COVID-19: Ruxolitinib for the Treatment of cytokinE Storm resPiratory dIstREss Syndrome. RESPIRE Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 13
- 主要终点
- Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients treated with ruxolutinib
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.
干预措施: Ruxolitinib Oral Tablet (Drug)
结局指标
主要结局
Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19
时间窗: 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
次要结局
- Improvement of respiratory performance - Arterial Blood Gas Analisys - pCO2(15 days)
- Improvement of respiratory performance - ratio values(15 days)
- Improvement of respiratory performance - Arterial Blood Gas Analisys - pH(15 days)
- Improvement of respiratory performance - Arterial Blood Gas Analisys - pO2(15 days)
- Evaluation of known adverse events related to the use of the drug - D-Dimer(15 days)
- Evaluation of known adverse events related to the use of the drug - fibrinogen(15 days)
- Evaluation of known adverse events related to the use of the drug - transaminases(15 days)
- Evaluation of known adverse events related to the use of the drug - aPTT(15 days)
- Evaluation of known adverse events related to the use of the drug - INR(15 days)
- Evaluation of known adverse events related to the use of the drug - glycemia(15 days)
- Evaluation of known adverse events related to the use of the drug - creatinine(15 days)
- Evaluation of the epidemiological parameters: Chest CT(15 days)
- Evaluation of known adverse events related to the use of the drug - Leucocytes count(15 days)
- Evaluation of known adverse events related to the use of the drug - Leucocytes formula(15 days)
- Evaluation of the epidemiological parameters: Eco Chest(15 days)
- Evaluation of the epidemiological parameters: CHEST X-ray(15 days)
- Monitoring of Serum levels of cytokines before and every 48 h from start to to end of treatment(15 days)
- Monitoring incidence of treatment Emergent Adverse Events of ruxolitinib therapy(15 days)
研究者
Enrico Capochiani
MD Hematologist
Azienda USL Toscana Nord Ovest