NCT05846074

Diagnostic Performance of Dogs for the Olfactory Detection of COVID-19

Pilot Study for the Experimental Validation of the Intrinsic Diagnostic Performance Among the First Dod Team for the Canine Olfactory Detection of COVID-19 on Sweat Samples From Persons Tested by PCR SARS-CoV-2.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,548 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The design of the study is an open,interventional risk-free, multi-centre diagnostic validation pilot sudy The main objective is the experimental assessment of the intrinsic diagnostic performance (sensitivity, specificity) among the first dog team in Nouvelle Aquitaine French region for the canine olfactory detection of COVID-19 on sweat samples from persons tested by PCR SARS-CoV-2. The secondary objectives are : * the experimental assessment of the intrinsic diagnostic performance (sensitivity, specificity) according to different factors: symptomatic or not, comorbidity, gender, hormonal cycle of women, medication taking, anti-COVID-19 vaccination, canine characteristics and canine detection procedures. * Proof of concept of canine olfactory detection performance with a used face mask. * Determine the biochemical composition of the volatile organic compound(s) (VOCs) associated with COVID-19 and detected by the dogs team. * the assessment of intrinsic and discriminating diagnostic performance (positive and negative predictive values) of dogs for the olfactory detection of COVID-19 on used sweat and/or face mask based on the symptomatology. This study will be conducted in two phases: \- Phase 1: experimental assessment of the intrinsic diagnostic performance (sensitivity, specificity) among the first dogs team in Nouvelle Aquitaine French region for the canine olfactory detection of COVID-19 on sweat samples and face mask from persons tested by PCR SARS-CoV-2. The experimental assessment of the phase 1 wil include two experimental subpopulation samples of people tested by PCR SARS-CoV-2: positive, symptomatic or non-symptomatic (Case subpopulation); and negative non-case-contact, symptomatic or non-symptomatic (Control subpopulation). \- Phase 2: Near-routine live assessment of intrinsic and discriminating diagnostic performance (positive and negative predictive values) of dogs for the olfactory detection of COVID-19 on sweat collection and/or used face mask of persons rountinely screened by PCR SARS-CoV-2. These persons will be recruited consecutively without discrimination of subpopulations.

Conditions

• COVID-19

Interventions

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

Timeline

• Start date: 2021-05-27
• Primary completion: 2022-05-28
• Completion: 2022-06-28
• First posted: 2023-05-06
• Last updated: 2023-05-31

Locations

6 sites across 1 country: France