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临床试验/NCT04355351
NCT04355351已完成不适用

Study of Immune Response During SARS-CoV-2 Infection

Centre Hospitalier Universitaire de Nice4 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2020年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
303
试验地点
4
主要终点
Level of IFN-gamma after a non-specific stimulation of T lymphocytes

研究概览

简要总结

Study of the cellular immune response during the SARS-CoV-2 infection and identify cytokinic profiles in caregivers exposed to the virus with asymptomatic forms of COVID19, patients with an asymptomatic form followed in ambulatory care and patients hospitalized in the infectious disease department or in resuscitation at the CHU de Nice COVID-19 according to their clinical symptomatology and the kinetics of clinical aggravation using functional tests evaluating the Th1 type immune response.

The project is divided into a clinical component comprising the study of the immune response in different populations and a cellular component focusing on the in vitro study of different immunomodulating treatments on their ability to induce an anti-viral Th1

详细描述

Since March 2020, Europe has been facing the spread of Coronavirus disease 2019 (COVID-19), an emerging infectious disease of viral zoonosis type, caused by the coronavirus SARS-CoV-21. This virus is responsible for an epidemic in Wuhan in November 2019 and a pandemic in March 2020. The mode of transmission, both respiratory and by contact, carried by microdroplets emitted by an infected person and inhaled by a person nearby, induces a very high contagiousness rate2. In the majority of cases, CoV-2-SARS infection is not very symptomatic, but some evolve into severe forms, particularly in frail people: elderly subjects, those affected by chronic diseases (diabetes, obesity or cancer) or those undergoing immunosuppressive treatments. There is still little information on the reasons why some will develop a severe form while others will remain asymptomatic. The immune response is little studied in this context.

Functional study of the cellular immune response has shown its interest in predicting the risk of infection in different cohorts, particularly in renal insufficiency subjects awaiting transplantation with an over-risk of developing an infection within a year in patients with a low level of gamma interferon (INFγ: main anti-viral cytokine) after non-specific stimulation of T lymphocytes.

A study published the clinical characteristics of 41 patients infected with coronavirus at the Huanan seafood market (first contact cases). Despite a similar clinical symptomatology: cough (76%) and fever (98%), some patients required rapid ventilatory assistance. These patients had an increased production of inflammatory cytokines: IL2, IL7, IL10, GSCF, IP10, MCP1, MIP1A, and TNFα3.

Here, the objective is to identify cytokine profiles in subjects exposed to or infected with SARS-CoV-2 that can predict their risk of developing a severe pauci-symptomatic form at the time of exposure or during the development of a severe form. the team believes that the immune response to this infection is a major factor in the risk of developing an asymptomatic infection, a flu-like symptomatology or a respiratory failure syndrome (ARDS).3,4 The team believes that the immune response to this infection is a major factor in the risk of developing an asymptomatic infection, a flu-like symptomatology or a respiratory failure syndrome (ARDS). The team thus wishes to better direct patients to appropriate care structures to optimise the care pathway (ambulatory, infectiology, intensive care), respirators and number of beds so as not to overload the staff) and to enable treatments to be personalised and adapted as best as possible: corticosteroids, immunomodulators, antivirals.

The study will be based on 2 axes: a first clinical axis (i) and a cellular axis (ii).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Level of IFN-gamma after a non-specific stimulation of T lymphocytes

时间窗: 6 months

Peripheral T lymphocytes will be stimulated with an anti-CD3 for 16-24h. The Level of IFN-gamma (pg/mL) will be defined using an automated ELISA test (Protein Simple) on the stimulated and non-stimulated plasma.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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