Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ruxolitinib for the Treatment of Acute Respiratory Distress Syndrome in Patients With COVID-19 Infection (RESPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04361903
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborators:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Azienda Ospedaliera Universitaria Senese
Azienda Ospedaliero, Universitaria Pisana
Information provided by (Responsible Party):
Enrico Capochiani, Azienda USL Toscana Nord Ovest

Brief 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.

Condition or disease Intervention/treatment
Severe Acute Respiratory Syndrome Coronavirus 2 Drug: Ruxolitinib Oral Tablet

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: COVID-19: Ruxolitinib for the Treatment of cytokinE Storm resPiratory dIstREss Syndrome. RESPIRE Study
Estimated Study Start Date : April 25, 2020
Estimated Primary Completion Date : May 24, 2020
Estimated Study Completion Date : May 31, 2020


Group/Cohort Intervention/treatment
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.
Drug: Ruxolitinib Oral Tablet
Ruxolitinib Oral Tablet dosage of at least 20 mg x 2 / day in the first 48 hours




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Improvement of respiratory performance - Arterial Blood Gas Analisys - pH [ Time Frame: 15 days ]
    ABG (arterial Blood Gas): pH as SI Unit, every 12 hours and in any case in the presence of significant clinical variations.

  2. Improvement of respiratory performance - Arterial Blood Gas Analisys - pO2 [ Time Frame: 15 days ]
    ABG (arterial Blood Gas): pO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.

  3. Improvement of respiratory performance - Arterial Blood Gas Analisys - pCO2 [ Time Frame: 15 days ]
    ABG (arterial Blood Gas): pCO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.

  4. Improvement of respiratory performance - ratio values [ Time Frame: 15 days ]
    PaO2 / FiO2, SatO2 ratio. Vital parameters and respiratory function every 12 hours and in any case in the presence of significant clinical variations.

  5. Evaluation of known adverse events related to the use of the drug - D-Dimer [ Time Frame: 15 days ]
    every 24 hours D-Dimer value in mgr/ml

  6. Evaluation of known adverse events related to the use of the drug - fibrinogen [ Time Frame: 15 days ]
    every 24 hours fibrinogen value in mg/dl

  7. Evaluation of known adverse events related to the use of the drug - transaminases [ Time Frame: 15 days ]
    every 24 hours transaminases value in U/L

  8. Evaluation of known adverse events related to the use of the drug - aPTT [ Time Frame: 15 days ]
    every 24 hours aPTT value in seconds

  9. Evaluation of known adverse events related to the use of the drug - INR [ Time Frame: 15 days ]
    every 24 hours INR value in %

  10. Evaluation of known adverse events related to the use of the drug - glycemia [ Time Frame: 15 days ]
    every 24 hours glycemia value in mg/dl

  11. Evaluation of known adverse events related to the use of the drug - creatinine [ Time Frame: 15 days ]
    every 24 hours creatinine serum value in mg/dl

  12. Evaluation of known adverse events related to the use of the drug - Leucocytes count [ Time Frame: 15 days ]
    Total leucocyte as CBC x10e)/L

  13. Evaluation of known adverse events related to the use of the drug - Leucocytes formula [ Time Frame: 15 days ]
    formula % on total leucocyte

  14. Evaluation of the epidemiological parameters: Chest CT [ Time Frame: 15 days ]
    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.

  15. Evaluation of the epidemiological parameters: Eco Chest [ Time Frame: 15 days ]
    Thoracic imaging: every day: presence and number of line B every 48 hours.Time elapsed between the onset of clinical symptoms and hospitalization.

  16. Evaluation of the epidemiological parameters: CHEST X-ray [ Time Frame: 15 days ]
    Thoracic imaging: presence, extension and dimension on lung thickening - Chest X-ray, Time elapsed between the onset of clinical symptoms and hospitalization.

  17. Monitoring of Serum levels of cytokines before and every 48 h from start to to end of treatment [ Time Frame: 15 days ]
    Monitoring of serum cytokines (IL-6 in pgr/dL, TNF in pgr/dL) every 48 h

  18. Monitoring incidence of treatment Emergent Adverse Events of ruxolitinib therapy [ Time Frame: 15 days ]
    Number of AE grade 1 to 4



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361903


Contacts
Layout table for location contacts
Contact: Enrico Dr Capochiani, hematologist 00393473527340 enrico.capochiani@uslnordovest.toscana.it
Contact: Barbara Dr Meini, Pharmacist 00390586223031 barbara.meini@uslnordovest.toscana.it

Sponsors and Collaborators
Azienda USL Toscana Nord Ovest
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Azienda Ospedaliera Universitaria Senese
Azienda Ospedaliero, Universitaria Pisana
Investigators
Layout table for investigator information
Principal Investigator: Enrico Dr Capochiani, hematologist Azienda USL Toscana Nord Ovest
Layout table for additonal information
Responsible Party: Enrico Capochiani, MD Hematologist, Azienda USL Toscana Nord Ovest
ClinicalTrials.gov Identifier: NCT04361903    
Other Study ID Numbers: 2020.COVID-19.RUXO106
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enrico Capochiani, Azienda USL Toscana Nord Ovest:
Ruxolitinib
Acute Respiratory Distress Syndrome
COVID-19
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections