跳至主要内容
临床试验/NCT04410432
NCT04410432已完成不适用

Immune Response and Risk of Serious Infection to SARS-Cov2

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2020年9月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
Percentage of circulating Th1 lymphocytes

研究概览

简要总结

To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%.

Apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Person having given his or her non-opposition
  • Patient hospitalized with an SARS-Cov2 infection proven by virological sampling (nasopharyngeal or sputum PCR) less than 8 days old.

排除标准

  • Person subject to a legal protection measure (curatorship, guardianship)
  • Person subject to a safeguard measure of justice
  • Pregnant, parturient or breastfeeding woman
  • Major incapable or incapable of giving consent

研究组 & 干预措施

Patient

Patient hospitalized with SARS-Cov2 infection proven by virological sampling.

干预措施: Blood sample collection (Biological)

结局指标

主要结局

Percentage of circulating Th1 lymphocytes

时间窗: Until the end of the study, about 12 months.

Flow cytometry measurement of the percentage of circulating Th1 lymphocytes

次要结局

  • Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11(Until the end of the study, about 12 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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