Clinical trial NCT04509713: Canine COVID-19 Detection
Official title: Using Medical-detection Dogs to Identify People With SARS-CoV-: Phase I: Proof-of-concept Studies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: ARCTEC
Sponsor class: INDUSTRY
Collaborators: name: Durham University
name: Cardiff University
name: Medical Detection Dogs
First posted: 2020-08-12
Enrollment: 16250
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Sensitivity and specificity precision of dogs to detect people with COVID-19 by their odour.
timeFrame: 4 months
Secondary outcomes:
measure: Identification of the volatile profile that is specific to asymptomatic or mild symptomatic participants with SARS-CoV-2 compared with uninfected individuals.
timeFrame: 4 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: ARCTEC
Study officials:
References:
citation: 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.