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临床试验/NCT05157204
NCT05157204Unknown不适用

Measurment of Interleuukin-6 at Exhaled Breath of Condensate of Covid-19 Patients and Post Covid-19 Patients With Lung Fibrosis Randomized Controlled Study

Ministry of Health, Saudi Arabia0 个研究点目标入组 60 人开始时间: 2022年1月26日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
measurement of interleukin-6 at exhaled condensate in covid-19, postcovid-19 ,healthy subjects

研究概览

简要总结

COVID-19 has emerged as a global pandemic. It is mainly manifested as pneumonia which may deteriorate into severe respiratory failure. The major hallmark of the disease is the systemic inflammatory immune response characterized by Cytokine Storm (CS). CS is marked by elevated levels of inflammatory cytokines, mainly interleukin-6 (IL-6), IL-8, IL-10, tumour necrosis factor-α (TNF-α) and interferon-γ (IFN-γ). Of these, IL-6 is found to be significantly associated with higher mortality. IL-6 is also a robust marker for predicting disease prognosis and deterioration of clinical profile. (1) IL-6 was detectable in the breath condensate of all the healthy non-smokers, but was significantly higher in the COPD patient. Exhaled breath condensate is totally non-invasive and highly acceptable to patients. The collection procedure has no effect on airway function or inflammation, and there is growing evidence that abnormalities in condensate composition may reflect biochemical changes in airway lining fluid. This method has been successfully used in previous studies to investigate several inflammatory markers in COPD and asthmatic patients. (2) Il-6 is produced in the lung by interstitial fibroblasts, alveolar macrophages, and large-vessel and bronchial epithelial cells. IL-6 levels are high in chronic inflammatory conditions of the lung, such as those due to allogeneic transplantation, bleomycin-induced fibrosis and a variety of human interstitial lung diseases. High levels of IL-6 have been found in the induced sputum of patients with COPD, particularly during exacerbation. Park et al. found increased IL-6 levels in the Bronchioalveolar lavage fluid of patients with non-specific interstitial pneumonia/fibrosis and in some patients with interstitial pneumonia. (3) the study involved 20 healthy controls and 20 patients with moderate to severe covid-19 according to cdc classifaction and 20 patients post covid-19 with lung fibrosis to estimate the measurment of interleukin-6 at exhaled condensate, this clinical randomized control study consists of 3 arms for 6 month ( all participants above 18 years non prgnant humans )

详细描述

COVID-19 has emerged as a global pandemic. It is mainly manifested as pneumonia which may deteriorate into severe respiratory failure. The major hallmark of the disease is the systemic inflammatory immune response characterized by Cytokine Storm (CS). CS is marked by elevated levels of inflammatory cytokines, mainly interleukin-6 (IL-6), IL-8, IL-10, tumour necrosis factor-α (TNF-α) and interferon-γ (IFN-γ). Of these, IL-6 is found to be significantly associated with higher mortality. IL-6 is also a robust marker for predicting disease prognosis and deterioration of clinical profile. (1) IL-6 was detectable in the breath condensate of all the healthy non-smokers, but was significantly higher in the COPD patient. Exhaled breath condensate is totally non-invasive and highly acceptable to patients. The collection procedure has no effect on airway function or inflammation, and there is growing evidence that abnormalities in condensate composition may reflect biochemical changes in airway lining fluid. This method has been successfully used in previous studies to investigate several inflammatory markers in COPD and asthmatic patients. (2) Il-6 is produced in the lung by interstitial fibroblasts, alveolar macrophages, and large-vessel and bronchial epithelial cells. IL-6 levels are high in chronic inflammatory conditions of the lung, such as those due to allogeneic transplantation, bleomycin-induced fibrosis and a variety of human interstitial lung diseases. High levels of IL-6 have been found in the induced sputum of patients with COPD, particularly during exacerbation. Park et al. found increased IL-6 levels in the Bronchioalveolar lavage fluid of patients with non-specific interstitial pneumonia/fibrosis and in some patients with interstitial pneumonia. (3) Dowlati et al. have reported increased levels of IL-6 in the serum and BAL fluid of patients with lung cancer. (4) A recent study by Bhowmik et al. found increased IL-6 and IL-8 levels in the sputum of COPD patients with frequent exacerbations. (5) Also, at another study Exhaled interleukin-6 and leukotriene B4 levels may be useful noninvasive markers of airway inflammation in cigarette smokers. (6) These studies and our novel method after clinical trials may open the field for future therapies for covid-19 and post covid-19 lung fibrosis by inhaler transport medicines as a new challenge for overcome sequels of this pandemic. And this suggested new procedure for measurement of exhaled il-6 take us to study which is IL-6 is risky is IL-6 produced from airway or endocrine IL-6 or immune IL-6 From previous studies we need a procedure acceptable to patients and easy, noninvasive, sensitive he study involved 20 healthy controls and 20 patients with moderate to severe covid-19 according to cdc classifaction and 20 patients post covid-19 with lung fibrosis to estimate the measurment of interleukin-6 at exhaled condensate, this clinical randomized control study consists of 3 arms for 6 month ( all participants above 18 years non prgnant humans )

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age above 18 years
  • covid-19 patients (20) with real time PCR positive test moderate to severe according to CDC classification
  • smokers are included
  • post-covid 19 patients with real-time pcr positive test
  • 20 healthy subjects

排除标准

  • below 18 years and above 80 years pregnant womens any medications as anti-il-6 unstable cases history of copd cases or lung disease or lung cancer

结局指标

主要结局

measurement of interleukin-6 at exhaled condensate in covid-19, postcovid-19 ,healthy subjects

时间窗: 6 month

次要结局

未报告次要终点

研究者

发起方
Ministry of Health, Saudi Arabia
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Amr kamel khalil Ahmed

Saudia Arabia , Riyadh . public health , First health cluster

Ministry of Health, Saudi Arabia

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