Canine COVID-19 Detection Phase 2 and 3
LSH1394
Using Medical-detection Dogs to Identify People With SARS-CoV-2. Phase 2 and 3 -Training Dogs to Detect People Infected With SARS-CoV-2.
1 other identifier
observational
11,015
1 country
1
Brief Summary
The purpose of this study is to determine whether trained medical detection dogs can accurately detect the presence of COVID-19 in people infected with the virus, or using samples of their clothing or body odour. The study will train dogs to identify and discriminate between individuals wearing clothing collected from people infected with SARS-CoV-2 and uninfected individuals under semi-field conditions.Following this training, field testing will be used to determine whether trained dogs can distinguish between people infected with SARS-CoV-2 and uninfected individuals, producing estimates of dogs' sensitivity and specificity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2021
CompletedFirst Submitted
Initial submission to the registry
June 28, 2021
CompletedFirst Posted
Study publicly available on registry
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2021
CompletedJuly 30, 2021
July 1, 2021
6 months
June 28, 2021
July 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Phase 2: Sensitivity of dogs detecting COVID-19 on worn clothing samples.
The phase 2 study section is designed to measure the sensitivity of the dogs to detect participants infected with SARS-CoV-2 using clothing samples. During testing the reaction of each dog to a positive sample will be observed (i.e. standing, sitting or lying down). 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. This outcome will assess dogs' sensitivity in screening clothing samples collected in an earlier trial, and worn by volunteers, all of whom are expected to be SARS-CoV-2 negative. Sensitivity will be calculated against 'gold standard' of RT-PCR test outcomes.
6 weeks
Phase 2: Specificity of dogs detecting COVID-19 on worn clothing samples.
The phase 2 study section is designed to measure the specificity of the dogs to detect participants infected with SARS-CoV-2 using clothing samples. During testing the reaction of each dog to a positive sample will be observed (i.e. standing, sitting or lying down). 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. This outcome will assess dogs' specificity in screening clothing samples collected in an earlier trial, and worn by volunteers, all of whom are expected to be SARS-CoV-2 negative. Specificity will be calculated against 'gold standard' of RT-PCR test outcomes.
6 weeks
Phase 3: Specificity precision of dogs to detect COVID-19 in humans in semi-field settings.
The phase 3 study section will measure the sensitivity of the dogs in detection of SARS-CoV-2 on human participants in semi-field settings. During screening the reaction of each dog to an individual being screened will be observed (i.e. standing, sitting or lying down). The dog's diagnostic sensitivity will be calculated by comparing these indications against outcomes of RT-PCR tests, which must be conducted within 96 hours of test participation. Testing will be conducted under double-blinded conditions. This outcome will assess dogs' sensitivity on in-person volunteers, screened in semi-field settings. Volunteers will comprise both SARS-CoV-2 positive and SARS-CoV-2 negative individuals. Sensitivity will be calculated to +/- 5% accuracy. Sensitivity= percentage of true positives correctly identified by dogs.
20 weeks (overlapping with phase 2)
Phase 3: Specificity precision of dogs to detect COVID-19 in humans in semi-field settings.
The phase 3 study section will measure the specificity of the dogs in detection of SARS-CoV-2 on human participants in semi-field settings. During screening the reaction of each dog to an individual being screened will be observed (i.e. standing, sitting or lying down). The dog's diagnostic specificity will be calculated by comparing these indications against outcomes of RT-PCR tests, which must be conducted within 96 hours of test participation. Testing will be conducted under double-blinded conditions. This outcome will assess dogs' specificity on in-person volunteers, screened in semi-field settings. Volunteers will comprise both SARS-CoV-2 positive and SARS-CoV-2 negative individuals. Specificity will be calculated to +/- 5% accuracy. Specificity= percentage of true negatives correctly identified by dogs.
