COVID-BREATH [COVID-19]
Research type
Research Study
Full title
Non inferiority trial for detection of nCOVID-19 through analysis of exhaled breath aerosols\n
IRAS ID
237557
Contact name
Stefan Marciniak
Contact email
Sponsor organisation
Owlstone Medical Ltd
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
This study aims to evaluate several of Owlstone Medical’s Breath Biopsy aerosol respiratory droplet capture techniques for the detection of nCOVID-19. \n \nThese 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.\n\nThe 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. \n\nAny individual older than 16 with suspected or confirmed nCOVID-19 infection will be eligible to participate.\nIneligible subjects will specifically include subjects:\n•\tdeemed unlikely to be able to maintain oxygen saturations of greater than 90% while breathing room air for 30 seconds Require non-invasive ventilation or high flow nasal oxygen\n•\twho require inotropic medication to maintain adequate organ perfusion\n•\tcommunication barrier and / or unable to comply with the instructions to use the devices\nEligibility is furthermore at the discretion of the investigator. \n\nSubjects will be recruited at the Addenbrookes Hospital, Cambridge. Minimal patient characteristics (e.g. age, sex) are collected. \n\nBetween 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.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
20/LO/0581
Date of REC Opinion
30 Mar 2020
REC opinion
Further Information Favourable Opinion