Can the Electronic Nose Smell COVID-19?

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04475562
Collaborator
(none)
219
1
1
2.8
77.5

Study Details

Study Description

Brief Summary

Infection with SARS-CoV-2 causes Corona Virus Disease (COVID-19). The most standard diagnostic method is reverse transcription-polymerase chain reaction (RT-PCR) on a nasopharyngeal and/or an oropharyngeal swab. The high occurrence of false-negative results due to the non-presence of SARS-CoV-2 in the oropharyngeal environment renders this sampling method not ideal. Therefore, a new sampling device is desirable. This proof-of-principle study investigates the possibility to train machine-learning classifiers with an electronic nose (Aeonose) to differentiate between COVID-19 positive- and negative persons based on volatile organic compounds (VOCs) analysis.

Methods: between April and June 2020, participants were invited for breath analysis when a swab for RT-PCR was collected. If the RT-PCR resulted negative, presence of SARS-CoV-2 specific antibodies was checked to confirm the negative result. 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. The result is a value between -1 and +1, indicating the infection probability.

Condition or Disease Intervention/Treatment Phase
  • Device: Aeonose
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
219 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? A Proof-of-principle Study
Actual Study Start Date :
Apr 6, 2020
Actual Primary Completion Date :
May 6, 2020
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: COVID-19 suspected

Participants were recruited at the outpatient clinic for MUMC+ employees with COVID-19 symptoms or at the nursing unit where a SARS-CoV-2 patient was admitted.

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

  1. COVID 19 positive vs negative [3 months]

    Ability of the eNose to distinguish COVID-19 positive from COVID-19 negative persons based on VOC patterns.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Participants of whom an oropharyngeal or nasopharyngeal swab was collected to perform RT-PCR on.
Exclusion Criteria:
  • Participants who were experiencing dyspnea or needed supplemental oxygen.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maastricht University Medical Center Maastricht Netherlands 6229 HX

Sponsors and Collaborators

  • Maastricht University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nicole Bouvy, Prof. Dr. Nicole D. Bouvy, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT04475562
Other Study ID Numbers:
  • eNoseCOVID
First Posted:
Jul 17, 2020
Last Update Posted:
Jul 17, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nicole Bouvy, Prof. Dr. Nicole D. Bouvy, Maastricht University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 17, 2020