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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Subjects will be recruited for the study during their scheduled appointments per clinical practice to the site, no separate study visit is required. The participant's involvement in the study will be limited to one visit (per routine practice) only. No additional follow up is required. For the purpose of the study a breath sample will be collected using the Breath Biopsy face masks. Collection of exhaled breath aerosols using these single use, disposable face masks will require subjects to breath normally into these face masks, the total collection time will not exceed one hour. It is expected to reduce collection times after initial validation steps to the shortest time providing sufficient diagnostic accuracy. Given the non-invasive nature of these breath collections subjects can immediately provide up to two samples using the Breath Biopsy face masks. The breath collection should occur within 24 hours of the diagnostic sample. Collected samples will be either frozen or shipped for rtPCR analysis of the presence of nCOVID-19 RNA. The two Breath Biopsy face masks can be used as technical replicates and/or to validate different storage conditions.

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

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Device: Breath Biopsy face masks with removable filters and fitted PVA strip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent Be 16 years or older Suspected or confirmed nCOVID-19 infection Exclusion Criteria: Subjects unable to provide written informed consent Ineligible subjects will specifically include subjects: deemed unlikely to be able to maintain oxygen saturation of greater than 90% while breathing room air for 30 seconds Require non-invasive ventilation or high flow nasal oxygen who require inotropic medication to maintain adequate organ perfusion communication barrier and / or unable to comply with the instructions to use the Breath Biopsy face masks

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Breath Biopsy face masks with removable filters and fitted PVA strip|Device developed for collection of breath samples|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of nCOVID-19 using a face mask | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Independent Patient use of face mask | 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 | 1 year |