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临床试验/NCT04648709
NCT04648709终止不适用

Evaluation and Longitudinal Follow-up of Biomarkers Predictive of Severe Forms of COVID-19

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2021年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
73
试验地点
1
主要终点
T cell immune response

研究概览

简要总结

Current data in the literature demonstrate that the immune response to CoV-2-SARS is much more complex than initially assumed. In fact, beyond the humoral response, including the existence of neutralizing CAs, the adaptive lymphocyte T-type immune response also appears to play an important role in controlling the infection and reducing the severity of the disease. At this stage, the analysis of this T response is still rudimentary and underdeveloped, but it seems crucial to be able to analyze it effectively in COVID-19 patients, which could help predict the evolution of the infection. It is also currently difficult to know the evolution of this response over time and especially after the resolution of the infection.

To this end, we will analyze the T lymphocyte response (ELISPOT and QUANTIFERON) based on the secretion of IFN (Th1) and IL-4 (Th2) by CoV-2-SARS specific T cells from COVID-19 patients. We will compare the T response to the quality of the systemic and mucosal humoral response. Finally, we will evaluate in parallel two new biomarkers of the severity of COVID-19: plasma calprotectin and the presence of antibodies to type 1 IFN antibodies.

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

  • Social security affiliation
  • Signed informed consent
  • Patients with COVID infection documented by PCR and/or antigenic testing
  • Patients belonging to the following groups:
  • asymptomatic patients with PCR-positive PCR
  • patients with mild symptoms and PCR positive
  • seriously symptomatic patients with PCR positive
  • patients in resuscitation with positive PCR
  • Healthy individuals as controls

排除标准

  • haemoglobin < 8g/dL
  • Pregnancy, breastfeeding woman
  • Patient vaccinated within 15 days prior to inclusion

结局指标

主要结局

T cell immune response

时间窗: from baseline to 18 months

Characterize T-cell immune response in patient with COVID 19 infection

次要结局

  • B cell immune response(from baseline to 18 months)
  • Immune response and chronic forms(from baseline to 18 months)
  • Platelet immune response(from baseline to 18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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