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

Sponsor
Hôpital Européen Marseille (Other)
Overall Status
Completed
CT.gov ID
NCT04970563
Collaborator
(none)
160
1
3
6.8
23.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Body odor samples
  • Other: Body odor samples
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Detection of Asymptomatic SARS-Cov2 Infected Patients by Detection Dogs: "Proof of Concept" Study
Actual Study Start Date :
Jun 21, 2021
Actual Primary Completion Date :
Jan 14, 2022
Actual Study Completion Date :
Jan 14, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

  1. Percentage behavioral response of trained dogs obtained on sweat samples from patients infected by asymptomatic SARS-Cov-2. [Six months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Européen Marseille Marseille France

Sponsors and Collaborators

  • Hôpital Européen Marseille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hôpital Européen Marseille
ClinicalTrials.gov Identifier:
NCT04970563
Other Study ID Numbers:
  • 21-12
First Posted:
Jul 21, 2021
Last Update Posted:
Apr 14, 2022
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 14, 2022