Clinical Validation of Breath Analyser Tests for Diagnosis of COVID-19.
Primary Purpose
COVID-19
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Breath Sample analysis
Sponsored by

About this trial
This is an interventional diagnostic trial for COVID-19
Eligibility Criteria
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
Sites / Locations
- Tameside and Glossop Integrated Care NHSRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Participants who require a diagnostic or screening COVID-19 RT-PCR test
Arm Description
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
Outcomes
Primary Outcome Measures
Rate of positive and negative cases in collected breath samples using breath analyser test.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05094674
Brief Title
Clinical Validation of Breath Analyser Tests for Diagnosis of COVID-19.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
June 22, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tera Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants who require a diagnostic or screening COVID-19 RT-PCR test
Arm Type
Other
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Breath Sample analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of positive and negative cases in collected breath samples using breath analyser test.
Time Frame
The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Roberts
Phone
0161 922 4451
Email
rebecca.roberts@tgh.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilan Lieberman, MD
Organizational Affiliation
Tameside and Glossop Integrated Care NHS England
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tameside and Glossop Integrated Care NHS
City
Ashton Under Lyne
State/Province
Lancashire
ZIP/Postal Code
OL6 9RW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Roberts
Phone
0161 922 4451
Email
rebecca.roberts@tgh.nhs.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Validation of Breath Analyser Tests for Diagnosis of COVID-19.
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