Severe Acute Respiratory Syndrome Coronavirus 2RESPIRENCT04361903
Ruxolitinib for the Treatment of Acute Respiratory Distress Syndrome in Patients With COVID-19 Infection
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2, run by Azienda USL Toscana Nord Ovest.
Trial summary
It is an observational, cohort, retrospective, monocentric, non-profit study. The primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2
- What is being tested?
- Ruxolitinib Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2020to 31 May 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with SARS-CoV-2 COVID-19 pneumonia who started off-label ruxolitinib treatment in the period between 03/24/2020 and 07/04/2020, with a dosage of at least 20 mg x 2 / day in the first 48 hours
Who may be able to join
- positive analysis for RT PCR (Shanghai BioTec or Sansure Biotech) for SARS-CoV-2 in a respiratory tract sample;
- Imaging (CT / ECO / RX) positive for pneumonia;
- Oxygen saturation (SaO2) of 93% or less in the environment;
- Partial oxygen pressure ratio (PaO2) on inspired oxygen fraction (FiO2) (PaO2 / FiO2) lower than 250 mg / Hg, but not lower than 100 mg / Hg;
- Rapid clinical evolution with worsening of respiratory parameters in the last 12 hours.
- Release of informed consent.
Who cannot join
- Pregnancy and breastfeeding;
- Patients already in assisted breathing with tracheal cannula;
- Patients with active and uncompensated serious pathologies previously to the COVID 19 infection;
- Known hypersensitivity to ruxolitinib or to any of the excipients listed in section 6.1 of the SPC;
- Patients with renal insufficiency;
- Patients with positive quantiferon;
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- Patients with documented uncontrolled bacterial sepsis (excluding procalcitonin increase in the presence of negative blood cultures);
- Patients with neutropenia equal to or less than 1000 PMN / mmc;
- Patients with thrombocytopenia equal to or less than 100000 / mmc.
- HCV and / or HBV positive patients, HIV.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: COVID-19: Ruxolitinib for the Treatment of cytokinE Storm resPiratory dIstREss Syndrome. RESPIRE Study
It is an observational, cohort, retrospective, monocentric, non-profit study. The primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.
Read the detailed description
It is an observational, cohort, retrospective, monocentric, non-profit study. Patients with SARS-CoV-2 COVID-19 pneumonia who started off-label Ruxolitinib treatment in the period between 25/03/2020 and 07/04/2020 in hospitalization in the COVID-19 wards of the USL Toscana Nord Ovest company.
Primary objective
- Evaluation of the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.
Secondary objectives
- Improvement of respiratory performance.
- Improvement of acute phase inflammation indices.
- Evaluation of known adverse events related to the use of the drug.
- Evaluation of the epidemiological parameters in COVID-19 patients.
- Monitoring of plasma levels of cytokines before and after treatment. Exploratory objectives
- Analysis of the outcomes for the launch of a study on the efficacy and safety of Ruxolitinib in the treatment of ADRS in COVID-19 patients.
- Being tested
- Ruxolitinib Oral Tablet
- Keywords
- Ruxolitinib, Acute Respiratory Distress Syndrome, COVID-19
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib Oral TabletDrug
Ruxolitinib Oral Tablet dosage of at least 20 mg x 2 / day in the first 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with ruxolutinib | SARS-CoV-2 COVID-19 patients with rapid worsening of respiratory parameters in the last 12 hours treated with ruxolutinib, dosage of at least 20 mg x 2 / day in the first 48 hours. Receives: Drug: Ruxolitinib Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19
Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours
Measured: 15 days
Secondary outcomes (18)
Improvement of respiratory performance - Arterial Blood Gas Analisys - pH
ABG (arterial Blood Gas): pH as SI Unit, every 12 hours and in any case in the presence of significant clinical variations.
Measured: 15 days
Improvement of respiratory performance - Arterial Blood Gas Analisys - pO2
ABG (arterial Blood Gas): pO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.
Measured: 15 days
Improvement of respiratory performance - Arterial Blood Gas Analisys - pCO2
ABG (arterial Blood Gas): pCO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.
Measured: 15 days
Improvement of respiratory performance - ratio values
PaO2 / FiO2, SatO2 ratio. Vital parameters and respiratory function every 12 hours and in any case in the presence of significant clinical variations.
