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Can the Electronic Nose Smell COVID-19?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04475562
Recruitment Status : Completed
First Posted : July 17, 2020
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Nicole Bouvy, Maastricht University Medical Center

Study Description
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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
SARS-CoV Infection Covid19 Device: Aeonose Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : April 6, 2020
Actual Primary Completion Date : May 6, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. COVID 19 positive vs negative [ Time Frame: 3 months ]
    Ability of the eNose to distinguish COVID-19 positive from COVID-19 negative persons based on VOC patterns.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475562


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
More Information
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Publications:

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Responsible Party: Nicole Bouvy, Prof. Dr. Nicole D. Bouvy, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT04475562    
Other Study ID Numbers: eNoseCOVID
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nicole Bouvy, Maastricht University Medical Center:
Electronic nose
Volatile organic compounds
Diagnosis
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases