- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05205655
Detection Dogs as a Help in the Detection of COVID-19 (COVDOG)
Canine Olfactory Detection and Its Relevance for the Medical Identification of Patients With COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Fighting such a viral outbreak requires a widespread testing, one of the key measures for tackling the pandemic. In June 2020, facing a decline of COVID-19, it is possible to say that countries that have mastered their outbreak, and were able to maintain the number of infected people low, need to perform fewer test to correctly monitor the outbreak, than those countries where the virus has spread more widely. And for the same reasons, the timing of testing is also crucial. A high rate of testing will be way more effective to slow an outbreak if conducted earlier on, at a time when there is fewer infectious
The aim of this study is to evaluate if the sweat produced by COVID-19 persons (SARS-CoV-2 PCR positive) has a different odour for trained detection dogs than the sweat produced by non COVID-19 persons. The study was conducted on 3 sites, following the same protocol procedures, and involved a total of 18 dogs. A total of 198 armpits sweat samples were obtained from different hospitals. For each involved dog, the acquisition of the specific odour of COVID-19 sweat samples required from one to four hours, with an amount of positive samples sniffing ranging from four to ten.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sousse
-
Sahloul, Sousse, Tunisia
- Riadh Boukef
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Due to have a coronavirus swab test in the previous 24 hours
- Aged ≥ 18 years
- Suspected mild COVID-19 symptoms or have been exposed to COVID-19
- Written informed consent provided
Exclusion Criteria:
- Aged < 18 years
- Written informed consent not provided
- Unable or unwilling to put a compresses for at least 4 h
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: positive group
asymptomatic or mildly symptomatic participants positive for SARS-CoV-2 RNA
|
Odours will be collected by participants by putting sterile compresses under the armpits for at least 4 h.
|
|
Experimental: negative group
no evidence of SARS-CoV-2 by real-time RT-PCR
|
Odours will be collected by participants by putting sterile compresses under the armpits for at least 4 h.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity and specificity precision of dogs to detect people with COVID-19 by their odour.
Time Frame: 1 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 in K9 dog center 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 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CovDog
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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