Status:
COMPLETED
Non Inferiority Trial for Detection of nCOVID-19 Through Analysis of Exhaled Breath Aerosols
Lead Sponsor:
Owlstone Ltd
Collaborating Sponsors:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
COVID
Eligibility:
All Genders
16+ years
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 d...
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...
Eligibility Criteria
Inclusion
- Provide written informed consent
- Be 16 years or older
- Suspected or confirmed nCOVID-19 infection
Exclusion
- 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
Key Trial Info
Start Date :
July 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 19 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04467112
Start Date
July 30 2020
End Date
December 19 2020
Last Update
March 30 2021
Active Locations (1)
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1
Cambridge University Hospital NHS
Cambridge, United Kingdom, CB2 0QQ