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

NCT ID: NCT05094674

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-22

Study Completion Date

2022-07-30

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Breath Sample analysis

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tera Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilan Lieberman, MD

Role: PRINCIPAL_INVESTIGATOR

Tameside and Glossop Integrated Care NHS England

Locations

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Tameside and Glossop Integrated Care NHS

Ashton-under-Lyne, Lancashire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Rebecca Roberts

Role: CONTACT

Phone: 0161 922 4451

Email: [email protected]

Facility Contacts

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Rebecca Roberts

Role: primary

Other Identifiers

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BREATHE

Identifier Type: -

Identifier Source: org_study_id