Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for COVID-19 Infection. (VOCSARSCOVDep)
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.
調査の概要
状態
条件
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Elisabeth Hulier-Ammar, PhD
- 電話番号：0146251175
- メール：drci-promotion@hopital-foch.com
研究場所
-
-
-
Suresnes、フランス、92151
- 募集
- Foch Hospital
-
コンタクト：
- Hélène Salvator, MD
- 電話番号：0146252955
- メール：h.salvator@hopital-foch.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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.
訓練を受けた犬による汗中の VOC 分析。
VOC analysis in exhaled air with mass spectrometry.
VOC analysis in sweat with mass spectrometry.
|
|
他の：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.
訓練を受けた犬による汗中の VOC 分析。
VOC analysis in exhaled air with mass spectrometry.
VOC analysis in sweat with mass spectrometry.
|
|
他の：Asymptomatic patients or healthy volunteers
Patients or healthy volunteers with negative RT-PCR and negative serology
|
VOC analysis in exhaled air with e-noses.
訓練を受けた犬による汗中の VOC 分析。
VOC analysis in exhaled air with mass spectrometry.
VOC analysis in sweat with mass spectrometry.
|
|
他の：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.
訓練を受けた犬による汗中の VOC 分析。
VOC analysis in exhaled air with mass spectrometry.
VOC analysis in sweat with mass spectrometry.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Identify the nature of VOCs associated with infection by SARS-CoV-2 by mass spectrometry in exhaled air and in sweat
時間枠：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)
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2021_0013
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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