CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Breath Biopsy face masks with removable filters and fitted PVA stripWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug2964 Trauma-informed yoga video recording Wiki 0.71
drug3395 oropharyngeal swabs Wiki 0.71
drug1977 Online Survey Wiki 0.35
drug1841 Nasopharyngeal swab Wiki 0.35

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D001008 Anxiety Disorders NIH 0.22

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There are 2 clinical trials

Clinical Trials

1 Non Inferiority Trial for Detection of nCOVID-19 Through Analysis of Exhaled Breath Aerosols

This study aims to evaluate several of Owlstone Medical's Breath Biopsy aerosol respiratory droplet capture techniques for the detection of nCOVID-19. These are single use disposable breath capture devices with removable filters and fitted PVA strip that directly sample exhaled breath aerosols and therefore, directly sample the primary transmission route for the virus. They can be used independently and shipped for analysis for the presence of nCOVID-19 using established existing assays available in any reference lab. The trial is a non-inferiority trial comparing diagnostic accuracy of collection via face mask vs. available diagnostic procedures in standard care and will also asses the feasibility of patient use of the equipment. Subjects will be recruited at the Addenbrookes Hospital, Cambridge. Minimal patient characteristics (e.g. age, sex) are collected. Between 20 and 100 subjects with with a positive nCOVID-19 diagnosis will be sampled to obtain to address the primary study hypothesis. Due to the pre-test probability of patients being positive for nCOVID-19 is unknown we will monitor the number of sampled subjects with a positive diagnosis on a weekly basis. The clinical diagnosis of the subject based on a combination of imaging, viral diagnostics and clinical assessment will be used as the reference standard. When this number hits 100 the study will be discontinued. In total no more than 500 subjects shall be sampled in this trial.

NCT04467112 COVID Device: Breath Biopsy face masks with removable filters and fitted PVA strip

Primary Outcomes

Description: The primary aim of this study is to establish non-inferiority of the Breath Biopsy face masks with various respiratory droplet (aerosol) capture techniques for the detection of nCOVID-19 compared to the current diagnostic test results per standard practice.

Measure: Detection of nCOVID-19 using a face mask

Time: 1 year

Secondary Outcomes

Description: The secondary objective is to assess the feasibility of independent use of the Breath Biopsy face masks. This will be measured by means of patient reported feedback on their level of comfort in performing the breath collection

Measure: Independent Patient use of face mask

Time: 1 year

2 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.

NCT04508556 Covid19 Device: Breath Biopsy face masks with removable filters and fitted PVA strip Diagnostic Test: Nasopharyngeal swab Diagnostic Test: oropharyngeal swabs

Primary Outcomes

Description: 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.

Measure: Positive control for technical validation

Time: 1 year

Secondary Outcomes

Description: 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.

Measure: Evaluation of test performance

Time: 1 year

Other Outcomes

Description: 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.

Measure: Evaluation of at home test

Time: 1 year

No related HPO nodes (Using clinical trials)