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临床试验/NCT04784468
NCT04784468Unknown不适用

DNA Damage and Oxidative Stress in Hospitalized COVID-19 Patients Compared to Healthy Controls: A Case-control Study

University of Vienna1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2020年11月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
135
试验地点
1
主要终点
DNA damage

研究概览

简要总结

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the coronavirus disease 2019 (COVID-19) pandemic challenging health systems worldwide.

While there is a clear correlation between oxidative stress markers and the severity of many viral diseases such as hepatitis C, for SARS-CoV clinical data is limited.

The investigators aim at 1.) investigating DNA damage, oxidative stress, inflammation, and aging markers in COVID-19 patients and compare them with age and gender matched healthy controls and patients with influenza; and 2.) investigating all aforementioned parameters during "cytokine storm" via repeated blood sampling.

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • gender: female/male
  • age: ≥40 years
  • patients admitted at the emergency department
  • COVID-19 suspected patients
  • able to give written informed consent

排除标准

  • children (≤ 18 years) and adults 19-39 years
  • not hospitalized, but confirmed COVID-19 patients (outpatients)
  • patients without definitive COVID-19 confirmation
  • Control group:
  • Inclusion criteria:
  • gender: female/male
  • age: ≥40 years
  • absence of severe illnesses/serious diseases
  • able to give written informed consent
  • Exclusion criteria:
  • children (≤ 18 years) and adults 19-39years
  • any current or past clinically significant pathology/disease (comorbidity) such as:
  • Malignancies
  • Cardiovascular diseases
  • Diabetes mellitus (I and II)
  • Obesity class III (BMI >40)
  • Other severe diseases (e.g. renal, hepatic, thyroid disease, bone metabolic diseases, rheumatoid osteoarthritis, human immunodeficiency syndrome, ...)
  • Influenza group:
  • Inclusion criteria:
  • gender: female/male
  • age: ≥40 years
  • patients admitted at the emergency department
  • influenza suspected patients
  • able to give written informed consent
  • Exclusion criteria:
  • children (≤ 18 years) and adults 19-39 years
  • patients without definitive influenza confirmation

结局指标

主要结局

DNA damage

时间窗: Baseline

Compare DNA damage (% of DNA in the tail; measured by the comet assay) between hospitalized COVID-19 patients to influenza patients and healthy controls.

次要结局

  • The investigators will consider RDA and DNA gene expression(Baseline)
  • The investigators will consider oxidative stress marker(Baseline)
  • The investigators will consider inflammatory marker(Baseline)
  • The investigators will consider clinical biochemistry marker(Baseline)
  • The investigators will consider further DNA damage parameter(Baseline)
  • The investigators will consider the phenotypic age marker(Baseline)

研究者

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

Wagner Karl-Heinz

Professor of Human Nutrition

University of Vienna

研究点 (1)

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