Covid19NCT04509713
Canine COVID-19 Detection
An observational study of Covid19, run by ARCTEC at 1 site in United Kingdom.
Trial summary
Dogs are some of nature's greatest detectives, owing to their incredible sense of smell and ability to be trained. Most of us will be familiar with seeing trained sniffer dogs at airports looking for drugs and other prohibited items, but their skills don't stop there. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Collection of odour samples
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16,250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jul 2020to 31 Oct 2020
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Have suspected mild COVID-19 symptoms or have been exposed to COVID-19, or are NHS staff or household member of NHS staff
Who may be able to join
- Due to have a coronavirus swab test or have had a swab test conducted in the previous 24 hours
- Aged ≥ 16 years
- Have suspected mild COVID-19 symptoms or have been exposed to COVID-19, or are NHS staff or household member of NHS staff
- No evidence of previous laboratory confirmed SARS-CoV-2
- Written informed consent provided
- Willing and able to wear a face mask for at least 3h
Show all 9Show fewer
- Willing and able to wear nylon socks for at least 12 h
- Willing and able to wear a shirt for at least 12 h
- Willing and able to provide a copy of their coronavirus swab test result
Who cannot join
- Aged < 16 years
- Evidence of moderate to severe illness with symptoms compatible with SARS-CoV-2 infection which require hospital admission
- Previous (>24 hours) clinical diagnosis of COVID-19
- Previous (>24 hours) laboratory confirmed SARS-CoV-2 infection
- Written informed consent not provided
- Unable or unwilling to wear a facemask for at least 3 h
Show all 9Show fewer
- Unwilling or unable to wear nylon socks for at least 12 h
- Unwilling or unable to wear a shirt for at least 12 h
- Unwilling or unable to provide a copy of their coronavirus swab test result
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
ARCTEC
London, WC1E 7HT
James Logan, PHD, +44 (0) 20 7927 2008, James.Logan@lshtm.ac.uk
About this study
Official title: Using Medical-detection Dogs to Identify People With SARS-CoV-: Phase I: Proof-of-concept Studies
Dogs are some of nature's greatest detectives, owing to their incredible sense of smell and ability to be trained. Most of us will be familiar with seeing trained sniffer dogs at airports looking for drugs and other prohibited items, but their skills don't stop there. The use of medical detection dogs is becoming increasingly common, as they are able to identify cancers, changes in blood sugar levels and even predict seizures. These are just a few examples of dogs playing a key role in public health. Many diseases can alter the way humans smell. A study undertaken by the London School of Hygiene \& Tropical Medicine (LSHTM) and Durham University has shown that dogs are able to accurately diagnose malaria. The investigators know that respiratory illnesses can alter your body odours, and thus the investigators plan to determine whether dogs are able to identify the novel coronavirus known as COVID-19 (or SARS-CoV-2).
COVID-19 can present itself asymptomatically (i.e. causing no apparent symptoms), which could lead to the spread of infection in the population. The investigators believe that dogs may be able to identify asymptomatic patients, as well as those who have mild symptoms (symptoms not requiring treatment, hospital stay or limiting normal activities). It is thought that a single medical detection dog stationed within an airport would be able to screen up to 750 people for COVID-19 infection in just 1 hour, informing those who are infected to isolate, preventing further spread of the disease.
Read more
In order to determine whether it is possible for dogs to accurately diagnose COVID-19, the investigators must first collect samples. NHS staff and members of their households that are eligible for SARS-CoV-2 screening, have been selected to participate in this study due to their potential exposure to this disease agent. In addition, participants from the general population who are displaying mild COVID-19 symptoms or have been exposed to COVID-19 will be recruited via hospitals, testing centers, outbreak testing programs and home testing programs. Initially, participants will attend their screening test as planned or confirm that they have had a swab test within the previous 24 hours. Immediately following this, the investigators will ask participants to collect samples of breath odour and body odour, which will be collected passively through the wearing of face masks, shirts, and nylon socks. The investigators will ask to be provided with the results of the SARS-CoV-2 screening swab, which will allow for us to determine whether participants are positive or negative for SARS-CoV-2. These odour samples will be grouped by positive or negative test results, and transported to LSHTM where these will be processed in order to prevent contact with the virus, negating the risk for dogs and their handlers.
