Clinical trial NCT04459962: Covid-19 Breath Test
Official title: Breath Test Feasibility Trial for Covid-19 Infection Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19 Infection
Lead sponsor: Ancon Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 330
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants who are Covid-19 negative, Covid-19 positive or suspected with Covid-19 infection will be recruited
Primary purpose: DIAGNOSTIC

Brief summary: Can Nanotechnology Biomarker Tagging (NBT) be used to detect COVID-19 infection in people presenting for COVID-19 testing?

NBT can be used to detect the substances present in a person's breath. In this study the breath of people presenting for COVID-19 testing is going to be analysed. Analysing a large number of samples from people with COVID-19 (as confirmed by the standard swab test used by the NHS) will enable a breath profile to be produced, ie the substances present in the breath when someone has COVID-19. After the profile has been validated, NBT can be used to test whether or not a person has COVID-19 by seeing if their breath matches the profile.

Using this technology for COVID-19 testing has advantages over the current standard test. The sample can be analysed immediately in the clinical setting and the results are available in 5-10 minutes, so if the person tests negative they can go back to their normal life straight away. The current swab test takes around 72 hours for the results to be available, and the person needs to self-isolate during this time in case they test positive, resulting in potentially unnecessary days of work missed and inconvenience. The breath test is non-invasive and is unlikely to cause any discomfort, as the person is only required to breath normally into the device. This study will also review the practicalities of using this test. It is quick and easy to train people in how to carry out the test, so it could potentially easily be rolled out to testing sites.

Detailed description: This is a Cohort Study which will collect non-invasive, expired breath sample, cheek swab and a Medical and Lifestyle questionnaire from participants.

When the participant presents for COVID-19 testing they will be asked to provide a cheek swab and breath sample, and complete the study questionnaire. They will not need to give any identifiable information or have a second visit. The samples will be analysed immediately and disposed of as clinical waste. ANCON will then use the data to build a breath profile of COVID-19 infection.

Sample and data collection method for inpatients:

* Sequential (daily or every other day as able) breath and swab test will be taken from some of the patients admitted in the hospital (inpatients).
* This will be taken from entry or start of the study to discharge or end of study or until patient or medical staff deem unsuitable to continue
* This will enable to track infection and the relevant profile changes as covid-19 progresses and/or is treated. This will provide vital additional information around identifiers associated with the disease and its progress.

Anonymous Questionnaire - Each participant will be asked questions in the form of a short standard questionnaire based on:

* Medical Information
* Lifestyle Information

Eligibility criteria: Inclusion Criteria:

* Male \& Females.
* Age Above 16 years old
* All Ethnicity
* Any patients that come for COVID-19 testing
* COVID Negative Patients (Further participants may be selected as control groups who have no current diagnosis of COVID-19.)
* COVID Positive In-Patients

Exclusion Criteria:

* Outside of stated age range - below 16
* Unable to consent

Primary outcomes:
measure: To investigate/ examine the effectiveness of Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients with COVID-19 symptoms
timeFrame: 6 Months
Secondary outcomes:
measure: -To profile the unique pattern of Volatile Organic Compounds (VOCs) found in the expired breath of COVID-19 patients using the NBT system (VOC analysis and ML).
timeFrame: 6 months
measure: To differentiate this unique profile from the patients that are found to be negative for COVID-19
timeFrame: 6 months
Other outcomes:
Locations:
city: Chertsey
country: United Kingdom
facility: Ashford and St Peter's Hospitals NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Ashford and St Peter's Hospitals NHS Foundation Trust
name: Stephen Winchester, MBBS, MSc
role: PRINCIPAL_INVESTIGATOR
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