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OpenTrials
Completed

NCT Number: NCT04475562

Can the Electronic Nose Smell COVID-19?

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aeonose

Device

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2020
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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