TOFAcitinib in Patients With Early Onset SARS-CoV2 Interstitial Pneumonia
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- need of mechanical ventilation
研究概览
简要总结
Immune-mediated lung injury plays a pivotal role in severe interstitial pnemumonia related to SARS-CoV2 infection. Tofacitinib, a JAK1/3-Inhibitor, could mitigate alveolar inflammation by blocking IL-6 signal. The aim of this prospective single cohort open study is to test the hypotesis that early administration of tofacitinib in patients with symptomatic pneumonia could reduce pulmonary flogosis, preventing function deterioration and the need of mechanical ventilation and/or admission in intensive care units.
详细描述
Interstitial Pneumonia is the main complication of SARS-CoV2 infection. Immune system hyperactivation, leading to alveolar inflammation, is the main mechanism in determining lung damage. Evidence are accumulating about the pivotal role played by IL-6 in this disease. Preliminary evidence, indeed, point out the efficacy of an IL-6 receptor inhibitor in improving clinical conditions in a proportion of rapidly deteriorating patients. Our hypotesis is that a precocious inhibition of IL-6 signal, by the administration of tofacitinib (JAK 1/3 Inhibitor), could hinder the progression to more severe grades of lung inflammation leading to pulmonary function deterioration. In a prospective single cohort open study, 50 patients admitted in Hospital due to SARS-CoV 2 symptomatic interstitial pneumonia, but not requiring mechanical ventilation, will be enrolled. Tofacitinb will be administered every day for 14 days, starting within 24 h from the admission. The primary outcome is to evaluate the effect of this drug on the rate of patients who will need mechanical ventilation. Safety in this population will also be actively monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SARS-CoV2 Infection diagnosed by rt-PCR
- •Rx or CT-scan confirmed interstitial pneumonia
- •Hospital admission from less than 24h
- •Written Informed Consent
排除标准
- •Age <18 ys or >65
- •Patients in mechanical ventilation at time of admission
- •Severe Hearth failure (NYHA 3 or 4)
- •Severe History of Chronic Ischemic Hearth Disease, defined as history of Major Adverse Cardiovascular Event and/or recent (one year) revascularization.
- •History of recurrent Deep Venous Thrombosis and Pulmonary Embolism
- •Active Bacterial or Fungal Infection
- •Hematological cancer
- •Metastatic or intractable cancer
- •Pre-existent neurodegenerative disease
- •Severe Hepatic Impairment
- •Severe Renal Failure (Creatinine Clearance <30ml/h)
- •Active Herpes zoster infection
- •Severe anemia (Hb<9g/dl)
- •Lymphocyte count below 750/mcl
- •Neutrophil count below 1000/mcl
- •Platelet count below 50000/mcl
- •Pregnancy or Lactation
- •Inability to give informed consent (severe transitory or permanent mental impairment, incapacitation)
研究组 & 干预措施
tofacitinib
Tofacitinib cp 5mg: 2pills twice a day for 14 days
干预措施: Tofacitinib (Drug)
结局指标
主要结局
need of mechanical ventilation
时间窗: day 14
Rate of patients needing mechanical ventilation to maintain PaO2/FIO2\>150 or, if PaO2 data not available, to maintain SO2\>94% with FiO2 0,5.
次要结局
- death(day 28)
- rate of adverse events(day 28)
- need of admission in intensive care unit(day 14)
研究者
Armando Gabrielli
Full Professor Internal Medicine
Università Politecnica delle Marche