Clinical Validation of Breath Analyser Tests for Diagnosis of COVID-19.

NCT05094674 | Unknown

• 1 other identifier: BREATHE
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The Sponsor has developed a rapid screening tool intended to determine if the subject tested is COVID-19-free (Negative to COVID-19).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Rate of positive and negative cases in collected breath samples using breath analyser test.

  The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample

Study Arms (1)

Participants who require a diagnostic or screening COVID-19 RT-PCR test

OTHER

Participants who require a diagnostic or screening COVID-19 RT-PCR test, presenting at Tameside and Glossop Integrated Care NHS Foundation Trust aged 18 years or over

Diagnostic Test: Breath Sample analysis

Interventions

Breath Sample analysis DIAGNOSTIC_TEST

The participant's breath sample is taken by blowing preferably three times into a disposable tube. Thereafter, the tube is sealed, sterilized, and scanned by the BioSafety Station for analysis. This will take place once during the study.

Participants who require a diagnostic or screening COVID-19 RT-PCR test

Eligibility Criteria

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

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Requiring a diagnostic or screening RT-PCR test for COVID-19

You may not qualify if:

• Subjects under general anaesthesia
• The inability to personally sign the consent form.
• The inability to exhale breath

Sponsors & Collaborators

• Tera Group: lead

Study Sites (1)

Tameside and Glossop Integrated Care NHS

Ashton-under-Lyne, Lancashire, OL6 9RW, United Kingdom

RECRUITING

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Ilan Lieberman, MD

  Tameside and Glossop Integrated Care NHS England

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Roberts

CONTACT

0161 922 4451; rebecca.roberts@tgh.nhs.uk

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: The participant's breath sample is taken by blowing preferably three times into a disposable TeraTube. Thereafter, the tube is sealed, sterilized, and scanned by the BioSafety Station for analysis of its bio-chemical spectral signature. This will take place once during the study.

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: October 26, 2021
• Study Start: October 22, 2021
• Primary Completion: June 22, 2022
• Study Completion: July 30, 2022
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)