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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05205655
Other study ID # CovDog
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date August 31, 2021

Study information

Verified date April 2023
Source Hôpital Universitaire Sahloul
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Canine olfactive detection has proven its efficacy in numerous situations (explosives, drugs, bank notes…) including for early diagnosis of human diseases: various cancers, alert of diabetic or epileptic people in immediate alarm of crisis.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
collection of odour samples
Odours will be collected by participants by putting sterile compresses under the armpits for at least 4 h.

Locations

Country Name City State
Tunisia Riadh Boukef Sahloul Sousse

Sponsors (1)

Lead Sponsor Collaborator
Hôpital Universitaire Sahloul

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity precision of dogs to detect people with COVID-19 by their odour. 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
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