Covid-19 Breath Test

January 28, 2021 updated by: Ancon Technologies Ltd

Breath Test Feasibility Trial for Covid-19 Infection Diagnosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT16 0PZ
        • Ashford and St Peter's Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Arm
Breath Test and Cheek Swab collection
Diagnostic test: Breath Test & Cheek Swab
Breath Sample and Cheek Swab of participants will be used for machine learning (NBT - Nanobiotechnology Biomarkers Tagging) system to develop a profile which can be used later on for Covid-19 Diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate/ examine the effectiveness of Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients with COVID-19 symptoms
Time Frame: 6 Months
This will be measured by identification of VOCs present in the breath sample of the COVID-19 positive and their relative concentrations compared to a COVID-19 negative breath sample. These will be combined to provide a COVID-19 positive profile
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
-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).
Time Frame: 6 months
This will be measured by identification of VOCs present in the breath sample of the COVID-19 positive and their relative concentrations compared to a COVID-19 negative breath sample using ML. These will be combined to provide a COVID-19 positive profile.
6 months
To differentiate this unique profile from the patients that are found to be negative for COVID-19
Time Frame: 6 months
The patient samples that return COVID-19 negative will be used as controls for identification of VOCs and relative concentrations that are common to all samples.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ancon Technologies Ltd

Investigators

  • Principal Investigator: Stephen Winchester, MBBS, MSc, Ashford and St Peter's Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2020

Primary Completion (Actual)

January 7, 2021

Study Completion (Actual)

January 7, 2021

Study Registration Dates

First Submitted

July 3, 2020

First Submitted That Met QC Criteria

July 3, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020ATL01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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