A pilot study will be undertaken to confirm whether dogs are able to distinguish between positive and negative samples using traditional sniffer dog training methods. If this is possible, the investigators will proceed to the main study to determine the accuracy (known as sensitivity and specificity) of the dogs' ability to identify the virus. Both the handler and the dogs themselves will be 'blinded' to the samples, and thus unaware of which sample is which. When the data generated by these tests is entered, it will be confirmed whether or not the samples have been correctly identified.
The dogs will be trained to detect and report the detection of the volatile odours characteristic of COVID-19 infection. For quality control purposes the investigators also aim to characterise the COVID-19 odour profile by analysing samples with a special process called GC (gas chromatography) and/or GC-MS (gas chromatography coupled mass spectrometry). This will help to inform the identification of compounds showing differences between infected and non-infected samples.
The investigators believe that this work could be useful in the fight against COVID-19.
- Conditions
- Covid19
- Being tested
- Collection of odour samples
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of odour samplesBehavioural
Samples of breath odours will be passively collected while participants wear the mask while breathing naturally, for at least 3 h. Skin odours will be passively collected by participants wearing the shirt and nylon socks for at least 12 h.
| Study group | Role | What they receive |
|---|---|---|
| infected/positive group | asymptomatic or mildly symptomatic participants positive for SARS-CoV-2 RNA Receives: Behavioral: Collection of odour samples | |
| uninfected/negative group | 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 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: 4 months
Secondary outcomes (1)
Identification of the volatile profile that is specific to asymptomatic or mild symptomatic participants with SARS-CoV-2 compared with uninfected individuals.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start2 Jul 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 16,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARCTEC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Durham University, Cardiff University, Medical Detection Dogs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509713
- Sponsor's protocol ID
- LSH1285
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guest C, Dewhirst SY, Lindsay SW, Allen DJ, Aziz S, Baerenbold O, Bradley J, Chabildas U, Chen-Hussey V, Clifford S, Cottis L, Dennehy J, Foley E, Gezan SA, Gibson T, Greaves CK, Kleinschmidt I, Lambert S, Last A, Morant S, Parker JEA, Pickett J, Quilty BJ, Rooney A, Shah M, Somerville M, Squires C, Walker M, Logan JG; COVID Dogs Research Team. Using trained dogs and organic semi-conducting sensors to identify asymptomatic and mild SARS-CoV-2 infections: an observational study. J Travel Med. 2022 May 31;29(3):taac043. doi: 10.1093/jtm/taac043.
PubMed 35325195
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Medical-detection Dogs to Identify People With SARS-CoV-: Phase I: Proof-of-concept Studies
- ClinicalTrials.gov ID
- NCT04509713
- Acronym / sponsor ID
- LSH1285
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16,250 participants (estimated)
- Lead sponsor
- ARCTECIndustry (pharma, biotech, devices)
- Collaborators
- Durham University, Cardiff University, Medical Detection Dogs
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 12 Aug 2020 (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.
Dogs are some of nature's greatest detectives, owing to their incredible sense of smell and ability to be trained. Most of us will be familiar with seeing trained sniffer dogs at airports looking for drugs and other prohibited items, but their skills don't stop there. The use of medical detection dogs is becoming increasingly common, as they are able to identify cancers, changes in blood sugar levels and even predict seizures. These are just a few examples of dogs playing a key role in public health. Many diseases can alter the way humans smell. A study undertaken by the London School of Hygiene \& Tropical Medicine (LSHTM) and Durham University has shown that dogs are able to accurately diagnose malaria. The investigators know that respiratory illnesses can alter your body odours, and thus the investigators plan to determine whether dogs are able to identify the novel coronavirus known as COVID-19 (or SARS-CoV-2).
COVID-19 can present itself asymptomatically (i.e. causing no apparent symptoms), which could lead to the spread of infection in the population. The investigators believe that dogs may be able to identify asymptomatic patients, as well as those who have mild symptoms (symptoms not requiring treatment, hospital stay or limiting normal activities). It is thought that a single medical detection dog stationed within an airport would be able to screen up to 750 people for COVID-19 infection in just 1 hour, informing those who are infected to isolate, preventing further spread of the disease.
