A Feasibility Study Using the CoronaCheck Device to Identify Incident Cases of SARS CoV-2 Covid-19

Study Overview
=================
Brief Summary
-----------------
Point of care testing is urgently required to enable the immediate detection of SARS-CoV-2 infection to allow effective transmission prevention precautions to succeed.

Detailed Description
-----------------
The Coronacheck device is a hand-held, portable, point-of-care device which will allow the safe collection of EBC. It provides an automated platform for the detection of SARS-CoV-2 using an existing sensor repurposed with immobilised recombinant ACE-2 to bind the virus. This produces a measurable signal indicating whether SARS-CoV-2 is present or not. EBC is collected by the CoronaCheck device during tidal breathing, making this investigation non-invasive, repeatable and easy to perform. Previous studies using Inflammacheck™ in people with respiratory conditions have shown it is well tolerated, even in people with severe lung disease. The full test cycle including sample collection and test assay typically occurs in less than 5 minutes. Given the risk of infection, this CoronaCheck™ device has an integrated sensor and breath collection system combined in a fully enclosed, disposable unit to mitigate the risk of cross-infections between users and also reduces any exposure risk to healthcare staff. It is appreciated that disposable plastic has a negative environmental impact, however due to the highly contagious nature of SARS-CoV-2 it is felt unavoidable at present. Using the CoronaCheck does not require laboratory equipment or expertise, and is a quick, easy-to-use point-of-care investigation which provides an immediate result. This could potentially be applied to screening for SARS-CoV-2 in a wide variety of environments for example: GP practices, drive-thru centres, colleges, universities, airports and sports arenas. Any person undergoing a swab for a possible SARS CoV-2 infection is eligible for inclusion, participants will not be assigned an intervention. The participants will breathe into the CoronaCheck device. This involves breathing for up to 6 minutes into a single use, fully sealed unit attached to the hand-held device. This disposable unit has a bacterial-viral filter attached to both the breathing inlet and the exhale outlet to eliminate any risk of contamination. The CoronaCheck device then provides a reading reflecting EBC ACE2 binding which will be documented on the eCRF. This result will not be recorded in the clinical notes as it is not intended to inform patient management decisions in this study.

Official Title
-----------------
A Feasibility Study Using the CoronaCheck Device to Identify Incident Cases of SARS CoV-2 - FIND SARS CoV-2 Covid-19

Conditions
-----------------
SARS-CoV Infection

Intervention / Treatment
-----------------
* Device: CoronaCheck Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: o Any adult (≥ 16 years of age) who is: undergoing a swab for possible SARS-CoV-2 infection willing and able to give informed consent for participation in the study unlikely to suffer harm as a result of testing in the opinion of the investigator Exclusion Criteria: o Participants receiving: invasive ventilation, non-invasive ventilation or nasal high flow oxygen supplementary oxygen with symptomatic hypoxia or oxygen saturations ≤92% (≤88% in COPD) despite 4L oxygen via nasal cannulae unable to comprehend the study or provide informed consent

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CoronaCheck Device|All participants breath normally into the device for up to 6 minutes|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of SARS-CoV-2 infection in those with high clinical suspicion and/or a positive RT-PCR swab. | Measured using the CoronaCheck device | through study completion, an average of 1 year |