
Key exclusion criteria (16 listed)
- Symptom onset > 14 days;
- Neutrophil count < 1,000/mm3;
- Platelets < 50,000/mm3;
- ICU care at enrollment;
- On invasive mechanical ventilation at enrollment;
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 |
|---|---|---|
| Janus Kinase Inhibitor (ruxolitinib)5 mg P.O. b.i.d. for 14 days. Dose reduction will occur if neutrophils < 500/mm3 or platelets <50,000/mm3. | Drug | Experimental Group - ruxolitinib |
| PlaceboPlacebo tablets P.O. b.i.d. for 14 days. | Other | Placebo Group |
Primary outcome
A composite outcome of death or ICU admission or mechanical ventilation at day 14.
Time frame: 14 days
45 secondary outcomes
A composite outcome of death or ICU admission or mechanical ventilation at day 28
Time frame: 28 days
Time to treatment failure
Time frame: 28 days
Overall survival at days 14 and 28
Time frame: 14 and 28 days
Cumulative incidence of ICU admission rate at days 14 and 28
Time frame: 14 and 28 days
Cumulative incidence of mechanical ventilation at days 14 and 28
Time frame: 14 and 28 days
Duration of hospital stay
Time frame: 28 days
Duration of ICU stay
Time frame: 28 days
Duration of mechanical ventilation
Time frame: 28 days
Duration of non-invasive ventilation
Time frame: 28 days
Secondary hemophagocytic syndrome rate
Time frame: 28 days
Cumulative incidence nosocomial infection rate at days 14 and 28
Time frame: 14 and 28 days
Incidence of discontinuation of oxygen supplementation at days 14 and 28
Time frame: 14 and 28 days
Rate of grade 1-2 and 3-5 emerging adverse events at day 28
Time frame: 28 days
Cumulative dose of methylprednisolone at days 14 and 28
Time frame: 14 and 28 days
Change in PaO2/FiO2 ratio from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in interleukin 6 levels [pg/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in d-dimer levels [ng/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in fibrinogen levels [mg/dL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in ferritin levels [ng/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in C reactive protein levels [mg/L] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in alanine aminotransferase [U/L] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in aspartate aminotransferase [U/L] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in creatinine levels [mg/dL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in glucose levels [mg/dL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in hemoglobin levels [g/dL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in platelet count [x10ˆ3/mmˆ3] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in absolute neutrophil count [x10ˆ3/mmˆ3] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in absolute neutrophil count [/mmˆ3] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in absolute lymphocyte count [/mmˆ3] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in prothrombin time ratio from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in partial thromboplastin time ratio from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in bilirubin [mg/dl] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in lactate dehydrogenase [U/L] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in CPK-MB [ng/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in troponin [ng/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in von Willebrand factor antigen level (VWF:Ag) [%] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in von Willebrand factor activity (ristocetin cofactor) [%] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in ADAMTS-13 [%] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in von Willebrand multimeters from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in plasminogen activator inhibitor-1 levels [ng/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Janus Kinase Inhibitor (ruxolitinib) in people with Severe Acute Respiratory Syndrome Coronavirus 2 and SARS-CoV2, run by Vanderson Geraldo Rocha at 1 site in Brazil.
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 2 inclusion and 16 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 8 Apr 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low accrual). 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?
A composite outcome of death or ICU admission or mechanical ventilation at day 14. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2021.