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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Behavioral: collection of odour samples

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: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Sousse
    • Sahloul, Sousse, Tunisia
      • Riadh Boukef

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: positive group; asymptomatic or mildly symptomatic participants positive for SARS-CoV-2 RNA	Behavioral: collection of odour samples; 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	Behavioral: collection of odour samples; 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.	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: Hôpital Universitaire Sahloul

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: January 23, 2022
• First Submitted That Met QC Criteria: January 23, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Biomedical detection dogs; Olfaction; Olfactory sense; Screening method; Sniffer dogs
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CovDog

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No