FIND SARS-CoV-2
Research type
Research Study
Full title
A Feasibility study Using the CoronaCheck device to Identify iNciDent cases of SARS-CoV-2
IRAS ID
286654
Contact name
Thomas Brown
Contact email
Sponsor organisation
Portsmouth Hospitals University NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) is a new infectious disease, first noticed in Wuhan, China in December 2019 but has subsequently spread worldwide. It is more commonly known as COVID-19 (Coronavirus disease 2019) when symptoms are experienced.
SARS-CoV-2 is spread via small droplets in breath and aerosols and there is evidence supporting the accurate detection of the virus in exhaled breath condensate (EBC). The ACE2 protein (Angiotensin-Converting Enzyme 2) has been recognised as a key player in binding to SARS-CoV-2 allowing the virus to enter into cells. This study uses this protein to help detect the virus in exhaled breath condensate.
The Inflammacheck™ 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 Inflammacheck™ device during tidal breathing, making this investigation non-invasive, repeatable and easy to perform.
This study is phase 3 of a 3-part feasibility study. Phases 1 and 2 are already underway and are being successfully completed in laboratories in Imperial College London.
Technical proof of concept:
• Phase 1: To assess whether the ACE-2 sensor can detect Coronavirus.
• Phase 2: To assess whether the ACE-2 sensor can be used to detect COVID-19 in EBC.
Clinical proof of concept:
• Phase 3: To assess whether this Inflammacheck™ device can confirm or exclude COVID-19 in study participants. This is not intended as a validation study.REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0351
Date of REC Opinion
23 Sep 2020
REC opinion
Favourable Opinion