SARS (Severe Acute Respiratory Syndrome)NCT04649931
Differences in Exhaled Breath by Using Ion Mobility Spectrometry (IMS) in Subjects Tested for SARS-CoV-2 Infection (COVID-19 Disease)
An observational study of SARS (Severe Acute Respiratory Syndrome) and Covid19, run by B. Braun Melsungen AG at 1 site in Germany.
Trial summary
Breath gas analysis is the evaluation of exhaled breath. It aims to evaluate the volatile organic compounds (VOCs) in exhaled breath. In this feasibility study it is intended to find specific peaks/pattern in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS (Severe Acute Respiratory Syndrome), Covid19
- What is being tested?
- Ion Mobility Spectrometry (IMS)
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 1 siteGermany
- Study dates
- 14 Dec 2020to 25 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with suspected or diagnosed SARS-CoV-2 infection.
Who may be able to join
- PCR (= Polymerase Chain Reaction) testing for SARS CoV-2 will be/has been performed in a timely manner of sampling exhaled breath or PCR test for SARS-CoV-2 was performed within 96 hours, but preferably within 48 hours before sampling exhaled breath and PCR test result is already available
- Subject must be able to comply with study-specific procedures, e.g.is able to comply with breathing commands
Who cannot join
- Previous (history) SARS-CoV-2 infection, independent of the current episode
- Participation in a therapeutic study prior to breath analysis which could influence the result of the breath analysis
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Gießen and Marburg (UKGM), site Marburg
Marburg
About this study
Official title: Study to Evaluate Whether Differences in Exhaled Breath Can be Identified Using Ion Mobility Spectrometry (IMS) in Subjects Tested Positive for SARS-CoV-2 Infection and Subjects Tested Negative
Breath gas analysis is the evaluation of exhaled breath. It aims to evaluate the volatile organic compounds (VOCs) in exhaled breath.
In this feasibility study it is intended to find specific peaks/pattern in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
- Conditions
- SARS (Severe Acute Respiratory Syndrome), Covid19
- Being tested
- Ion Mobility Spectrometry (IMS)
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ion Mobility Spectrometry (IMS)Device
Two breathing gas samples will be taken from each study participant using ion mobility spectrometry with an ultrasound-based spirometer. The total sampling time is 1 minute (at least 5-7 breath takes) following an analysis time of 5-12 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 related volatile organic compounds (VOC)
Measured: 1 hour after breath gas sampling
Secondary outcomes (1)
To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 (Corona Virus Disease 2019)
Measured: within 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start14 Dec 2020
- Primary completion25 Apr 2021
- Study completion25 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS (Severe Acute Respiratory Syndrome)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CeGaT GmbH
- Responsible party
- Sponsor
- Investigators
- Juergen Schaefer, Prof. Dr., Principal investigator, University Hospital Marburg, Zentrum für unerkannte und seltene Erkrankungen (ZusE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649931
- Sponsor's protocol ID
- HC-N-H-2006
- Status last verified
- Apr 2021
- First submitted
- 25 Nov 2020
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Whether Differences in Exhaled Breath Can be Identified Using Ion Mobility Spectrometry (IMS) in Subjects Tested Positive for SARS-CoV-2 Infection and Subjects Tested Negative
- ClinicalTrials.gov ID
- NCT04649931
- Acronym / sponsor ID
- HC-N-H-2006
- Conditions
- SARS (Severe Acute Respiratory Syndrome), Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Collaborators
- CeGaT GmbH
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 25 Apr 2021 (actual)
- Study completion
- 25 Apr 2021 (actual)
- First posted
- 2 Dec 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.
Breath gas analysis is the evaluation of exhaled breath. It aims to evaluate the volatile organic compounds (VOCs) in exhaled breath.
In this feasibility study it is intended to find specific peaks/pattern in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with suspected or diagnosed SARS-CoV-2 infection.
Key inclusion criteria (2 listed)
- PCR (= Polymerase Chain Reaction) testing for SARS CoV-2 will be/has been performed in a timely manner of sampling exhaled breath or PCR test for SARS-CoV-2 was performed within 96 hours, but preferably within 48 hours before sampling exhaled breath and PCR test result is already available
- Subject must be able to comply with study-specific procedures, e.g.is able to comply with breathing commands
Key exclusion criteria (2 listed)
- Previous (history) SARS-CoV-2 infection, independent of the current episode
- Participation in a therapeutic study prior to breath analysis which could influence the result of the breath analysis
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 |
|---|---|---|
| Ion Mobility Spectrometry (IMS)Two breathing gas samples will be taken from each study participant using ion mobility spectrometry with an ultrasound-based spirometer. The total sampling time is 1 minute (at least 5-7 breath takes) following an analysis time of 5-12 minutes. | Device | – |
Primary outcome
SARS-CoV-2 related volatile organic compounds (VOC)
Time frame: 1 hour after breath gas sampling
1 secondary outcome
To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 (Corona Virus Disease 2019)
Time frame: within 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
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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.
Juergen Schaefer, Prof. Dr. principal investigator
University Hospital Marburg, Zentrum für unerkannte und seltene Erkrankungen (ZusE)
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 (Severe Acute Respiratory Syndrome) and Covid19, run by B. Braun Melsungen AG 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 3 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 related volatile organic compounds (VOC) (time frame: 1 hour after breath gas sampling). 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 3 May 2021.