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

Not Applicable

Completed

• Conditions: Healthy Controls; Infection by SARS-COV-2
• Interventions: Other: Body odor samples

• Registration Number: NCT04970563
• Lead Sponsor: Hôpital Européen Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-16
• Study Start: 2021-06-21
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-21
• Primary Completion: 2022-01-14
• Study Completion: 2022-01-14
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Healthy controls" group: not infected by SARS-COV-2 (RT-PCR-) and asymptomatic.	Body odor samples	-
"Control" group: patients infected by SARS-COV-2 (RT-PCR +) and symptomatic	Body odor samples	-
Patients infected by SARS-COV-2 (RT-PCR +) and asymptomatic	Body odor samples	-

Primary Outcome Measures

Name	Time	Method
Percentage behavioral response of trained dogs obtained on sweat samples from patients infected by asymptomatic SARS-Cov-2.	Six months

Trial Locations

Locations (1)

Hôpital Européen Marseille; 🇫🇷 Marseille, France