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

Healthy Controls Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04970563
• Other study ID #: 21-12
• Status: Completed
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: January 14, 2022

Study information

• Verified date: June 2021
• Source: Hôpital Européen Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Healthy Controls

Intervention

Other:
• Body odor samples
Participants will provide six body odor samples (mask and sweat samples) at inclusion
• 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

Locations

Country	Name	City	State
France	Hôpital Européen Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage behavioral response of trained dogs obtained on sweat samples from patients infected by asymptomatic SARS-Cov-2.		Six months