No registrations found.
ID
Source
Brief title
Health condition
COVID
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objectives:
To determine the diagnostic accuracy of exhaled breath analysis by eNose at point of care
for discrimination between healthy controls and individuals with respiratory symptoms with
and without a Covid-19 infection.
Secondary outcome
Secondary Objectives:
To assess the accuracy of exhaled breath analysis by eNose at baseline for discrimination
between individuals with different disease progression (e.g. mild respiratory symptoms, ICU
admission and death).
Background summary
Rationale:
The World Health Organization (WHO) has recently characterized novel coronavirus (Covid-
19) as a pandemic due to its rapid spread and severity. Common clinical symptoms of the
disease include fever, cough, shortness of breath. However, in some patients the disease
progresses to more severe outcomes as such pneumonia, progressive respiratory failure and
even death. Currently, a Reverse Transcription-Polymerase Chain Reaction (rRT-PCR) test
is used to detect the virus using e.g. sputum samples. However, results of the test are often
available after three to four days. Therefore, there is an urgent need for a diagnostic tool with
a rapid turnaround time in processing Covid-19 test results and identify patients with higher
risk of fatal outcomes. Exhaled breath analysis using eNose technology linked to a cloud
solution may qualify for this.
Objective:
The overall aim of this pilot study is to determine the diagnostic accuracy of exhaled breath
analysis by eNose for the discrimination between patients with and without Covid-19 at point
of care.
Study design:
Prospective, observational, cross-sectional single-centre pilot study
Study population:
Individuals with a suspected diagnosis of Covid-19 infection.
Main study parameters/endpoints:
Exhaled breath profiles obtained by sampling exhaled air using real time eNose technology.
Nature and extent of the burden and risks associated with participation, benefit and
group relatedness:
As this concerns observational research using exhaled breath, no direct risk is involved with
participation in this study. Participation in this study does not affect the subjects' regular care.
Study objective
We hypothesize that exhaled breath analysis by eNose is able to discriminate between
patients with and without Covid-19 at point of care.
Study design
day 0 and 30
Intervention
None
Inclusion criteria
All newly presented individuals (>18 years of age) and health care personnel with a
suspected diagnosis of Covid-19 infection.
Exclusion criteria
- Recent (< 12 hours) intake of alcohol;
- Unwillingness or inability to comply with the study protocol for any other reason.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8694 |
| Other | METC LUMC : P20.033 |