Measured: 15 days
Evaluation of known adverse events related to the use of the drug - D-Dimer
every 24 hours D-Dimer value in mgr/ml
Measured: 15 days
Evaluation of known adverse events related to the use of the drug - fibrinogen
every 24 hours fibrinogen value in mg/dl
Measured: 15 days
Evaluation of known adverse events related to the use of the drug - transaminases
every 24 hours transaminases value in U/L
Measured: 15 days
Evaluation of known adverse events related to the use of the drug - aPTT
every 24 hours aPTT value in seconds
Measured: 15 days
Evaluation of known adverse events related to the use of the drug - INR
every 24 hours INR value in %
Measured: 15 days
Evaluation of known adverse events related to the use of the drug - glycemia
every 24 hours glycemia value in mg/dl
Measured: 15 days
Evaluation of known adverse events related to the use of the drug - creatinine
every 24 hours creatinine serum value in mg/dl
Measured: 15 days
Evaluation of known adverse events related to the use of the drug - Leucocytes count
Total leucocyte as CBC x10e)/L
Measured: 15 days
Evaluation of known adverse events related to the use of the drug - Leucocytes formula
formula % on total leucocyte
Measured: 15 days
Evaluation of the epidemiological parameters: Chest CT
Thoracic imaging, every 48 h: presence, extension and dimension on lung thickening - Chest CT at start and end of treatment, Time elapsed between the onset of clinical symptoms and hospitalization.
Measured: 15 days
Evaluation of the epidemiological parameters: Eco Chest
Thoracic imaging: every day: presence and number of line B every 48 hours.Time elapsed between the onset of clinical symptoms and hospitalization.
Measured: 15 days
Evaluation of the epidemiological parameters: CHEST X-ray
Thoracic imaging: presence, extension and dimension on lung thickening - Chest X-ray, Time elapsed between the onset of clinical symptoms and hospitalization.
Measured: 15 days
Monitoring of Serum levels of cytokines before and every 48 h from start to to end of treatment
Monitoring of serum cytokines (IL-6 in pgr/dL, TNF in pgr/dL) every 48 h
Measured: 15 days
Monitoring incidence of treatment Emergent Adverse Events of ruxolitinib therapy
Number of AE grade 1 to 4
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start25 Apr 2020 (estimated)
- Primary completion24 May 2020 (estimated)
- Study completion31 May 2020 (estimated)
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Toscana Nord Ovest
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Azienda Ospedaliera Universitaria Senese, Azienda Ospedaliero, Universitaria Pisana
- Responsible party
- Principal investigator, Enrico Capochiani, Azienda USL Toscana Nord Ovest
- Investigators
- Enrico Dr Capochiani, hematologist, Principal investigator, Azienda USL Toscana Nord Ovest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361903
- Sponsor's protocol ID
- 2020.COVID-19.RUXO106
- Acronym
- RESPIRE
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Capochiani E, Frediani B, Iervasi G, Paolicchi A, Sani S, Roncucci P, Cuccaro A, Franchi F, Simonetti F, Carrara D, Bertaggia I, Nasso D, Riccioni R, Scolletta S, Valente S, Conticini E, Gozzetti A, Bocchia M. Ruxolitinib Rapidly Reduces Acute Respiratory Distress Syndrome in COVID-19 Disease. Analysis of Data Collection From RESPIRE Protocol. Front Med (Lausanne). 2020 Aug 4;7:466. doi: 10.3389/fmed.2020.00466. eCollection 2020.
PubMed 32850921
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: Ruxolitinib for the Treatment of cytokinE Storm resPiratory dIstREss Syndrome. RESPIRE Study
- ClinicalTrials.gov ID
- NCT04361903
- Acronym / sponsor ID
- RESPIRE / 2020.COVID-19.RUXO106
- Keywords
- Ruxolitinib, Acute Respiratory Distress Syndrome, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Azienda USL Toscana Nord OvestUniversity, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Azienda Ospedaliera Universitaria Senese, Azienda Ospedaliero, Universitaria Pisana
- Study start
- 25 Apr 2020 (estimated)
- Primary completion
- 24 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 24 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.
It is an observational, cohort, retrospective, monocentric, non-profit study. The primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.
Detailed description
It is an observational, cohort, retrospective, monocentric, non-profit study. Patients with SARS-CoV-2 COVID-19 pneumonia who started off-label Ruxolitinib treatment in the period between 25/03/2020 and 07/04/2020 in hospitalization in the COVID-19 wards of the USL Toscana Nord Ovest company.
Primary objective
- Evaluation of the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.
Secondary objectives
- Improvement of respiratory performance.
- Improvement of acute phase inflammation indices.
- Evaluation of known adverse events related to the use of the drug.
- Evaluation of the epidemiological parameters in COVID-19 patients.
