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Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for COVID-19 Infection. (VOCSARSCOVDep)

2022年8月2日 更新者:Hopital Foch

Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for SARS-CoV-2 Infection.

In the context of the actual pandemia of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which requires a better diagnostic strategy for the management of patients.

The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The analysis of VOC can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.

Moreover, it has recently been shown that properly trained dogs would be able to detect an olfactory signature of SARS-CoV-2 infection with a specificity greater than 90%; this olfactory signature corresponds to VOCs detectable by the flair of dogs (Nosaïs-Covid19 study).

Validation of the diagnostic value of VOC analyzes by non-invasive and rapid methods (electronic nose analysis or mass spectrometry; detection by the scent of dogs) for the rapid detection and early diagnosis of a SARS-CoV-2 infection warrants the performance of this clinical study.

研究概览

研究类型

介入性

注册 (预期的)

192

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Subject included in the Foch Hospital :
  • Patients managed at the Foch Hospital with RT-PCR screening for SARS-CoV-2 infection
  • Healthy volunteers among the hospital staff, asymptomatic, for whom an RT-PCR SARS-CoV-2 is indicated or recommended.
  • Healthy hospital volunteers vaccinated against COVID (full vaccination schedule completed)
  • At least 18 years of age;
  • Fluency in the French language;
  • Have signed a consent form;
  • Be affiliated with a health insurance plan.

Exclusion Criteria:

  • Pregnant woman
  • Patient deprived of liberty by judicial or administrative decision

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Symptomatic patients with positive PCR
Patients with symptoms of COVID-19 and whose PCR result is positive
VOC analysis in exhaled air with e-noses.
受过训练的狗对汗液中的 VOC 进行分析。
VOC analysis in exhaled air with mass spectrometry.
VOC analysis in sweat with mass spectrometry.
其他:Symptomatic patients with positive PCR for other respiratory virus
Patients with symptomatic respiratory disease of infectious origin with negative RT-PCR for SARS-CoV-2 and positive RT-PCR for other respiratory viruses
VOC analysis in exhaled air with e-noses.
受过训练的狗对汗液中的 VOC 进行分析。
VOC analysis in exhaled air with mass spectrometry.
VOC analysis in sweat with mass spectrometry.
其他:Asymptomatic patients or healthy volunteers
Patients or healthy volunteers with negative RT-PCR and negative serology
VOC analysis in exhaled air with e-noses.
受过训练的狗对汗液中的 VOC 进行分析。
VOC analysis in exhaled air with mass spectrometry.
VOC analysis in sweat with mass spectrometry.
其他:Volunteers or patients vaccinated against COVID-19
Volunteers or patients vaccinated against COVID-19 (complete vaccination scheme)
VOC analysis in exhaled air with e-noses.
受过训练的狗对汗液中的 VOC 进行分析。
VOC analysis in exhaled air with mass spectrometry.
VOC analysis in sweat with mass spectrometry.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The first co-objective of this experimental study is to determine if VOCs analyzed by electronic noses are of interest for the diagnosis of an infection by SARS-CoV-2 (COVID-19) infection.
大体时间:1 day
Identification of VOC profiles specific to the SARS-CoV-2 (VOC analysis by electronic noses) on exhalates collected under resting breathing conditions between patients with symptoms suggestive of COVID-19 and SARS-CoV-2 infection confirmed by RT-PCR, those whose infection is ruled out on the basis of the negativity RT-PCR and clinical/radiological data (non-COVID control patients), and those with another symptomatic respiratory viral infection confirmed by positive PCR for viruses other than SARS-CoV-2 other than SARS-CoV-2.
1 day
The second co-objective of this experimental study is to determine if VOCs analyzed by mass spectrometry is of interest for the diagnosis of an infection by SARS-CoV-2 (COVID-19) infection.
大体时间:1 day
Identification of VOC profiles specific to the SARS-CoV-2 (VOC analysis by mass spectrometry) on exhalates collected under resting breathing conditions between patients with symptoms suggestive of COVID and SARS-CoV-2 infection confirmed by RT-PCR, those whose infection is ruled out on the basis of the negativity RT-PCR and clinical/radiological data (non-COVID control patients), and those with another symptomatic respiratory viral infection confirmed by positive PCR for viruses other than SARS-CoV-2 other than SARS-CoV-2.
1 day

次要结果测量

结果测量
措施说明
大体时间
Identify the nature of VOCs associated with infection by SARS-CoV-2 by mass spectrometry in exhaled air and in sweat
大体时间:1 day
The equivalences and differences in nature of VOCs associated with infection with SARS-CoV-2 between exhaled air and sweat identified by mass spectrometry.
1 day
Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)
大体时间:1 day

Success rate of dogs trained in detecting COVID-19 from sweat samples taken from participating patients.

The status of patients (infected and uninfected with COVID-19 from the result of the PCR) will be compared to the result of the canine olfactory detection of COVID-19 in sweat samples.

1 day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月1日

初级完成 (预期的)

2022年9月1日

研究完成 (预期的)

2022年9月1日

研究注册日期

首次提交

2021年3月15日

首先提交符合 QC 标准的

2021年3月25日

首次发布 (实际的)

2021年3月26日

研究记录更新

最后更新发布 (实际的)

2022年8月3日

上次提交的符合 QC 标准的更新

2022年8月2日

最后验证

2022年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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