Status:
UNKNOWN
Ruxolitinib for the Treatment of Acute Respiratory Distress Syndrome in Patients With COVID-19 Infection
Lead Sponsor:
Azienda USL Toscana Nord Ovest
Collaborating Sponsors:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Azienda Ospedaliera Universitaria Senese
Conditions:
Severe Acute Respiratory Syndrome Coronavirus 2
Eligibility:
All Genders
18+ years
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 pati...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04361903
Start Date
April 25 2020
End Date
May 31 2020
Last Update
April 24 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.