- Monitoring of plasma levels of cytokines before and after treatment. Exploratory objectives
- Analysis of the outcomes for the launch of a study on the efficacy and safety of Ruxolitinib in the treatment of ADRS in COVID-19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with ruxolutinib | – | Drug: Ruxolitinib Oral TabletSARS-CoV-2 COVID-19 patients with rapid worsening of respiratory parameters in the last 12 hours treated with ruxolutinib, dosage of at least 20 mg x 2 / day in the first 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with SARS-CoV-2 COVID-19 pneumonia who started off-label ruxolitinib treatment in the period between 03/24/2020 and 07/04/2020, with a dosage of at least 20 mg x 2 / day in the first 48 hours
Key inclusion criteria (6 listed)
- positive analysis for RT PCR (Shanghai BioTec or Sansure Biotech) for SARS-CoV-2 in a respiratory tract sample;
- Imaging (CT / ECO / RX) positive for pneumonia;
- Oxygen saturation (SaO2) of 93% or less in the environment;
- Partial oxygen pressure ratio (PaO2) on inspired oxygen fraction (FiO2) (PaO2 / FiO2) lower than 250 mg / Hg, but not lower than 100 mg / Hg;
- Rapid clinical evolution with worsening of respiratory parameters in the last 12 hours.
Key exclusion criteria (10 listed)
- Pregnancy and breastfeeding;
- Patients already in assisted breathing with tracheal cannula;
- Patients with active and uncompensated serious pathologies previously to the COVID 19 infection;
- Known hypersensitivity to ruxolitinib or to any of the excipients listed in section 6.1 of the SPC;
- Patients with renal insufficiency;
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 |
|---|---|---|
| Ruxolitinib Oral TabletRuxolitinib Oral Tablet dosage of at least 20 mg x 2 / day in the first 48 hours | Drug | Patients treated with ruxolutinib |
Primary outcome
Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19
Time frame: 15 days
Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours
18 secondary outcomes
Improvement of respiratory performance - Arterial Blood Gas Analisys - pH
Time frame: 15 days
Improvement of respiratory performance - Arterial Blood Gas Analisys - pO2
Time frame: 15 days
Improvement of respiratory performance - Arterial Blood Gas Analisys - pCO2
Time frame: 15 days
Improvement of respiratory performance - ratio values
Time frame: 15 days
Evaluation of known adverse events related to the use of the drug - D-Dimer
Time frame: 15 days
Evaluation of known adverse events related to the use of the drug - fibrinogen
Time frame: 15 days
Evaluation of known adverse events related to the use of the drug - transaminases
Time frame: 15 days
Evaluation of known adverse events related to the use of the drug - aPTT
Time frame: 15 days
Evaluation of known adverse events related to the use of the drug - INR
Time frame: 15 days
Evaluation of known adverse events related to the use of the drug - glycemia
Time frame: 15 days
Evaluation of known adverse events related to the use of the drug - creatinine
Time frame: 15 days
Evaluation of known adverse events related to the use of the drug - Leucocytes count
Time frame: 15 days
Evaluation of known adverse events related to the use of the drug - Leucocytes formula
Time frame: 15 days
Evaluation of the epidemiological parameters: Chest CT
Time frame: 15 days
Evaluation of the epidemiological parameters: Eco Chest
Time frame: 15 days
Evaluation of the epidemiological parameters: CHEST X-ray
Time frame: 15 days
Monitoring of Serum levels of cytokines before and every 48 h from start to to end of treatment
Time frame: 15 days
Monitoring incidence of treatment Emergent Adverse Events of ruxolitinib therapy
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 32850921Capochiani E, Frediani B, Iervasi G, Paolicchi A, Sani S, Roncucci P, Cuccaro A, Franchi F, Simonetti F, Carrara D, Bertaggia I, Nasso D, Riccioni R, Scolletta S, Valente S, Conticini E, Gozzetti A, Bocchia M. Ruxolitinib Rapidly Reduces Acute Respiratory Distress Syndrome in COVID-19 Disease. Analysis of Data Collection From RESPIRE Protocol. Front Med (Lausanne). 2020 Aug 4;7:466. doi: 10.3389/fmed.2020.00466. eCollection 2020.
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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.
Enrico Dr Capochiani, hematologist principal investigator
Azienda USL Toscana Nord Ovest
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2, run by Azienda USL Toscana Nord Ovest.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrico Dr Capochiani, hematologist (00393473527340, enrico.capochiani@uslnordovest.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 (time frame: 15 days). 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 NCT04361903, 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 24 Apr 2020.