20 weeks (overlapping with phase 2)
Secondary Outcomes (1)
Qualitative outcome: acceptability of dogs as a screening tool
8 weeks
Study Arms (2)
SARS-CoV-2 Infected/ positive group
Has tested positive for SARS-CoV-2 within appropriate timeframe (criteria vary for different study stages). Aged 16 years or older, willing and able to provide informed consent.
SARS-CoV-2 negative group
Has tested negative for SARS-CoV-2 within appropriate timeframe (criteria vary for different study stages, and in phase 2 part 1, 2 and 4 enrolment may be accepted using symptoms-based criteria). Aged 16 years or older, willing and able to provide informed consent.
Interventions
Participants will be screened by medical detection dogs. In phase 2, participants may be asked to wear clothing samples collected in phase 1, as part of dog training procedures. In subsequent study parts, participants will wear their own clothing.
Eligibility Criteria
Phase 2 parts 1 and 2: Study population will comprise SARS-CoV-2 negative volunteers. Phase 2 part 3: Study population will comprise SARS-CoV-2 positive volunteers living locally to Milton Keynes. Phase 2 part 4: Study population will comprise attendees or passengers at relevant field location. Phase 2 part 5: Study population will consist of stakeholders appropriate to the field location used in phase 2 part 4. Phase 3: Volunteers who are seeking testing for COVID-19, or who have been tested in the past 4 days.
You may qualify if:
- Phase 2, training part 1 \& 2
- Adult male or female, aged 16 years or over.
- Written (hard copy or electronic) or verbal informed consent provided.
- Willing and able to wear or carry clothing (e.g. t-shirt) collected as part of Phase 1 from an individual infected with SARS-CoV-2 or an individual not infected with SARS-CoV-2.
- Has declared non-symptomatic 7 days (as defined by the latest NHS guidance) prior to participation in the training exercise.
- Would be willing to have a SARS-CoV-2 test within 24 h of the training exercise if required.
- Phase 2, training part 3
- Adult male or female, aged 16 years or over.
- Written (hard copy or electronic) or verbal informed consent provided.
- Has received a positive result for SARS-CoV-2 from a test conducted within the past 5 days. or is experiencing SARS-CoV-2 symptoms.
- Willing and able to share, or grant access to, their SARS-CoV-2 test result.
- Has access to private outdoor space (e.g. front garden, driveway), reachable without leaving the location where the participant is self-isolating.
- Is asymptomatic or mildly ill (i.e. not requiring hospitalisation, able to walk short distances and stand for up to 15 minutes).
- Phase 2 part 4, acceptability and feasibility study
- Adult male or female, aged 16 years or over.
- +15 more criteria
You may not qualify if:
- Phase 2, training part 1 \& 2
- Younger than 16 years old
- Informed consent not provided
- Unwilling or unable to wear or carry clothing from an individual infected or uninfected with SARS-CoV-2.
- Has not declared non-symptomatic within 7 days prior to the training exercise.
- Is unwilling or unable to have a SARS-CoV-2 test within 24 hours of the training exercise if required.
- Phase 2, training part 3
- Adult male or female, aged under 16 years.
- Informed consent not provided.
- Has not received a positive result for SARS-CoV-2 or experiencing SARS-CoV-2 symptoms.
- Unwilling or unable to share, or grant access to their SARS-CoV-2 test result.
- Has no access to private outdoor space.
- Participant requires hospitalisation or is unable to walk short distances and stand for up to 15 minutes.
- Phase 2 part 4, acceptability and feasibility study
- Adult male or female, aged under 16 years.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ARCTEClead
- Durham Universitycollaborator
- Cardiff Universitycollaborator
- Medical Detection Dogscollaborator
Study Sites (1)
Arctec at London School of Hygiene & Tropical Medicine
London, WC1E 7HT, United Kingdom
Biospecimen
Odour swab samples may be collected and retained as part of this study. These samples will comprise human sweat, and will not be used for DNA analysis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2021
First Posted
July 1, 2021
Study Start
March 8, 2021
Primary Completion
August 30, 2021
Study Completion
September 27, 2021
Last Updated
July 30, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share