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

N/AUnknownNCT04361903

Azienda USL Toscana Nord Ovest13 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Interventions

Ruxolitinib Oral TabletDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 15 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 15 days

Evaluation of known adverse events related to the use of the drug - fibrinogen

Central Contacts

Enrico Dr Capochiani, hematologist

CONTACT

00393473527340 enrico.capochiani@uslnordovest.toscana.it

Barbara Dr Meini, Pharmacist

CONTACT

00390586223031 barbara.meini@uslnordovest.toscana.it

Data from ClinicalTrials.gov

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