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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Elisabeth Hulier-Ammar, PhD
- Número de teléfono: 0146251175
- Correo electrónico: drci-promotion@hopital-foch.com
Ubicaciones de estudio
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Suresnes, Francia, 92151
- Reclutamiento
- Foch Hospital
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Contacto:
- Hélène Salvator, MD
- Número de teléfono: 0146252955
- Correo electrónico: h.salvator@hopital-foch.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Symptomatic patients with positive PCR
Patients with symptoms of COVID-19 and whose PCR result is positive
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VOC analysis in exhaled air with e-noses.
Análisis de COV en sudor por perros entrenados.
VOC analysis in exhaled air with mass spectrometry.
VOC analysis in sweat with mass spectrometry.
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Otro: 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
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VOC analysis in exhaled air with e-noses.
Análisis de COV en sudor por perros entrenados.
VOC analysis in exhaled air with mass spectrometry.
VOC analysis in sweat with mass spectrometry.
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Otro: Asymptomatic patients or healthy volunteers
Patients or healthy volunteers with negative RT-PCR and negative serology
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VOC analysis in exhaled air with e-noses.
Análisis de COV en sudor por perros entrenados.
VOC analysis in exhaled air with mass spectrometry.
VOC analysis in sweat with mass spectrometry.
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Otro: Volunteers or patients vaccinated against COVID-19
Volunteers or patients vaccinated against COVID-19 (complete vaccination scheme)
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VOC analysis in exhaled air with e-noses.
Análisis de COV en sudor por perros entrenados.
VOC analysis in exhaled air with mass spectrometry.
VOC analysis in sweat with mass spectrometry.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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.
Periodo de tiempo: 1 day
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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.
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1 day
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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.
Periodo de tiempo: 1 day
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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.
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1 day
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Identify the nature of VOCs associated with infection by SARS-CoV-2 by mass spectrometry in exhaled air and in sweat
Periodo de tiempo: 1 day
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The equivalences and differences in nature of VOCs associated with infection with SARS-CoV-2 between exhaled air and sweat identified by mass spectrometry.
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1 day
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Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)
Periodo de tiempo: 1 day
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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
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2021_0013
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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