Performance Assessment of SARS-CoV-2 Detection Breath Biopsy - SARS-CoV-2 Study (COVID)

March 29, 2021 updated by: Owlstone Ltd

Performance Assessment of SARS-CoV-2 Detection Through Analysis of Exhaled Breath Aerosols

The primary aim of this study is to investigate the performance of Breath Biopsy RD for the detection of SARS-CoV-2 in both a clinical and at home setting.

Study Overview

Detailed Description

This study aims to evaluate Owlstone Medical's Breath Biopsy RD Collectors for the detection of SARS-CoV-2 infection. These single use disposable breath capture devices can be used independently by individuals and shipped to be analysed in a central lab for the presence of SARS-CoV-2 using established existing PCR assays available in any reference lab. The aerosol collectors furthermore directly sample exhaled breath aerosols. As such they directly sample the primary transmission route for the virus. This could result in a higher rate of retrieval of viral RNA in infected individuals thereby increasing the sensitivity of the applied PCR assay. This is underpinned by the fact that CT abnormalities in the lower airways appear to occur prior to upper respiratory tract samples becoming positive in cases suffering from nCOVID19, suggesting lower airway viral loads could be higher. Combined, this could enable more widespread access to diagnostics, reduce the need for repeat testing, decrease the need for healthcare professionals to perform diagnostic tests and reduce cross-contamination risk.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The inclusion and exclusion criteria for the various study populations are detailed above. General inclusion and exclusion criteria which apply to all study subjects are detailed followed by indication specific criteria are also detailed for both inclusion and exclusion.

Description

Inclusion Criteria:

  • Any adult >18 years with either a confirmed (phase 1) or suspected (phase 2&3) SARS-CoV-2 infection will be eligible to participate in this study.

Exclusion Criteria:

  • Subject who are deemed unlikely to be able to maintain oxygen saturation of greater than 90% while breathing room air for 30 seconds
  • Subject who require non-invasive ventilation or high flow nasal oxygen
  • Subject who require inotropic medication to maintain adequate organ perfusion
  • Subject who have a communication barrier and / or unable to comply with the instructions to use the Breath Biopsy test

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive control for technical validation
Time Frame: 1 year
The purpose of this stage is to confirm the optimal extraction protocol to detect the presence of SARS-CoV-2 from the aerosols captured in the Breath Biopsy RD device. Up to two Breath Biopsy RD sample will be collected alongside a nasopharyngeal. The swab obtained during this stage is to be analysed in parallel to the extracted breath aerosols in the lab of the lab and will be used as a positive control.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of test performance
Time Frame: 1 year
The aim is to assess the test performance of the Breath Biopsy RD devices in a real live clinical setting. Subjects with a high clinical suspicion of nCOVID-19 based on clinical triage will be requested to participate. A single Breath Biopsy RD collector will be collected in parallel with the standard diagnostic work-up consisting of a CT-scan and a nasopharyngeal swab.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of at home test
Time Frame: 1 year
The aim of the final outcome is to evaluate the performance and acceptability of using the Breath Biopsy RD as an at home test for identification of the presence of SARS-CoV-2. The OLVG phone application used for triage of the presence of nCOVID-19 will be used to identify subjects at the highest risk of having nCOVID-19. These subjects will be sent a Breath Biopsy RD collector and oropharyngeal swab for at home testing. Any subject who has a positive Breath Biopsy test for SARS-CoV-2 will be contacted and advised to receive a nasopharyngeal test for assessment of viral presence. Both tests will be self-administered to mimic an at home use scenario. The performance of both tests will be confirmed from the perspective of 1. Adherence 2. Subject comfort 3. Number of SARS-CoV-2 positive cases.
1 year

Collaborators and Investigators

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

Sponsor

Collaborators

Investigators

  • Study Chair: Paul Savelkoul,, OLVG
  • Study Chair: Paul Bresser, Maastricht

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)

September 30, 2020

Primary Completion (Actual)

December 19, 2020

Study Completion (Actual)

December 19, 2020

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 7, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • SARS-CoV-2 study

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

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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