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.
Drug: Ruxolitinib Oral Tablet
Ruxolitinib Oral Tablet dosage of at least 20 mg x 2 / day in the first 48 hours
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.
Enrico Dr Capochiani, hematologist
00393473527340
enrico.capochiani@uslnordovest.toscana.it
Barbara Dr Meini, Pharmacist
00390586223031
barbara.meini@uslnordovest.toscana.it
Enrico Dr Capochiani, hematologist, Principal Investigator
Azienda USL Toscana Nord Ovest