Ruxolitinib for the Treatment of Acute Respiratory Distress Syndrome in Patients With COVID-19 Infection
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2
- Interventions
- Registration Number
- NCT04361903
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 13
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients treated with ruxolutinib Ruxolitinib Oral Tablet 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.
- Primary Outcome Measures
Name Time Method Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 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
Name Time Method Improvement of respiratory performance - Arterial Blood Gas Analisys - pCO2 15 days ABG (arterial Blood Gas): pCO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.
Improvement of respiratory performance - ratio values 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.
Improvement of respiratory performance - Arterial Blood Gas Analisys - pH 15 days ABG (arterial Blood Gas): pH as SI Unit, every 12 hours and in any case in the presence of significant clinical variations.
Improvement of respiratory performance - Arterial Blood Gas Analisys - pO2 15 days ABG (arterial Blood Gas): pO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.
Evaluation of known adverse events related to the use of the drug - D-Dimer 15 days every 24 hours D-Dimer value in mgr/ml
Evaluation of known adverse events related to the use of the drug - fibrinogen 15 days every 24 hours fibrinogen value in mg/dl
Evaluation of known adverse events related to the use of the drug - transaminases 15 days every 24 hours transaminases value in U/L
Evaluation of known adverse events related to the use of the drug - aPTT 15 days every 24 hours aPTT value in seconds
Evaluation of known adverse events related to the use of the drug - INR 15 days every 24 hours INR value in %
Evaluation of known adverse events related to the use of the drug - glycemia 15 days every 24 hours glycemia value in mg/dl
Evaluation of known adverse events related to the use of the drug - creatinine 15 days every 24 hours creatinine serum value in mg/dl
Evaluation of known adverse events related to the use of the drug - Leucocytes count 15 days Total leucocyte as CBC x10e)/L
Evaluation of known adverse events related to the use of the drug - Leucocytes formula 15 days formula % on total leucocyte
Evaluation of the epidemiological parameters: Chest CT 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.
Evaluation of the epidemiological parameters: Eco Chest 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.
Evaluation of the epidemiological parameters: CHEST X-ray 15 days Thoracic imaging: presence, extension and dimension on lung thickening - Chest X-ray, Time elapsed between the onset of clinical symptoms and hospitalization.
Monitoring of Serum levels of cytokines before and every 48 h from start to to end of treatment 15 days Monitoring of serum cytokines (IL-6 in pgr/dL, TNF in pgr/dL) every 48 h
Monitoring incidence of treatment Emergent Adverse Events of ruxolitinib therapy 15 days Number of AE grade 1 to 4