Status:
COMPLETED
Performance Assessment of SARS-CoV-2 Detection Breath Biopsy - SARS-CoV-2 Study
Lead Sponsor:
Owlstone Ltd
Collaborating Sponsors:
OLVG
Maastricht University
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Brief Summary
The primary aim of this study is to investigate the performance of Breath Biopsy RD for the detection of SARS-CoV-2 in both a clinical and at home setting.
Detailed Description
This study aims to evaluate Owlstone Medical's Breath Biopsy RD Collectors for the detection of SARS-CoV-2 infection. These single use disposable breath capture devices can be used independently by in...
Eligibility Criteria
Inclusion
- Any adult \>18 years with either a confirmed (phase 1) or suspected (phase 2\&3) SARS-CoV-2 infection will be eligible to participate in this study.
Exclusion
- Subject who are deemed unlikely to be able to maintain oxygen saturation of greater than 90% while breathing room air for 30 seconds
- Subject who require non-invasive ventilation or high flow nasal oxygen
- Subject who require inotropic medication to maintain adequate organ perfusion
- Subject who have a communication barrier and / or unable to comply with the instructions to use the Breath Biopsy test
Key Trial Info
Start Date :
September 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 19 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04508556
Start Date
September 30 2020
End Date
December 19 2020
Last Update
April 1 2021
Active Locations (1)
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1
OLVG
Amsterdam, Netherlands, 1091