Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04508556
Recruitment Status : Completed
First Posted : August 11, 2020
Last Update Posted : April 1, 2021
Sponsor:
Collaborators:
OLVG
Maastricht University
Information provided by (Responsible Party):
Owlstone Ltd

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Covid19 Device: Breath Biopsy face masks with removable filters and fitted PVA strip Diagnostic Test: Nasopharyngeal swab Diagnostic Test: oropharyngeal swabs

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Performance Assessment of SARS-CoV-2 Detection Through Analysis of Exhaled Breath Aerosols
Actual Study Start Date : September 30, 2020
Actual Primary Completion Date : December 19, 2020
Actual Study Completion Date : December 19, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: Breath Biopsy face masks with removable filters and fitted PVA strip
    Device developed for collection of breath samples
  • Diagnostic Test: Nasopharyngeal swab
    Is a method for collecting a clinical test sample of nasal secretions from the back of the nose and throat.
  • Diagnostic Test: oropharyngeal swabs
    Is a method for collecting a clinical test sample from the back of the throat.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508556


Locations
Layout table for location information
Netherlands
OLVG
Amsterdam, Netherlands, 1091
Sponsors and Collaborators
Owlstone Ltd
OLVG
Maastricht University
Investigators
Layout table for investigator information
Study Chair: Paul Savelkoul, OLVG
Study Chair: Paul Bresser Maastricht
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Owlstone Ltd
ClinicalTrials.gov Identifier: NCT04508556    
Other Study ID Numbers: SARS-CoV-2 study
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases