NCT05846074

Brief Summary

Considering the favorable preliminary data of few european diagnostic studies on dog detection, we develop in 2021 a pilot study in response to the plan of CHU Bordeaux and Nouvelle Aquitaine French region for an expanded, reliable and alternative rapid dog olfactory detection of COVID during pandemic period. Our hypothesis is that validated olfactory detection on sweat or face mask collection by dogs would increase the acceptability and propensity to be tested in different population groups, given the non-invasive nature of sweat and face mask; compared to the unpleasant aspect of nasal swabs for PCR or rapid antigenic tests. To reach this objective, we recruited a dog team to be trained and assessed (all-volunteers masters and dogs) and we will recruit participants with positive and negative PCR test. The diagnostic performance of canine olfactory detection of COVID-19 on sweat and face collection will be compared to the nasal SARS-Cov-2 PCR test of the participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,548

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
Last Updated

May 31, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

May 4, 2023

Last Update Submit

May 26, 2023

Conditions

Keywords

COVID-19dogcanineolfactorydiagnostic

Outcome Measures

Primary Outcomes (1)

  • Experimentally validate the intrinsic diagnostic performance of dogs for the olfactory detection of COVID-19

    Combined measurement of a Sensitivity \> 80% and a specificity \> 60% of each dog and of all the dogs eligible for the week of evaluation of the canine olfactory detection of COVID-19; compared to the SARS-Cov-2 PCR test (gold standard)

    day 1

Secondary Outcomes (4)

  • Experimentally validate the intrinsic performance

    day 1

  • Experimentally validate the intrinsic performance

    day 1

  • Canine olfactory detection on mask

    day 1

  • Evaluation of the intrinsic and discriminative diagnostic performance of dogs for the olfactory detection of COVID-19 on sweat samples and/or used respiratory masks

    day 1

Interventions

Collection of sweat samples and used face mask will take approximately 15 minutes before or after collection for the SARS-Cov PCR test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people screened by SARS-CoV2 PCR

You may not qualify if:

  • Confirmed or suspected long-haul symptoms of COVID-19 Patient subject to a judicial protection measure Person opposing the study (child or parent if minor) OR not understanding French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Hospital Bordeaux, France

Bordeaux, 33000, France

Location

Hospital Dax

Dax, 40107, France

Location

Hospital Libourne

Libourne, 33505, France

Location

University Hospital Limoges, France

Limoges, 87042, France

Location

Hospital Périgueux

Périgueux, 24019, France

Location

Universtity Hospital Poitiers

Poitiers, 86021, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection of sweat samples and face mask

MeSH Terms

Conditions

COVID-19AnosmiaDisease

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOlfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Thierry PISTONE, Dr

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 6, 2023

Study Start

May 27, 2021

Primary Completion

May 28, 2022

Study Completion

June 28, 2022

Last Updated

May 31, 2023

Record last verified: 2023-04

Locations