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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04361903
Other study ID # 2020.COVID-19.RUXO106
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 25, 2020
Est. completion date May 31, 2020

Study information

Verified date April 2020
Source Azienda USL Toscana Nord Ovest
Contact Enrico Dr Capochiani, hematologist
Phone 00393473527340
Email enrico.capochiani@uslnordovest.toscana.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 13
Est. completion date May 31, 2020
Est. primary completion date May 24, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Coronavirus Infections
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Severe Acute Respiratory Syndrome
  • Severe Acute Respiratory Syndrome Coronavirus 2
  • Syndrome

Intervention

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

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Azienda USL Toscana Nord Ovest Azienda Ospedaliera Universitaria Senese, Azienda Ospedaliero, Universitaria Pisana, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Outcome

Type Measure Description Time frame Safety issue
Primary 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 15 days
Secondary 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. 15 days
Secondary 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. 15 days
Secondary 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. 15 days
Secondary 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. 15 days
Secondary Evaluation of known adverse events related to the use of the drug - D-Dimer every 24 hours D-Dimer value in mgr/ml 15 days
Secondary Evaluation of known adverse events related to the use of the drug - fibrinogen every 24 hours fibrinogen value in mg/dl 15 days
Secondary Evaluation of known adverse events related to the use of the drug - transaminases every 24 hours transaminases value in U/L 15 days
Secondary Evaluation of known adverse events related to the use of the drug - aPTT every 24 hours aPTT value in seconds 15 days
Secondary Evaluation of known adverse events related to the use of the drug - INR every 24 hours INR value in % 15 days
Secondary Evaluation of known adverse events related to the use of the drug - glycemia every 24 hours glycemia value in mg/dl 15 days
Secondary Evaluation of known adverse events related to the use of the drug - creatinine every 24 hours creatinine serum value in mg/dl 15 days
Secondary Evaluation of known adverse events related to the use of the drug - Leucocytes count Total leucocyte as CBC x10e)/L 15 days
Secondary Evaluation of known adverse events related to the use of the drug - Leucocytes formula formula % on total leucocyte 15 days
Secondary 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. 15 days
Secondary 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. 15 days
Secondary 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. 15 days
Secondary 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 15 days
Secondary Monitoring incidence of treatment Emergent Adverse Events of ruxolitinib therapy Number of AE grade 1 to 4 15 days
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