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临床试验/NCT05137509
NCT05137509尚未招募不适用

YKL -40 as Anew Biomarker in COVID -19 Patients

Assiut University0 个研究点目标入组 100 人开始时间: 2022年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Using YKL -40 to help in diagnosis of COVID -19 and assessment of disease severity

研究概览

简要总结

The coronavirus disease-2019 (COVID-19)is a pandemic disease caused by SARS -COV-2 which belongs to the β-coronavirus family . The majority of affected individuals exhibit no or mild to moderate symptoms, but up to 15% of patients develop severe pneumonia with approximately 6% progressing to acute respiratory distress syndrome and multiorgan failure.

Biomarkers are needed to identify patients will suffer rapid disease progression to severe complications and death. Preliminary studies describe vasculitic processes underlying organ damage in seriously ill patients, induced by the activation of inflammatory cascades, complement activation and pro-inflammatory cytokines (i.e. interleukin).

The severity of Vasculitic damage is unfortunately not easily predictable through currently used laboratory biomarkers such as D-dimer or prothrombin time/activated partial thromboplastin time.

The severity of the disease is mainly driven by diffuse interstitial lung diseases. YKL-40 has a pro mitogenic action on pulmonary fibroblasts, increases the activity of macrophages and is associated with inflammatory disorders. In ILD, YKL-40 has been described to be associated with the severity of lung diseases and with the risk of death.

YKL-40 serum levels could therefore be of interest for diagnosis and prognosis since it is at the cross-link between vascular and epithelial lung damage.

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研究设计

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

入排标准

年龄范围
— 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •• Group one should be diagnosed by RT-PCR (reverse transcriptase polymerase chain reaction).
  • •Healthy individual must be without a prior history of chronic inflammation in the lung.

排除标准

  • •Patients with acute renal failure (ARF) or multiple organ damage (MOF).

结局指标

主要结局

Using YKL -40 to help in diagnosis of COVID -19 and assessment of disease severity

时间窗: 2 years

* 1- To highlight the role of YKL-40 biomarker in diagnosis of COVID -19 and assessment of disease severity. * 2- To compare the sensitivity and the specificity of YKL- 40 in relation to other biomarkers used in diagnosis of Covid-19.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Norhan mostafa Mohamed Abdelal

principle investigator

Assiut University

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