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

NCT05205655 | Completed

• 1 other identifier: CovDog
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Biomedical detection dogs; Olfaction; Olfactory sense; Screening method; Sniffer dogs

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

positive group

ACTIVE COMPARATOR

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

Behavioral: collection of odour samples

negative group

EXPERIMENTAL

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

Behavioral: collection of odour samples

Interventions

collection of odour samples BEHAVIORAL

Odours will be collected by participants by putting sterile compresses under the armpits for at least 4 h.

negative group; positive group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital Universitaire Sahloul: lead

Study Sites (1)

Riadh Boukef

Sahloul, Sousse Governorate, Tunisia

Location

MeSH Terms

Conditions

COVID-19; Anosmia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Riadh Boukef, professor

  CHU Sahloul, Sousse, Tunisia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: January 25, 2022
• Study Start: March 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)