COVID-19COVDOGNCT05205655
Detection Dogs as a Help in the Detection of COVID-19
A study testing collection of odour samples in people with COVID-19, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
Trial summary
Canine olfactive detection has proven its efficacy in numerous situations (explosives, drugs, bank notes…) including for early diagnosis of human diseases: various cancers, alert of diabetic or epileptic people in immediate alarm of crisis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- collection of odour samples
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2021to 31 Aug 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Due to have a coronavirus swab test in the previous 24 hours
- Aged ≥ 18 years
- Suspected mild COVID-19 symptoms or have been exposed to COVID-19
- Written informed consent provided
Who cannot join
- Aged < 18 years
- Written informed consent not provided
- Unable or unwilling to put a compresses for at least 4 h
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Canine Olfactory Detection and Its Relevance for the Medical Identification of Patients With COVID-19
Canine olfactive detection has proven its efficacy in numerous situations (explosives, drugs, bank notes…) including for early diagnosis of human diseases: various cancers, alert of diabetic or epileptic people in immediate alarm of crisis.
Read the detailed description
Fighting such a viral outbreak requires a widespread testing, one of the key measures for tackling the pandemic. In June 2020, facing a decline of COVID-19, it is possible to say that countries that have mastered their outbreak, and were able to maintain the number of infected people low, need to perform fewer test to correctly monitor the outbreak, than those countries where the virus has spread more widely. And for the same reasons, the timing of testing is also crucial. A high rate of testing will be way more effective to slow an outbreak if conducted earlier on, at a time when there is fewer infectious
The aim of this study is to evaluate if the sweat produced by COVID-19 persons (SARS-CoV-2 PCR positive) has a different odour for trained detection dogs than the sweat produced by non COVID-19 persons. The study was conducted on 3 sites, following the same protocol procedures, and involved a total of 18 dogs. A total of 198 armpits sweat samples were obtained from different hospitals. For each involved dog, the acquisition of the specific odour of COVID-19 sweat samples required from one to four hours, with an amount of positive samples sniffing ranging from four to ten.
- Conditions
- COVID-19
- Being tested
- collection of odour samples
- Keywords
- Biomedical detection dogs; Olfaction; Olfactory sense; Screening method; Sniffer dogs
- Medical subject headings
- COVID-19, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of odour samplesBehavioural
Odours will be collected by participants by putting sterile compresses under the armpits for at least 4 h.
| Study group | Role | What they receive |
|---|---|---|
| positive group | Active comparator | asymptomatic or mildly symptomatic participants positive for SARS-CoV-2 RNA Receives: Behavioral: collection of odour samples |
| negative group | Experimental | no evidence of SARS-CoV-2 by real-time RT-PCR Receives: Behavioral: collection of odour samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity precision of dogs to detect people with COVID-19 by their odour.
The main study is designed to measure the sensitivity and specificity of the dogs to detect participants infected with SARS-CoV-2. Dogs will be trained in K9 dog center for a period of 6-8 weeks to give a behavior response to positive samples. During training the reaction of each dog to a positive sample will be observed (i.e. standing, sitting or lying down) and this indicating behaviour reinforced by rewarding the dog. The dog's diagnostic accuracy will then be determined in a double-blinded study. Here the trainer and technician using the computer to record the results of the study are blinded to the identity of each sample until the trainer calls the final decision (positive or negative) based on the response of the dog to the sample.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Mar 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Sahloul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Boukef, Hôpital Universitaire Sahloul
- Investigators
- Riadh Boukef, professor, Principal investigator, CHU Sahloul, Sousse, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205655
- Sponsor's protocol ID
- CovDog
- Acronym
- COVDOG
- Status last verified
- Apr 2023
- First submitted
- 23 Jan 2022
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canine Olfactory Detection and Its Relevance for the Medical Identification of Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05205655
- Acronym / sponsor ID
- COVDOG / CovDog
- Conditions
- COVID-19
- Keywords
- Biomedical detection dogs; Olfaction; Olfactory sense; Screening method; Sniffer dogs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 25 Jan 2022 (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.
Canine olfactive detection has proven its efficacy in numerous situations (explosives, drugs, bank notes…) including for early diagnosis of human diseases: various cancers, alert of diabetic or epileptic people in immediate alarm of crisis.
Detailed description
Fighting such a viral outbreak requires a widespread testing, one of the key measures for tackling the pandemic. In June 2020, facing a decline of COVID-19, it is possible to say that countries that have mastered their outbreak, and were able to maintain the number of infected people low, need to perform fewer test to correctly monitor the outbreak, than those countries where the virus has spread more widely. And for the same reasons, the timing of testing is also crucial. A high rate of testing will be way more effective to slow an outbreak if conducted earlier on, at a time when there is fewer infectious
The aim of this study is to evaluate if the sweat produced by COVID-19 persons (SARS-CoV-2 PCR positive) has a different odour for trained detection dogs than the sweat produced by non COVID-19 persons. The study was conducted on 3 sites, following the same protocol procedures, and involved a total of 18 dogs. A total of 198 armpits sweat samples were obtained from different hospitals. For each involved dog, the acquisition of the specific odour of COVID-19 sweat samples required from one to four hours, with an amount of positive samples sniffing ranging from four to ten.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| positive group | Active comparator | Behavioral: collection of odour samplesasymptomatic or mildly symptomatic participants positive for SARS-CoV-2 RNA |
| negative group | Experimental | Behavioral: collection of odour samplesno evidence of SARS-CoV-2 by real-time RT-PCR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Due to have a coronavirus swab test in the previous 24 hours
- Aged ≥ 18 years
- Suspected mild COVID-19 symptoms or have been exposed to COVID-19
- Written informed consent provided
Key exclusion criteria (3 listed)
- Aged < 18 years
- Written informed consent not provided
- Unable or unwilling to put a compresses for at least 4 h
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 |
|---|---|---|
| collection of odour samplesOdours will be collected by participants by putting sterile compresses under the armpits for at least 4 h. | Behavioural | negative group, positive group |
Primary outcome
Sensitivity and specificity precision of dogs to detect people with COVID-19 by their odour.
Time frame: 1 months
The main study is designed to measure the sensitivity and specificity of the dogs to detect participants infected with SARS-CoV-2. Dogs will be trained in K9 dog center for a period of 6-8 weeks to give a behavior response to positive samples. During training the reaction of each dog to a positive sample will be observed (i.e. standing, sitting or lying down) and this indicating behaviour reinforced by rewarding the dog. The dog's diagnostic accuracy will then be determined in a double-blinded study. Here the trainer and technician using the computer to record the results of the study are blinded to the identity of each sample until the trainer calls the final decision (positive or negative) based on the response of the dog to the sample.
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 10 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Riadh Boukef, professor principal investigator
CHU Sahloul, Sousse, Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collection of odour samples in people with COVID-19, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
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 4 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 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. 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?
Sensitivity and specificity precision of dogs to detect people with COVID-19 by their odour. (time frame: 1 months). 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 10 Apr 2023.