Covid-19 Breath Test

NCT04459962 | Completed

• 1 other identifier: 2020ATL01
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19 Infection

Outcome Measures

Primary Outcomes (1)

• To investigate/ examine the effectiveness of Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients with COVID-19 symptoms

  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 Outcomes (2)

• -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).

  6 months

• To differentiate this unique profile from the patients that are found to be negative for COVID-19

  6 months

Study Arms (1)

Study Arm

EXPERIMENTAL

Breath Test and Cheek Swab collection

Diagnostic Test: Breath Test & Cheek Swab

Interventions

Breath Test & Cheek Swab DIAGNOSTIC_TEST

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.

Study Arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ancon Technologies Ltd: lead

Study Sites (1)

Ashford and St Peter's Hospitals NHS Foundation Trust

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

Related Publications (10)

• Ajibola OA, Smith D, Spanel P, Ferns GA. Effects of dietary nutrients on volatile breath metabolites. J Nutr Sci. 2013 Oct 31;2:e34. doi: 10.1017/jns.2013.26. eCollection 2013.

  PMID: 25191584 BACKGROUND

• Smith D, Spanel P. The challenge of breath analysis for clinical diagnosis and therapeutic monitoring. Analyst. 2007 May;132(5):390-6. doi: 10.1039/b700542n. Epub 2007 Mar 19.

  PMID: 17471381 BACKGROUND

• Amann A, Spanel P, Smith D. Breath analysis: the approach towards clinical applications. Mini Rev Med Chem. 2007 Feb;7(2):115-29. doi: 10.2174/138955707779802606.

  PMID: 17305586 BACKGROUND

• Gouma PI, Wang L, Simon SR, Stanacevic M. Novel Isoprene Sensor for a Flu Virus Breath Monitor. Sensors (Basel). 2017 Jan 20;17(1):199. doi: 10.3390/s17010199.

  PMID: 28117692 BACKGROUND

• Kim, K.-H.Kim., Jahan, S.A., Kabir, E., (2012) A review of breath analysis for diagnosis of human health. TrAC Trends in Analytical Chemistry. v.33, 1-8. https://doi.org/10.1016/j.trac.2011.09.013

  BACKGROUND

• Lake MA. What we know so far: COVID-19 current clinical knowledge and research. Clin Med (Lond). 2020 Mar;20(2):124-127. doi: 10.7861/clinmed.2019-coron. Epub 2020 Mar 5.

  PMID: 32139372 BACKGROUND

• Marczin N, Kharitonov S (2003) Lung Biology in Health and Disease. Disease Markers in Exhaled Breath Edited by: New York: Marcel Dekker; 2003.

  BACKGROUND

• NHS-England, (2020) Guidance and standard operating procedure COVID-19 virus testing in NHS laboratories.

  BACKGROUND

• Sethi S, Nanda R, Chakraborty T. Clinical application of volatile organic compound analysis for detecting infectious diseases. Clin Microbiol Rev. 2013 Jul;26(3):462-75. doi: 10.1128/CMR.00020-13.

  PMID: 23824368 BACKGROUND

• Risby T., (2005): Current status of clinical breath analysis. In Breath Analysis for Clinical Diagnosis and Therapeutic Monitoring Edited by: Amann A, Smith D. Singapore: World Scientific; 2005:251-265.

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Breath Tests

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Stephen Winchester, MBBS, MSc

  Ashford and St Peter's Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants who are Covid-19 negative, Covid-19 positive or suspected with Covid-19 infection will be recruited

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 7, 2020
• Study Start: June 29, 2020
• Primary Completion: January 7, 2021
• Study Completion: January 7, 2021
• Last Updated: January 29, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)