Covid19NCT04556318
Identification of Differences in Breath Components Detected With IMS in Patients Tested on SARS-CoV-2 (COVID-19)
An observational study of Covid19, run by B. Braun Melsungen AG at 2 sites in Germany.
Trial summary
Breath analysis is the evaluation of exhaled air of humans. It aims to get information about the clinical status of a human being by monitoring its volatile organic compounds (VOCs) in exhaled air. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Ion Mobility Spectrometry (IMS)
- Type of treatment
- Medical device
- How many people
- 396 participants
- Where
- 2 sitesGermany
- Study dates
- 23 Sep 2020to 11 Jun 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: Patients with signs or symptoms of any respiratory system infection or signs or symptoms indicating SARS-CoV-2 infection or radiological findings suggesting viral lung infection
Who may be able to join
- SARS-CoV-2-Polymerase chain reaction (PCR) test result is available
- Signs or symptoms of any respiratory system infection or Signs or symptoms indicating SARS-CoV-2 infection or Radiological findings suggesting viral lung infection
- Breath test (Study intervention) must be performed within a 2 day time period after latest SARS-CoV-2 PCR
Who cannot join
- History of SARS-CoV-2 outside the current respiratory episode (known from medical history)
- Participation in another clinical study prior to breath analysis which could influence the result of the breath analysis
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin
Technical University of Munich, Klinikum rechts der Isar
Munich
About this study
Official title: Study to Identify Differences of Exhaled Breath Components Using Ion Mobility Spectrometry (IMS) in Patients Tested Positive or Negative on SARS-CoV-2
Breath analysis is the evaluation of exhaled air of humans. It aims to get information about the clinical status of a human being by monitoring its volatile organic compounds (VOCs) in exhaled air.
In this feasibility study it is intended to find specific biomarker(s) in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
- Conditions
- Covid19
- Being tested
- Ion Mobility Spectrometry (IMS)
- Medical subject headings
- 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 and diagnostic findings
Measured: Within 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start23 Sep 2020
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Spinner, PD Dr., Principal investigator, Technical University of Munich, Klinikum rechts der Isar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556318
- Sponsor's protocol ID
- HC-N-H-2004
- Status last verified
- Jul 2021
- First submitted
- 18 Sep 2020
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Voit F, Erber J, Feuerherd M, Fries H, Bitterlich N, Diehl-Wiesenecker E, Gladis S, Lieb J, Protzer U, Schneider J, Geisler F, Somasundaram R, Schmid RM, Bauer W, Spinner CD. Rapid point-of-care detection of SARS-CoV-2 infection in exhaled breath using ion mobility spectrometry: a pilot study. Eur J Med Res. 2023 Sep 2;28(1):318. doi: 10.1186/s40001-023-01284-3.
PubMed 37660038
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Identify Differences of Exhaled Breath Components Using Ion Mobility Spectrometry (IMS) in Patients Tested Positive or Negative on SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04556318
- Acronym / sponsor ID
- HC-N-H-2004
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 21 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.
Breath analysis is the evaluation of exhaled air of humans. It aims to get information about the clinical status of a human being by monitoring its volatile organic compounds (VOCs) in exhaled air.
In this feasibility study it is intended to find specific biomarker(s) 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
- Patients with signs or symptoms of any respiratory system infection or signs or symptoms indicating SARS-CoV-2 infection or radiological findings suggesting viral lung infection
Key inclusion criteria (3 listed)
- SARS-CoV-2-Polymerase chain reaction (PCR) test result is available
- Signs or symptoms of any respiratory system infection or Signs or symptoms indicating SARS-CoV-2 infection or Radiological findings suggesting viral lung infection
- Breath test (Study intervention) must be performed within a 2 day time period after latest SARS-CoV-2 PCR
Key exclusion criteria (2 listed)
- History of SARS-CoV-2 outside the current respiratory episode (known from medical history)
- Participation in another clinical 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 and diagnostic findings
Time frame: Within 3 days
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 8 Jul 2021.
- Derived from this study: PubMed 37660038Voit F, Erber J, Feuerherd M, Fries H, Bitterlich N, Diehl-Wiesenecker E, Gladis S, Lieb J, Protzer U, Schneider J, Geisler F, Somasundaram R, Schmid RM, Bauer W, Spinner CD. Rapid point-of-care detection of SARS-CoV-2 infection in exhaled breath using ion mobility spectrometry: a pilot study. Eur J Med Res. 2023 Sep 2;28(1):318. doi: 10.1186/s40001-023-01284-3.
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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.
Christoph Spinner, PD Dr. principal investigator
Technical University of Munich, Klinikum rechts der Isar
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by B. Braun Melsungen AG at 2 sites 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 3 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 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
On the ClinicalTrials.gov record for NCT04556318, which also lists 1 linked publication.
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 8 Jul 2021.