In order to determine whether it is possible for dogs to accurately diagnose COVID-19, the investigators must first collect samples. NHS staff and members of their households that are eligible for SARS-CoV-2 screening, have been selected to participate in this study due to their potential exposure to this disease agent. In addition, participants from the general population who are displaying mild COVID-19 symptoms or have been exposed to COVID-19 will be recruited via hospitals, testing centers, outbreak testing programs and home testing programs. Initially, participants will attend their screening test as planned or confirm that they have had a swab test within the previous 24 hours. Immediately following this, the investigators will ask participants to collect samples of breath odour and body odour, which will be collected passively through the wearing of face masks, shirts, and nylon socks. The investigators will ask to be provided with the results of the SARS-CoV-2 screening swab, which will allow for us to determine whether participants are positive or negative for SARS-CoV-2. These odour samples will be grouped by positive or negative test results, and transported to LSHTM where these will be processed in order to prevent contact with the virus, negating the risk for dogs and their handlers.
A pilot study will be undertaken to confirm whether dogs are able to distinguish between positive and negative samples using traditional sniffer dog training methods. If this is possible, the investigators will proceed to the main study to determine the accuracy (known as sensitivity and specificity) of the dogs' ability to identify the virus. Both the handler and the dogs themselves will be 'blinded' to the samples, and thus unaware of which sample is which. When the data generated by these tests is entered, it will be confirmed whether or not the samples have been correctly identified.
The dogs will be trained to detect and report the detection of the volatile odours characteristic of COVID-19 infection. For quality control purposes the investigators also aim to characterise the COVID-19 odour profile by analysing samples with a special process called GC (gas chromatography) and/or GC-MS (gas chromatography coupled mass spectrometry). This will help to inform the identification of compounds showing differences between infected and non-infected samples.
The investigators believe that this work could be useful in the fight against COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infected/positive group | – | Behavioral: Collection of odour samplesasymptomatic or mildly symptomatic participants positive for SARS-CoV-2 RNA |
| uninfected/negative group | – | Behavioral: Collection of odour samplesno evidence of SARS-CoV-2 by real-time RT-PCR |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Have suspected mild COVID-19 symptoms or have been exposed to COVID-19, or are NHS staff or household member of NHS staff
Key inclusion criteria (9 listed)
- Due to have a coronavirus swab test or have had a swab test conducted in the previous 24 hours
- Aged ≥ 16 years
- Have suspected mild COVID-19 symptoms or have been exposed to COVID-19, or are NHS staff or household member of NHS staff
- No evidence of previous laboratory confirmed SARS-CoV-2
- Written informed consent provided
Key exclusion criteria (9 listed)
- Aged < 16 years
- Evidence of moderate to severe illness with symptoms compatible with SARS-CoV-2 infection which require hospital admission
- Previous (>24 hours) clinical diagnosis of COVID-19
- Previous (>24 hours) laboratory confirmed SARS-CoV-2 infection
- Written informed consent not provided
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 samplesSamples of breath odours will be passively collected while participants wear the mask while breathing naturally, for at least 3 h. Skin odours will be passively collected by participants wearing the shirt and nylon socks for at least 12 h. | Behavioural | infected/positive group, uninfected/negative group |
Primary outcome
Sensitivity and specificity precision of dogs to detect people with COVID-19 by their odour.
Time frame: 4 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 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.
1 secondary outcome
Identification of the volatile profile that is specific to asymptomatic or mild symptomatic participants with SARS-CoV-2 compared with uninfected individuals.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Derived from this study: PubMed 35325195Guest C, Dewhirst SY, Lindsay SW, Allen DJ, Aziz S, Baerenbold O, Bradley J, Chabildas U, Chen-Hussey V, Clifford S, Cottis L, Dennehy J, Foley E, Gezan SA, Gibson T, Greaves CK, Kleinschmidt I, Lambert S, Last A, Morant S, Parker JEA, Pickett J, Quilty BJ, Rooney A, Shah M, Somerville M, Squires C, Walker M, Logan JG; COVID Dogs Research Team. Using trained dogs and organic semi-conducting sensors to identify asymptomatic and mild SARS-CoV-2 infections: an observational study. J Travel Med. 2022 May 31;29(3):taac043. doi: 10.1093/jtm/taac043.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by ARCTEC at 1 site in United Kingdom.
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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Aug 2020. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509713, which also lists 1 linked publication.
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 12 Aug 2020.