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

Detection of Asymptomatic SARS-Cov2 Infected Patients by Detection Dogs: "Proof of Concept" Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy Controls; Infection by SARS-COV-2
• Intervention / Treatment: Other: Body odor samples; Other: Body odor samples

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Hôpital Européen Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients infected by SARS-COV-2 (RT-PCR +) and asymptomatic	Other: Body odor samples; Participants will provide six body odor samples (mask and sweat samples) at inclusion; Other: Body odor samples; Participants will provide six body odor samples (masks and compresses) at inclusion. A 7-day follow-up will be carried out to check, respectively, the absence of symptoms and the persistence of negativity on the SARS-COV-2 PCR test
Other: "Control" group: patients infected by SARS-COV-2 (RT-PCR +) and symptomatic	Other: Body odor samples; Participants will provide six body odor samples (mask and sweat samples) at inclusion; Other: Body odor samples; Participants will provide six body odor samples (masks and compresses) at inclusion. A 7-day follow-up will be carried out to check, respectively, the absence of symptoms and the persistence of negativity on the SARS-COV-2 PCR test
Other: "Healthy controls" group: not infected by SARS-COV-2 (RT-PCR-) and asymptomatic.	Other: Body odor samples; Participants will provide six body odor samples (mask and sweat samples) at inclusion; Other: Body odor samples; Participants will provide six body odor samples (masks and compresses) at inclusion. A 7-day follow-up will be carried out to check, respectively, the absence of symptoms and the persistence of negativity on the SARS-COV-2 PCR test

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hôpital Européen Marseille

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 21-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No