Performance Assessment of SARS-CoV-2 Detection Breath Biopsy - SARS-CoV-2 Study

NCT04508556 | Completed

• 1 other identifier: SARS-CoV-2 study
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Positive control for technical validation

  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 Outcomes (1)

• Evaluation of test performance

  1 year

Other Outcomes (1)

• Evaluation of at home test

  1 year

Interventions

Breath Biopsy face masks with removable filters and fitted PVA strip DEVICE

Device developed for collection of breath samples

Nasopharyngeal swab DIAGNOSTIC_TEST

Is a method for collecting a clinical test sample of nasal secretions from the back of the nose and throat.

oropharyngeal swabs DIAGNOSTIC_TEST

Is a method for collecting a clinical test sample from the back of the throat.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Owlstone Ltd: lead
• OLVG: collaborator
• Maastricht University: collaborator

Study Sites (1)

OLVG

Amsterdam, 1091, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The face mask will be placed onto the subject's face, covering his/her nose and mouth, head straps will be used to ensure that the face mask is kept in place for the duration of the test. This mask will contain a material designed to capture exhaled respiratory droplets and/or aerosols. Several iterations of these impaction and filtration devices may be used to optimize functional attributes of the material for capture of COVID. These materials will always have a proven safety for use with humans. Subjects can talk, cough and sneeze in the mask or can temporarily remove the mask if uncomfortable, to drink some water etc if required. Total collection time spread across two masks will not exceed one hour

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paul Savelkoul,

  OLVG

  STUDY CHAIR

• Paul Bresser

  Maastricht

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 11, 2020
• Study Start: September 30, 2020
• Primary Completion: December 19, 2020
• Study Completion: December 19, 2020
• Last Updated: April 1, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)