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Detection Dogs as a Help in the Detection of COVID-19 (COVDOG)

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
collection of odour samples
Sponsored by
Hôpital Universitaire Sahloul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for COVID-19 focused on measuring Biomedical detection dogs; Olfaction; Olfactory sense; Screening method; Sniffer dogs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Due to have a coronavirus swab test or have had a swab test conducted in the previous 24 hours Aged ≥ 18 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 put a steril compresses for at least 4 h

Exclusion Criteria:

Aged < 18 years Written informed consent not provided Unable or unwilling to put a compresses for at least 4 h

Sites / Locations

  • Riadh Boukef

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

positive group

negative group

Arm Description

asymptomatic or mildly symptomatic participants positive for SARS-CoV-2 RNA

no evidence of SARS-CoV-2 by real-time RT-PCR

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 23, 2022
Last Updated
April 6, 2023
Sponsor
Hôpital Universitaire Sahloul
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1. Study Identification

Unique Protocol Identification Number
NCT05205655
Brief Title
Detection Dogs as a Help in the Detection of COVID-19
Acronym
COVDOG
Official Title
Canine Olfactory Detection and Its Relevance for the Medical Identification of Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Universitaire Sahloul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Biomedical detection dogs; Olfaction; Olfactory sense; Screening method; Sniffer dogs

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
positive group
Arm Type
Active Comparator
Arm Description
asymptomatic or mildly symptomatic participants positive for SARS-CoV-2 RNA
Arm Title
negative group
Arm Type
Experimental
Arm Description
no evidence of SARS-CoV-2 by real-time RT-PCR
Intervention Type
Behavioral
Intervention Name(s)
collection of odour samples
Intervention Description
Odours will be collected by participants by putting sterile compresses under the armpits for at least 4 h.
Primary Outcome Measure Information:
Title
Sensitivity and specificity precision of dogs to detect people with COVID-19 by their odour.
Description
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.
Time Frame
1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riadh Boukef, professor
Organizational Affiliation
CHU Sahloul, Sousse, Tunisia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riadh Boukef
City
Sahloul
State/Province
Sousse
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Detection Dogs as a Help in the Detection of COVID-19

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