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

NCT04970563 | Completed

• 1 other identifier: 21-12
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection by SARS-COV-2; Healthy Controls

Outcome Measures

Primary Outcomes (1)

• Percentage behavioral response of trained dogs obtained on sweat samples from patients infected by asymptomatic SARS-Cov-2.

  Six months

Study Arms (3)

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

EXPERIMENTAL

Other: Body odor samples

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

OTHER

Other: Body odor samples

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

OTHER

Other: Body odor samples

Interventions

Body odor samples OTHER

Participants will provide six body odor samples (mask and sweat samples) at inclusion

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".

You may not qualify if:

• \- Patient whose life expectancy is less than 3 months

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (1)

Hôpital Européen Marseille

Marseille, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 21, 2021
• Study Start: June 21, 2021
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: April 14, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)