Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in the Context of Suspicion of COVID-19 Infection (VOC-COVID-Diag)

Hopital Foch

Status: Completed

Conditions: Covid19

Treatments: Other: Canine odor detection of Volatile Organic Compounds; Device: Volatile Organic Compounds analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT04614883

2020_0143

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

2. 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 3 patient groups

Asymptomatic patients or Healthy volunteers

Other group

Description:

Patient with no symptom of COVID-19 infection but for whom a PCR test needs to be done because he has been in contact with a COVID-19 positive person

Treatment:

Other: Canine odor detection of Volatile Organic Compounds

Device: Volatile Organic Compounds analysis

Symptomatic patients with positive PCR

Other group

Description:

Patients with symptoms of COVID-19 and whose PCR result is positive

Treatment:

Other: Canine odor detection of Volatile Organic Compounds

Device: Volatile Organic Compounds analysis

Symptomatic patients with negative PCR but with seroconversion within 4 to 8 weeks

Other group

Description:

Patients with symptoms of COVID-19 and whose PCR result is negative at inclusion but presents a seroconversion within 4 to 8 weeks post inclusion

Treatment:

Other: Canine odor detection of Volatile Organic Compounds

Device: Volatile Organic Compounds analysis