The performance of a novel ultra-rapid diagnostic test in the detection of COVID 19, an observational and case controlled study.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/11/029037
- Lead Sponsor
- Canary Health Technologies
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Participant is willing and able to give informed consent for participation in the study.
Male or Female, Adult over the age of 18
No smoking, eating or alcohol for 4 hours prior to test
Either COVID-19 Positive or COVID-19 Negative
No perfume/cologne or heavy scent
Subject who is able to comply with the study requirements, as defined in the present protocol, at the Investigatorâ??s discretion
Able (in the Investigators opinion) and willing to comply with all study requirements.
Diagnosed with required disease/severity/symptoms, or, if healthy volunteer study: beingood health
Age <14
Any serious injury or illness likely to preclude completion of the trial.
Frequent alcohol or recreational drug use.
Hospitalized.
Undergoing active chemotherapy.
Fever in uninfected controls.
Hypoxia, defined as pulse oximetry lower than 92% (90% in smokers and those with
chronic lung disease).
Respiratory disease such as COPD and Asthma.
Currently taking any corticosteroid treatment including but not limited to oral and inhaled
corticosteroid (within 4 weeks of trial).
Inability to give informed consent and/or has no guardian.
Flu shot within 6-8 weeks of test.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To collect breath sample from uninfected subjects and those diagnosed with COVID 19 and compare the VOC pattern in each group to develop an algorithm for analysisTimepoint: At the end of the Study
- Secondary Outcome Measures
Name Time Method To test the large group of COVID 19 positive and negative patients to develop the AI pattern-recognition program and to ascertain the test characteristics of the deviceTimepoint: At the end of the study