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

COVID-19 Clinical Trial

Official title:

Clinical Validation of Biosafety Technologies Breath Analyser Tests for the Diagnosis of COVID-19; the Project Aims to Validate the Diagnostic Device and to Assess the Comparative Performance With RT-PCR Currently Being Deployed in the NHS.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05094674
• Other study ID #: BREATHE
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: October 2021
• Source: Tera Group
• Contact: Rebecca Roberts
• Phone: 0161 922 4451
• Email: rebecca.roberts[@]tgh.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Within this proposed project, the NHS will collect two diagnostic or screening tests per participant. One sample will be used by NHS and be run through regular diagnostics. The second, will be breath sample which will be tested using the BioSafety Technologies Ltd, rapid screening tool. This will use a pre-defined protocol. These tests would then be compared to assess the diagnostic efficacy including sensitivity and specificities. We will be aiming to achieve a significant comparison to ensure certainty and to exploit the information for proposing a novel diagnostic system to enhance capabilities to scale up the testing of patients. The proposed activity involves clinical validation of BioSafety Testing, to enhance the performance of detection along with clinicians.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 30, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subjects under general anaesthesia

• The inability to personally sign the consent form.

• The inability to exhale breath

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Breath Sample analysis
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.

Locations

Country	Name	City	State
United Kingdom	Tameside and Glossop Integrated Care NHS	Ashton Under Lyne	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
Tera Group

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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