Clinical trial NCT04508556: Performance Assessment of SARS-CoV-2 Detection Breath Biopsy - SARS-CoV-2 Study
Official title: Performance Assessment of SARS-CoV-2 Detection Through Analysis of Exhaled Breath Aerosols
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Owlstone Ltd
Sponsor class: INDUSTRY
Collaborators: name: OLVG
name: Maastricht University
First posted: 2020-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive control for technical validation
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of test performance
timeFrame: 1 year
Other outcomes:
measure: Evaluation of at home test
timeFrame: 1 year
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG
Study officials:
affiliation: OLVG
name: Paul Savelkoul,
role: STUDY_CHAIR
affiliation: Maastricht
name: Paul Bresser
role: STUDY_CHAIR
References: