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

NCT ID: NCT04970563

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-21

Study Completion Date

2022-01-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infection by SARS-COV-2 Healthy Controls

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Body odor samples

Intervention Type 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

Group Type OTHER

Body odor samples

Intervention Type OTHER

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

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

Group Type OTHER

Body odor samples

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Body odor samples

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hôpital Européen Marseille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Européen Marseille

Marseille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21-12

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Covid-19 Breath Test
NCT04459962 COMPLETED NA