COVID-19CYNOCOVNCT05846074
Diagnostic Performance of Dogs for the Olfactory Detection of COVID-19
An observational study of COVID-19, run by University Hospital, Bordeaux at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- sweat samples and used face mask will be collected
- How many people
- 1,548 participants
- Where
- 6 sitesFrance
- Study dates
- 27 May 2021to 28 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people screened by SARS-CoV2 PCR
Who may be able to join
- Criteria inclusion for "Case" participant Positive SARS-CoV-2 PCR test with significant viral load according to Ct <37 (high-speed extractor MGISP-960; used in CHU Bordeaux) or <34 (excluding high-speed extractor MGISP-960) Symptomatic person for a maximum of 7 days at the time of the sweat sample; or asymptomatic person with sweat sample within 72 hours of the PCR test.
- Criteria inclusion for witnessesControl participant Totally negative SARS-Cov-2 PCR test with sweat sampling within 72 hours Systematic screening (except in case of COVID-19 pre-contact ): air flight or surgical operation or unusual meeting or symptomatology or collective screening at the request of an organization Asymptomatic person (no unusual symptoms) for at least 1 month or unusual symptoms for at least of 48 hours and at mostof 5 days at the time of the PCR test
Who cannot join
- -Common non-inclusion criteria: Age less than 6 years old History of COVID-19 confirmed by PCR test or rapid test or Scanner between Day 8 and Day 35 of the onset of symptoms -or of the test if asymptomatic) History of taste and / or smell disorder (s) that occurred between the Day 8 and Day 35 before pre-inclusion.
- 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
- -Criteria for non-inclusion of witnessesControl participant : Contact case of COVID-19 for less than 35 days without having made PCR test between Day 5 and Day 8 of the contact Vaccination date against COVID of 7 days or less Professionals in human health or nursing homes or medical transport Woman in the middle of the menstrual cycle without pill or implant type contraception (ovulation) History of taste and / or smell disorders that occurred less than 7 days ago Hospitalization for more than 724 hours at the time of the sweat collection
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
University Hospital Bordeaux, France
Bordeaux, 33000
Hospital Dax
Dax, 40107
Hospital Libourne
Libourne, 33505
University Hospital Limoges, France
Limoges, 87042
Hospital Périgueux
Périgueux, 24019
Universtity Hospital Poitiers
Poitiers, 86021
About this study
Official title: 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.
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.
Read the 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
- Being tested
- sweat samples and used face mask will be collected
- Keywords
- COVID-19, dog, canine, olfactory, diagnostic
- Medical subject headings
- COVID-19, Anosmia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sweat samples and used face mask will be collectedDiagnostic test
Collection of sweat samples and used face mask will take approximately 15 minutes before or after collection for the SARS-Cov PCR test
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: day 1
Secondary outcomes (4)
Experimentally validate the intrinsic performance
Combined measurement of Sensitivity > 80% and Specificity > 60% of each dog and of all dogs eligible for the week of evaluation; in different subgroups of participants according to the presence of symptomatology, the presence of comorbidities, gender, hormonal cycle in women, taking medication, smoking and anti-COVID-19 vaccination
Measured: day 1
Experimentally validate the intrinsic performance
Combined sensitivity and specificity measurements for all dogs according to canine characteristics (breed, age, experience) and canine detection procedures (start or end of line, test days, sequence effects).
Measured: day 1
Canine olfactory detection on mask
High concordance kappa coefficient of detection performance between the respiratory mask and the sweat samples (axillary and/or neck).
Measured: 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
mesure combinée pour les chiens, d'une Sensibilité > 80%, d'une spécificité > 60% et des valeur prédictives positive et négative qui dépendront de la prévalence de la COVID-19 au sein de l'échantillon qui sera recruté consécutivement sans discrimination de sous-population
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start27 May 2021
- Primary completion28 May 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,548 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry PISTONE, Dr, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846074
- Sponsor's protocol ID
- CHUBX 2021/05
- Acronym
- CYNOCOV
- Status last verified
- Apr 2023
- First submitted
- 4 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05846074
- Acronym / sponsor ID
- CYNOCOV / CHUBX 2021/05
- Conditions
- COVID-19
- Keywords
- COVID-19, dog, canine, olfactory, diagnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,548 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people screened by SARS-CoV2 PCR
Key inclusion criteria (2 listed)
- Criteria inclusion for "Case" participant Positive SARS-CoV-2 PCR test with significant viral load according to Ct <37 (high-speed extractor MGISP-960; used in CHU Bordeaux) or <34 (excluding high-speed extractor MGISP-960) Symptomatic person for a maximum of 7 days at the time of the sweat sample; or asymptomatic person with sweat sample within 72 hours of the PCR test.
- Criteria inclusion for witnessesControl participant Totally negative SARS-Cov-2 PCR test with sweat sampling within 72 hours Systematic screening (except in case of COVID-19 pre-contact ): air flight or surgical operation or unusual meeting or symptomatology or collective screening at the request of an organization Asymptomatic person (no unusual symptoms) for at least 1 month or unusual symptoms for at least of 48 hours and at mostof 5 days at the time of the PCR test
Key exclusion criteria (3 listed)
- -Common non-inclusion criteria: Age less than 6 years old History of COVID-19 confirmed by PCR test or rapid test or Scanner between Day 8 and Day 35 of the onset of symptoms -or of the test if asymptomatic) History of taste and / or smell disorder (s) that occurred between the Day 8 and Day 35 before pre-inclusion.
- 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
- -Criteria for non-inclusion of witnessesControl participant : Contact case of COVID-19 for less than 35 days without having made PCR test between Day 5 and Day 8 of the contact Vaccination date against COVID of 7 days or less Professionals in human health or nursing homes or medical transport Woman in the middle of the menstrual cycle without pill or implant type contraception (ovulation) History of taste and / or smell disorders that occurred less than 7 days ago Hospitalization for more than 724 hours at the time of the sweat collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sweat samples and used face mask will be collectedCollection of sweat samples and used face mask will take approximately 15 minutes before or after collection for the SARS-Cov PCR test | Diagnostic test | – |
Primary outcome
Experimentally validate the intrinsic diagnostic performance of dogs for the olfactory detection of COVID-19
Time frame: day 1
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)
4 secondary outcomes
Experimentally validate the intrinsic performance
Time frame: day 1
Experimentally validate the intrinsic performance
Time frame: day 1
Canine olfactory detection on mask
Time frame: 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
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry PISTONE, Dr principal investigator
University Hospital Bordeaux, France
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University Hospital, Bordeaux at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experimentally validate the intrinsic diagnostic performance of dogs for the olfactory detection of COVID-19 (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.