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 NeonatologieProf. Dr. Michael ZemlinKirrbergerstraße, Gebäude 966421 HomburgGermany
- 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 NeonatologieDr. Sybelle Goedicke-FritzKirrbergerstraße, Gebäude 966421 HomburgGermany
- 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 NeonatologieDr. Sybelle Goedicke-FritzKirrbergerstraße, Gebäude 966421 HomburgGermany
- 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 NeonatologieDr. Sybelle Goedicke-FritzKirrbergerstraße, Gebäude 966421 HomburgGermany
- 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 12061348 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
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