SARS-CoV-2 InfectionNCT04547114
Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
An observational study of SARS-CoV-2 Infection, run by Klinikum Bayreuth GmbH at 1 site in Germany.
Trial summary
Recently published studies could demonstrate that detection of specific biomarkers in breath could be applied for the diagnosis of SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- Multicapillary column coupled ion mobility spectrometry
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 14 Sep 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult subjects of all genders and ages
Who may be able to join
- hospital admission staff members
Who cannot join
- too sick to comply with study procedures
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Bayreuth/ Bayreuth General Hospital
Bayreuth, 95445
Thomas Bollinger, MD, +49921400755810, thomas.bollinger@klinikum-bayreuth.de
Claus Steppert, MD, +499214004902, claus.steppert@klinikum-bayreuth.de
About this study
Recently published studies could demonstrate that detection of specific biomarkers in breath could be applied for the diagnosis of SARS-CoV-2.
Read the detailed description
In this study we want to address the sensitivity and specificity of breath analysis by MCC-IMS in the context of SARS-CoV-2 detection from PCR- proven infected and non-infected subjects.
Therefore nasal breath will be aspirated for 10 seconds during normal respiration by a foam cuffed oxygen catheter connected via a 0.22μm filter and a line into the MCC-IMS and directly analyzed without any pre-analytic procedures.
The during the proof-of-concept study derived significant peaks for volatile organic compounds will be used for discrimination in a point-of-care approach.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- Multicapillary column coupled ion mobility spectrometry
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicapillary column coupled ion mobility spectrometryDiagnostic test
sampling of nasal air via a foam cuffed oxygen catheter
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2- infected | Detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs Receives: Diagnostic Test: Multicapillary column coupled ion mobility spectrometry | |
| non infected | Lack of detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs Receives: Diagnostic Test: Multicapillary column coupled ion mobility spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
correct classification of SARS-CoV-2 infected and not infected subjects
correct classification of SARS-CoV-2 infected and not infected subjects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start14 Sep 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Bayreuth GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547114
- Sponsor's protocol ID
- IMS COVID-19
- Status last verified
- Sep 2020
- First submitted
- 11 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
- ClinicalTrials.gov ID
- NCT04547114
- Acronym / sponsor ID
- IMS COVID-19
- Conditions
- SARS-CoV-2 Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Klinikum Bayreuth GmbHIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently published studies could demonstrate that detection of specific biomarkers in breath could be applied for the diagnosis of SARS-CoV-2.
Detailed description
In this study we want to address the sensitivity and specificity of breath analysis by MCC-IMS in the context of SARS-CoV-2 detection from PCR- proven infected and non-infected subjects.
Therefore nasal breath will be aspirated for 10 seconds during normal respiration by a foam cuffed oxygen catheter connected via a 0.22μm filter and a line into the MCC-IMS and directly analyzed without any pre-analytic procedures.
The during the proof-of-concept study derived significant peaks for volatile organic compounds will be used for discrimination in a point-of-care approach.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2- infected | – | Diagnostic Test: Multicapillary column coupled ion mobility spectrometryDetection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs |
| non infected | – | Diagnostic Test: Multicapillary column coupled ion mobility spectrometryLack of detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects of all genders and ages
Key inclusion criteria (1 listed)
- hospital admission staff members
Key exclusion criteria (1 listed)
- too sick to comply with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicapillary column coupled ion mobility spectrometrysampling of nasal air via a foam cuffed oxygen catheter | Diagnostic test | SARS-CoV-2- infected, non infected |
Primary outcome
correct classification of SARS-CoV-2 infected and not infected subjects
Time frame: 6 months
correct classification of SARS-CoV-2 infected and not infected subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klinikum Bayreuth/ Bayreuth General Hospital
Bayreuth, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Infection, run by Klinikum Bayreuth GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correct classification of SARS-CoV-2 infected and not infected subjects (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.