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Completed

NCT Number: NCT04614883

Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in the Context of Suspicion of COVID-19 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foch hospital

Suresnes, 92151, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients
  • Patents anaged at the Foch Hospital for suspected COVID-19 and any other patient whose management requires diagnosis of SARS-CoV-2 infection
  • Patients aged 18 or over;
  • Patients Fluent in French ;
  • Patients with a signed consent form;
  • Patients with a health insurance plan.
  • Healthy volunteers
  • Foch Hospital staff asymptomatic for SARS-CoV-2 infection;
  • Aged 18 yor over;
  • Fluent in french;
  • with a signed consent form;
  • With a health insurance plan.

Exclusion criteria

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

Treatment and study plan

Volatile Organic Compounds analysis

Device

VOC analysis in exhaled air with e-noses and mass spectrometry. VOC analysis in sweat with mass spectrometry.

Canine odor detection of Volatile Organic Compounds

Other

VOC analysis in sweat by trained dogs.

Primary outcomes

  1. Validate the interest of VOCs analyzed by electronic noses and / or mass spectrometry for the diagnosis of a COVID-19 infection

    Time frame: 1 day

    Comparison of variation of Volatile Organic Compound (VOC) profiles in exhaled air of patients between patients with symptoms suggestive of COVID and infection confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and those whose infection is ruled out based on the negativity of RT-PCR and clinical data

Secondary outcomes

  1. Identify the nature of VOCs associated with infection by SARS-CoV-2 by mass spectrometry in exhaled air and in sweat

    Time frame: 1 day

    The equivalences and differences in nature of VOCs associated with infection with SARS-CoV-2 between exhaled air and sweat.

  2. Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)

    Time frame: 1 day

    Proportion of success in detecting samples from patients with symptoms suggestive of COVID and infection confirmed by PCR.

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in Patients Referred to the Emergency Reception Service for Suspected COVID-19 Infection: Diagnostic Value and for Rapid Screening

Acronym: VOC-COVID-Diag

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 4, 2020
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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