Can the Electronic Nose Smell COVID-19 Antibodies?

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT04475575

Collaborator

(none)

222

Enrollment

Location

Arm

2.8

Actual Duration (Months)

78.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Corona Virus Disease (COVID-19), spread worldwide and has become an emergency of major international concern. In March 2020, the WHO declared the COVID-19 outbreak a global pandemic. Accurate and fast diagnosis is crucial in managing the pandemic. Current diagnostic approaches raise several difficulties: they are time-consuming, expensive, invasive, and most important lacking high sensitivity. The gold standard diagnostic test for COVID-19, reverse transcription polymerase chain reaction (RT-PCR), is highly dependent on adequate deep sampling of the swab in the naso- and oropharynx. A new diagnostic test that can correctly and rapidly identify infected patients and asymptomatic carriers is urgently required to prevent further virus transmission and thus reduce mortality rates.

Aim: This proof-of-principle study aims to investigate if an electronic nose (Aeonose) can distinguish individuals with antibodies from individuals without antibodies against COVID-19 based on analysis of volatile organic compounds (VOCs).

Methods: between April and July 2020, persons undergoing RT-PCR and a serology test for COVID-19 were recruited at Maastricht UMC+ for breath analysis. All participants had to breathe through the Aeonose for five consecutive minutes. The VOC pattern in their exhaled breath was then linked to the matching RT-PCR and serological test results.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV Infection Covid19	Device: Aeonose	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

222 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Can the Electronic Nose Smell COVID-19 Antibodies? A Proof-of-principle Study

Actual Study Start Date :

Apr 6, 2020

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: COVID-19 suspected Participants where included if an oropharyngeal and nasopharyngeal swab was collected for RT-PCR and serology testing had been performed, or if participants have had a confirmed COVID-19 diagnosis in the previous days or weeks with an indication for re-testing via PCR and serology testing at the moment of inclusion	Device: Aeonose All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. A nose clip was placed on the nose of each participant to avoid entry of non-filtered air in the device. Before measuring, the Aeonose was flushed with room air, guided through a carbon filter as well. During each measurement, a video was displayed to distract the participant and to reduce the chance of hyperventilation. Failed breath tests were excluded from analysis; the reason for failure was documented. Four similar Aeonose devices were used for breath analysis. A full-measurement procedure required sixteen minutes.

Arm

Intervention/Treatment

Other: COVID-19 suspected

Participants where included if an oropharyngeal and nasopharyngeal swab was collected for RT-PCR and serology testing had been performed, or if participants have had a confirmed COVID-19 diagnosis in the previous days or weeks with an indication for re-testing via PCR and serology testing at the moment of inclusion

Device: Aeonose

All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. A nose clip was placed on the nose of each participant to avoid entry of non-filtered air in the device. Before measuring, the Aeonose was flushed with room air, guided through a carbon filter as well. During each measurement, a video was displayed to distract the participant and to reduce the chance of hyperventilation. Failed breath tests were excluded from analysis; the reason for failure was documented. Four similar Aeonose devices were used for breath analysis. A full-measurement procedure required sixteen minutes.

Outcome Measures

Primary Outcome Measures

COVID-19 antibodies vs COVID-19 negative [3 months]
Ability of the electronic nose (Aeonose) to distinguish individuals with antibodies from individuals without antibodies against COVID-19 based on analysis of volatile organic compounds (VOCs).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants of whom an oropharyngeal and nasopharyngeal swab was collected for RT-PCR and on whom serology testing for the detection of antibodies was performed.