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

Azienda USL Toscana Nord Ovest

Status: Unknown

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2

Treatments: Drug: Ruxolitinib Oral Tablet

Study type: Observational

Funder types: Other

Identifiers

NCT04361903

2020.COVID-19.RUXO106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

13 participants in 1 patient group

Patients treated with ruxolutinib

Description:

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.

Treatment:

Drug: Ruxolitinib Oral Tablet