Establishing electronic nose and IMS as a screening tool for covid-19 - We smell Covid-19!

Organizational Data

DRKS-ID:
DRKS00027806
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2022-01-12
Last update in DRKS:
2022-05-06
Registration type:
Prospective

Acronym/abbreviation of the study

We smell Covid-19!

URL of the study

No Entry

Brief summary in lay language

Droplet infections represent one of the most important modes of transmission of infectious diseases and play a major role, particularly in indoor environments. As the COVID-19 pandemic continues spreading, early and real-time identification of SARS-CoV-2 infected individuals is important to break chains of infection. Rapid tests will help identify infected individuals before entering high-risk areas, thus helping to contain the spread of the pandemic. We have established the electronic nose and the ion mobility spectrometer coupled to multicapillary columns (MCC/IMS) as potential non-invasive diagnostic tools for the early detection of pathogens and their diseases in medicine. Both devices are able to detect so-called volatile organic compounds (VOC) which are generated during respiratory infections. The currently established methods create new possibilities in the fast, non-invasive diagnosis of respiratory tract infections based on VOCs in a variety of human samples. The risk-free application of the electronic nose and the MCC/IMS which is performed without any additional burden for the patient, increases its attractiveness for a multitude of medical questions.

Brief summary in scientific language

Epidemics and pandemics are in most cases caused by pathogens transmitted by droplet infection. Despite the possibility of vaccination, these diseases can lead to great damage. Novel mutations of SARS-CoV2 may alter transmission risk, disease progression, vaccine protection, and trigger new pandemic outbreaks. In particular, indoor settings where large numbers of people congregate, such as hospitals, schools, kindergartens, movie theaters, or public transit, provide an ideal environment for the transmission of droplet infections and aerosol spreading. Rapid tests are designed to detect infected individuals before they enter high-risk areas, thereby helping to contain the spread of the pandemic. However, conventional rapid antigen tests can be false-negative due to their limited sensitivity and specificity, are time-consuming and costly, and are particularly inconvenient for children and people with limited ability to cooperate (e.g., disabled people). Therefore, a rapid, non-contact diagnostic tool is urgently needed. Every infection triggers a characteristic inflammatory reaction and the production of typical soluble inflammatory mediators which are emitted as a particular smell consisting of numerous volatile organic compounds (VOCs). The Cyranose® 320 electronic nose is able to detect VOCs by means of several biopolymer sensors, and the ion mobility spectrometer coupled to multicapillary columns also enables VOC-analysis. Based on these detected substances, it is possible to determine so-called "smellprints", similar to a fingerprint within a few minutes. Based on our preliminary work, this study aims to establish Cyranose® 320 and the MCC/IMS as new time- and cost-efficient as well as non-invasive methods for the detection of droplet infections and aerosol transmission, especially SARS-CoV-2. We aim to transform and to complement traditional time-intensive screening with a real-time and low-contact diagnostic tool. Thus, we determine smellprints of biosamples of exhaled air, saliva, sputum and sweat of children and compare them to the results of SARS-CoV-2-PCR and rapid antigen tests. The goal is to establish the electronic nose and the MCC/IMS as a non-invasive screening method and the use as a simple and rapid entrance test for areas with high numbers of visitors and vulnerable areas.

Health condition or problem studied

Free text:
COVID-19
Free text:
Infection with SARS-CoV-2
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Patients of the Clinic for General Pediatrics and Neonatology (Wards and Emergency/ outpatient department): - Children from birth- Children from the age of 5. Patients of the Emergency Department of Internal Medicine/Pneumology: - Adults from the age of 18 The following materials are to be used as examination material: a) Exhaled air b) Saliva c) Sweat The following groups will be formed: - Children up to the age of 5 with diagnosed respiratory disease (n=250) - Adults with diagnosed respiratory disease (n=250)
Arm 2:
Patients of the Clinic for General Pediatrics and Neonatology (Wards and Emergency/ outpatient department): - Children from birth- Children from the age of 5. Patients of the Emergency Department of Internal Medicine/Pneumology: - Adults from the age of 18 The following materials are to be used as examination material: a) Exhaled air b) Saliva c) Sweat The following groups will be formed: - Children up to the age of 5 without diagnosed respiratory disease (n=250) - Adults without diagnosed respiratory disease (n=250)

Endpoints

Primary outcome:
Differences regarding the profile of infected persons and a control group.
Secondary outcome:
Real-time diagnostic of Covid-19-Infection

Study Design

Purpose:
Screening
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik für Allgemeine Pädiatrie und Neonatologie Homburg/ Saar

Recruitment period and number of participants

Planned study start date:
2022-02-01
Actual study start date:
2022-04-29
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
1000
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
5 Years
Maximum Age:
95 Years
Additional Inclusion Criteria:
- Adults and children up to the age of 5 without diagnosed acute respiratory disease - Adults and children up to the age of 5 with diagnosed acute respiratory disease

Exclusion Criteria

Age < 5 yrs

Addresses

Primary Sponsor

Address:
Universitätsklinikum des Saarlandes, Klinik für Allgemeine Pädiatrie und Neonatologie
Prof. Dr. Michael Zemlin
Kirrbergerstraße, Gebäude 9
66421 Homburg
Germany
Telephone:
06841/16 -28301
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.uks.eu/de/einrichtungen/kliniken_institute/kinder-und-jugendmedizin/klinik-fuer-allgemeine-paediatrie-und-neonatologie
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Universitätsklinikum des Saarlandes, Klinik für Allgemeine Pädiatrie und Neonatologie
Dr. Sybelle Goedicke-Fritz
Kirrbergerstraße, Gebäude 9
66421 Homburg
Germany
Telephone:
06841/16 -28301
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.uks.eu/de/einrichtungen/kliniken_institute/kinder-und-jugendmedizin/klinik-fuer-allgemeine-paediatrie-und-neonatologie

Contact for Public Queries

Address:
Universitätsklinikum des Saarlandes, Klinik für Allgemeine Pädiatrie und Neonatologie
Dr. Sybelle Goedicke-Fritz
Kirrbergerstraße, Gebäude 9
66421 Homburg
Germany
Telephone:
06841/16 -28301
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.uks.eu/de/einrichtungen/kliniken_institute/kinder-und-jugendmedizin/klinik-fuer-allgemeine-paediatrie-und-neonatologie

Principal Investigator

Address:
Universitätsklinikum des Saarlandes, Klinik für Allgemeine Pädiatrie und Neonatologie
Dr. Sybelle Goedicke-Fritz
Kirrbergerstraße, Gebäude 9
66421 Homburg
Germany
Telephone:
06841/16 -28301
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.uks.eu/de/einrichtungen/kliniken_institute/kinder-und-jugendmedizin/klinik-fuer-allgemeine-paediatrie-und-neonatologie

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

Address:
Else Kröner-Fresenius-Stiftung,Geschäftsstelle Bad Homburg v.d.H.
Louisenstraße 120
61348 Bad Homburg v.d.H.
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.ekfs.de/

Ethics Committee

Address Ethics Committee

Address:
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2022-03-07
Ethics committee number:
83/22
Vote of the Ethics Committee:
Approved
Date of the vote:
2022-04-14

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry