NCT04948190

Canine COVID-19 Detection Phase 2 and 3

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 11,015 (estimated)
• Sponsor: ARCTEC · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Detailed description

When the COVID-19 epidemic wanes it will be important to prevent outbreaks of, and the reintroduction of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) into the country, since there will be many susceptible individuals remaining in the population. In order to prevent third and further waves of COVID-19, it will be important to screen passengers arriving from high-risk countries. This task would be made simpler if a rapid non-invasive method were available for detecting infected individuals, particularly those with asymptomatic, pre-symptomatic or prodromal symptomatic infections with SARS-CoV-2 from those individuals who are not carrying the virus. Thermal screening, practised in many airports and ports around the world, has a low sensitivity since not all patients develop fever. Consequently, it has received considerable criticism in some quarters. The use of trained dogs could provide a rapid primary screen for detecting those potentially carrying the SARS-CoV-2 virus. Travellers indicated by the dogs as likely to be carrying the virus would then be tested by nasal and throat swabs, with diagnosis confirmed/excluded using real-time RT-PCR or an accurate rapid diagnostic test according to Government Guidelines. Using trained dogs would enable extremely rapid screening, with each dog able to assess up to 250 travellers per hour, saving time and money. There is evidence that viral and bacterial respiratory infections cause the release of specific odours from human cells. Other work with detection dogs has found dogs can detect and learn the smell of virus-associated volatiles in real time, with sensitivities of up to 96% and specificity of up to 98%. The current study will build further investigate whether trained dogs can differentiate between odours associated with viral infections. In Phase 1 of this study (Clinical Trials ref: NCT04509713), the investigators hypothesised that dogs, with their highly advanced sense of smell could be trained to detect people infected with the SARS-CoV-2 virus. Medical Detection Dogs were trained and tested using stand trials with clothing samples worn by people who had variously tested positive or negative for SARS-CoV-2 in RT-PCR tests. In Phase 2, the clothing collected in Phase 1 will be used to train and transition the dogs from Phase 1, where they identified samples in the laboratory environment, to semi-field settings. Phase 1 clothing samples will be worn by human volunteers in a series of 'line-up' trials, under increasingly complex settings. As part of phase 2, study staff will opportunistically conduct line-up tests with volunteers confirmed to be infected with SARS-CoV-2, to allow dogs to learn the whole-body odour of infection. Phase 3 will take place once the investigators have demonstrated the dogs can work within a real-world environment (Phase 2 above). In this phase, trainers will deploy the dogs and evaluate performance through in use testing. This will be done at a suitable venue, most likely a COVID-19 testing centre, airport or university, to ensure a high enough rate of potential positive individuals.

Conditions

• Covid19
• SARS-CoV2 Infection

Interventions

Type	Name	Description
BEHAVIORAL	Testing with medical detection dogs	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.

Timeline

• Start date: 2021-03-08
• Primary completion: 2021-08-30
• Completion: 2021-09-27
• First posted: 2021-07-01
• Last updated: 2021-07-30

Locations

1 site across 1 country: United Kingdom