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Can the Electronic Nose Smell COVID-19 Antibodies?

Primary Purpose

SARS-CoV Infection, Covid19

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Aeonose
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for SARS-CoV Infection focused on measuring Electronic nose, Volatile organic compounds, Diagnosis, Serology, Antibodies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Exclusion Criteria:

  • Participants who where experiencing dyspnea or needed supplemental oxygen.

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

COVID-19 suspected

Arm Description

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

Outcomes

Primary Outcome Measures

COVID-19 antibodies vs COVID-19 negative
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).

Secondary Outcome Measures

Full Information

First Posted
July 15, 2020
Last Updated
July 16, 2020
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04475575
Brief Title
Can the Electronic Nose Smell COVID-19 Antibodies?
Official Title
Can the Electronic Nose Smell COVID-19 Antibodies? A Proof-of-principle Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 6, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection, Covid19
Keywords
Electronic nose, Volatile organic compounds, Diagnosis, Serology, Antibodies

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 suspected
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Aeonose
Intervention Description
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 Outcome Measure Information:
Title
COVID-19 antibodies vs COVID-19 negative
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Exclusion Criteria: Participants who where experiencing dyspnea or needed supplemental oxygen.
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
32091533
Citation
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
Results Reference
background
PubMed Identifier
24421258
Citation
de Lacy Costello B, Amann A, Al-Kateb H, Flynn C, Filipiak W, Khalid T, Osborne D, Ratcliffe NM. A review of the volatiles from the healthy human body. J Breath Res. 2014 Mar;8(1):014001. doi: 10.1088/1752-7155/8/1/014001. Epub 2014 Jan 13.
Results Reference
background
PubMed Identifier
32306047
Citation
Xiang F, Wang X, He X, Peng Z, Yang B, Zhang J, Zhou Q, Ye H, Ma Y, Li H, Wei X, Cai P, Ma WL. Antibody Detection and Dynamic Characteristics in Patients With Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 5;71(8):1930-1934. doi: 10.1093/cid/ciaa461.
Results Reference
background
PubMed Identifier
29909757
Citation
Schuermans VNE, Li Z, Jongen ACHM, Wu Z, Shi J, Ji J, Bouvy ND. Pilot Study: Detection of Gastric Cancer From Exhaled Air Analyzed With an Electronic Nose in Chinese Patients. Surg Innov. 2018 Oct;25(5):429-434. doi: 10.1177/1553350618781267. Epub 2018 Jun 18.
Results Reference
background
PubMed Identifier
26056127
Citation
Bikov A, Lazar Z, Horvath I. Established methodological issues in electronic nose research: how far are we from using these instruments in clinical settings of breath analysis? J Breath Res. 2015 Jun 9;9(3):034001. doi: 10.1088/1752-7155/9/3/034001.
Results Reference
background
PubMed Identifier
23956311
Citation
Bijland LR, Bomers MK, Smulders YM. Smelling the diagnosis: a review on the use of scent in diagnosing disease. Neth J Med. 2013 Jul-Aug;71(6):300-7.
Results Reference
background
PubMed Identifier
27310311
Citation
van Geffen WH, Bruins M, Kerstjens HA. Diagnosing viral and bacterial respiratory infections in acute COPD exacerbations by an electronic nose: a pilot study. J Breath Res. 2016 Jun 16;10(3):036001. doi: 10.1088/1752-7155/10/3/036001.
Results Reference
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Can the Electronic Nose Smell COVID-19 Antibodies?

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