Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04509713
Status:
UNKNOWN
Last Update Posted:
2020-08-12
First Post:
2020-08-06
Brief Title:
Canine COVID-19 Detection
Sponsor:
ARCTEC
Organization:
ARCTEC
Study Overview
Official Title:
Using Medical-detection Dogs to Identify People With SARS-CoV- Phase I Proof-of-concept Studies
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dogs are some of natures 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 dont 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 ie 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 andor 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
COVID-19 can present itself asymptomatically ie 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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None