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临床试验/NCT04716907
NCT04716907已完成不适用

Thymic Function in Patients With COVID-19

CMC Ambroise Paré1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2021年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
85
试验地点
1
主要终点
Genetic Predisposition to severe forms of COVID-19

研究概览

简要总结

The main clinical manifestation associated with SARS-CoV-2 infection is an influenza-like illness that follows the infection of the respiratory tract. In a few percent of infected people, inflammation of the lungs leads to severe pneumonia that requires hospitalization, in intensive care units for the more severe cases. Despite intensive care, a fatal outcome occurs in 6% and 12% of women and men over 80 years of age hospitalized for severe COVID, respectively.

Factors associated with a higher risk of death in patients with SARS-CoV-2 include age and low circulating lymphocyte counts. Significant lymphopenia is indeed frequently observed in patients with severe COVID-19 and both phenotypic and functional changes in antiviral T cells have been correlated with the severity of COVID-19.

The thymus, the organ that produces T lymphocytes, undergoes progressive physiological involution with age. However, in the elderly, rare cases of thymic hyperplasia are reported in autoimmune diseases or cancers, or are observed in response to deep lymphopenia, whether or not associated with sepsis.

This cohort of patients treated for a SARS-CoV-2 infection could allow to better understand the role of the thymus in this pathology.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with confirmed COVID-19 infection
  • •Hospitalized for COVID-19 infection
  • •Having signed a written informed consent form
  • •Affiliation to the social security system
  • •Non-COVID-19 patients
  • •Hospitalized for other reasons
  • •Age and sex-matched controls
  • •Having signed a written informed consent form,
  • •Affiliation to the social security system

排除标准

  • •Autoimmune disease
  • •HIV, Hepatitis B or Hepatitis C
  • •Pregnant or breastfeeding women
  • •A mental or linguistic inability to understand the study
  • •Patient under protection of the adults (guardianship, curators or safeguard of justice)

结局指标

主要结局

Genetic Predisposition to severe forms of COVID-19

时间窗: through study completion, average 1 year

Test of association between single-nucleotide polymorphisms (SNP) within the TCRA/D region known to influence the level of thymopoiesis (Clave et al., Sci Transl Med., 2018) and CT scan classification of COVID-associated pneumopathy (0=Absent or minor pulmonary parenchymal changes ; 1=Limited ground-glass opacities ; 2=Bilateral ground-glass opacities \< 50% of pulmonary parenchyma ; 3=Idem 2, with superimposed inter/intra lobular septal thickening, i.e. 'crazy paving' ; 4=Bilateral ground-glass opacities \> 50% of pulmonary parenchyma ; 5=Idem 4, with superimposed 'crazy paving' ; 6=Idem 5, with pulmonary fibrosis).

次要结局

  • Immune response in COVID patients(through study completion, average 1 year)
  • Immune response in lungs of COVID patients(through study completion, average 1 year)
  • Genetic Predisposition to thymic enlargement observed during COVID-19 infection(through study completion, average 1 year)
  • Genetic Predisposition to enhanced thymic function during COVID-19 infection(through study completion, average 1 year)
  • Genetic Predisposition to severity of COVID-19 pathology(through study completion, average 1 year)
  • Basal thymic function in COVID patients(through study completion, average 1 year)
  • Thymic function in COVID patients(through study completion, average 1 year)
  • Inflammatory response in COVID patients(through study completion, average 1 year)

研究者

发起方
CMC Ambroise Paré
申办方类型
Other
责任方
Sponsor

研究点 (1)

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