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

October 24, 2021 updated by: Tera Group

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.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

500

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 Contact

Study Locations

  • United Kingdom
    • Lancashire
      • Ashton Under Lyne, Lancashire, United Kingdom, OL6 9RW
        • Recruiting
        • Tameside and Glossop Integrated Care NHS
        • Contact:

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Participants who require a diagnostic or screening COVID-19 RT-PCR test
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Tera Group

Investigators

  • Principal Investigator: Ilan Lieberman, MD, Tameside and Glossop Integrated Care NHS England

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)

October 22, 2021

Primary Completion (ANTICIPATED)

June 22, 2022

Study Completion (ANTICIPATED)

July 30, 2022

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

October 24, 2021

First Posted (ACTUAL)

October 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 24, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BREATHE

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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