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临床试验/NCT05205655
NCT05205655已完成不适用

Canine Olfactory Detection and Its Relevance for the Medical Identification of Patients With COVID-19

Hôpital Universitaire Sahloul1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Sensitivity and specificity precision of dogs to detect people with COVID-19 by their odour.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Sensitivity and specificity precision of dogs to detect people with COVID-19 by their odour.

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Riadh Boukef

PROFESSOR

Hôpital Universitaire Sahloul

研究点 (1)

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