Detection of Asymptomatic SARS-Cov2 Infected Patients by Detection Dogs: "Proof of Concept" Study (CoviDetectionDog)-Covid-19

Hôpital Européen Marseille

Status: Completed

Conditions: Infection by SARS-COV-2; Healthy Controls

Treatments: Other: Body odor samples

Study type: Interventional

Funder types: Other

Identifiers

NCT04970563

21-12

Details and patient eligibility

About

The spread of the new SARS-CoV-2 virus has led to a pandemic. Described for the first time in China at the end of 2019, it causes Covid-19 disease. Its characteristics in terms of contagiousness and lethality have led countries to adapt their screening and care strategies.

Early and accurate identification of people infected with SARs-CoV-2 is an essential measure to confront Covid-19 pandemic. A key aspect of Covid-19 is that diagnostic tests must be able to detect the virus in asymptomatic, pre-symptomatic and symptomatic patients.

Changes in human odor, as symptoms of specific diseases, have been observed. Dogs have already been used to detect breast or lung cancer, diabetes, epilepsy or kidney disease with some success There is currently a growing body of research and previous work, though preliminary, indicating the possibility that dogs identify persons infected with Sars-Cov-2 compared to healthy persons.

The purpose of this study is to determine whether trained detection dogs are able to identify asymptomatic patients infected by Sars-Cov-2.

The investigators aim to validate the possibility to identify / discriminate patients with Covid-19 according to their odor by a proof of concept (with specificity and sensitivity of the detection test), i.e. new non-invasive screening method using dogs odor detection capabilities.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged ≥ 18 years
• Having given free and informed written consent
• Being affiliated to the center national security system social
• Patients infected by SARS-COV-2 with positive RT PCR on nasopharyngeal swab and without symptoms (fever, cough, anosmia, diarrhea) will be included in "experimental" Group 1.
• Patients infected by SARS COV 2 with positive RT PCR on nasopharyngeal swab and presenting at least one symptom will be included in Group 2 "control".
• Participants not infected by SARS-COV-2 with negative RT PCR on nasopharyngeal sample and showing no symptoms on Day 0 and Day 7 will be included in Group 3 "healthy controls".

Exclusion criteria

• Patient whose life expectancy is less than 3 months

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 3 patient groups

Patients infected by SARS-COV-2 (RT-PCR +) and asymptomatic

Experimental group

Treatment:

Other: Body odor samples

Other: Body odor samples

"Control" group: patients infected by SARS-COV-2 (RT-PCR +) and symptomatic

Other group

Treatment:

Other: Body odor samples

Other: Body odor samples

"Healthy controls" group: not infected by SARS-COV-2 (RT-PCR-) and asymptomatic.

Other group

Treatment:

Other: Body odor samples

Other: Body odor samples