Covid19VTE-COVID-19NCT04598620
Non-invasive Prognostication of COVID-19 Patients by Use of Biomarkers in Exhaled Breath Condensate
An observational study of Covid19 and Corona Virus Infection, run by Inger Lise Gade at 1 site in Denmark.
Trial summary
The main objective of this study is to assess if analysis of exhaled breath condensate (EBC) can provide useful prognostic markers for admission to the intensive care unit (ICU) due to acute respiratory insufficiency among patients with Coronavirus disease 2019 (COVID-19). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Corona Virus Infection
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Sep 2020to 1 Oct 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: COVID-19 positive patients acutely admitted to Aalborg University Hospital due to COVID-19 symptoms.
Who may be able to join
- Age ≥18 years and admitted at Aalborg Hospital with confirmed COVID-19
- Need for hospitalization due to COVID-19 symptoms.
- Able to provide informed consent
Who cannot join
- Need for vasopressor therapy, mechanical ventilation, extracorporal circulation, or dialysis at admission
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to assess if analysis of exhaled breath condensate (EBC) can provide useful prognostic markers for admission to the intensive care unit (ICU) due to acute respiratory insufficiency among patients with Coronavirus disease 2019 (COVID-19). Additionally, to give a characterization of the lung damage caused by COVID-19 by analysis of daily blood samples.
The hypothesis is that the protein content of the EBC from COVID-19 patients who require admission to the ICU differs from the EBC from COVID-19 patients with uncomplicated hospitalization, potentially providing diagnostic markers of COVID-19 related pulmonary damage.
Read the detailed description
Two EBC samples will be collected from each study participant; a baseline sample (at admission) and a sample at either hospital discharge or transfer to the ICU. In addition, blood samples will be collected in order to investigate the pathophysiology of COVID-19 using metabolomics analysis, and for standardization and validation of the putative markers from the EBC.
The investigators will collect EBC from COVID-19 positive patients acutely admitted to Aalborg University Hospital due to COVID-19 symptoms and compare the protein and metabolite profiles in patients, who are treated at the ward with patients, who are transferred to the ICU for mechanical ventilation. The main-outcome (i.e. means of the relative amounts of specific proteins in the EBC samples) will be compared by unpaired t-tests after assessment of normality and standard deviations within the two groups in the following comparison: EBC collected at admission (baseline) from patients who did not need mechanical ventilation vs. EBC at admission from patients who did need mechanical ventilation. Paired t-tests will compare the proteins in baseline EBC samples and samples at either transfer to the ICU intubation or discharge to home in order to describe the pathophysiology in the two groups (no ICU need versus need of ICU admission). The investigators will not collect EBC from patients admitted to the ICU for open-circuit respiratory support, e.g. high-flow oxygenation; these patients will be asked to give an EBC sample before discharge, like the patients who did not need ICU care.
A blood sample will be drawn at the two days of EBC collection (i.e. a 9 mL tube drawn along with routine work-up blood samples) from the study participants for two purposes: 1) Standardization of the putative markers and verification and supplementing analysis of the EBC markers. In order to qualify the most suitable markers and substrates for standardization, the analysis of the EBC samples must be completed before the blood samples can be analyzed. Conventional biochemical analysis will be used for this purpose. 2) Pathophysiological description of patients hospitalized with COVID-19 using metabolomics and proteomics analysis. No genetic analysis will be conducted on the stored blood samples.
After collection of the EBC, the samples will be stored directly in the collection tube marked with study subject id at -80⁰C. The EBC samples will be used solely for the subsequent analysis of the protein composition (i.e. proteomics) and metabolites (i.e. metabolomics).
The collection of EBC will not lead to deviations from standard diagnostic procedures or treatments. The patients will have routine blood samples drawn as a part of the diagnostic work-up and daily disease monitoring. The investigators will ask for consent to draw an extra 9 mL blood sample along with the routine blood samples at the two days of EBC collection.
- Conditions
- Covid19, Corona Virus Infection
- Keywords
- Exhaled breath condensate
- Medical subject headings
- COVID-19, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of admission to ICU in hospitalized COVID-19 patients
The primary outcome is prediction of admission to ICU in hospitalized COVID-19 patients by use of one or more novel biomarkers in the EBC
Measured: 1 year
Secondary outcomes (1)
Pathophysiology in COVID-19 patients
In a sub-study, we will collect the daily blood samples for analysis in order to investigate the pathophysiology in COVID-19, and for standardization and validation of putative EBC markers in the blood.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start19 Sep 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inger Lise Gade
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital Skejby
- Responsible party
- Sponsor-investigator, Inger Lise Gade, Aalborg University Hospital
- Investigators
- Inger L Gade, MD, PhD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598620
- Sponsor's protocol ID
- ILG-VTE-COVID-19-2020
- Other IDs
- N-20200069
- Acronym
- VTE-COVID-19
- Status last verified
- Feb 2022
- First submitted
- 21 Oct 2020
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gade IL, Bodilsen J, Mariager T, Hertz S, Duerlund LS, Holm CK, Madsen PH, Bennike TB, Honore B. Exhaled breath protein composition in patients hospitalised during the first wave of COVID-19. J Breath Res. 2025 May 16;19(3). doi: 10.1088/1752-7163/add617.
PubMed 40341493
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Prognostication of COVID-19 Patients by Use of Biomarkers in Exhaled Breath Condensate
- ClinicalTrials.gov ID
- NCT04598620
- Acronym / sponsor ID
- VTE-COVID-19 / ILG-VTE-COVID-19-2020
- Conditions
- Covid19, Corona Virus Infection
- Keywords
- Exhaled breath condensate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Inger Lise GadeUniversity, hospital or other
- Collaborators
- Aarhus University Hospital Skejby
- Study start
- 19 Sep 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 22 Oct 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.
The main objective of this study is to assess if analysis of exhaled breath condensate (EBC) can provide useful prognostic markers for admission to the intensive care unit (ICU) due to acute respiratory insufficiency among patients with Coronavirus disease 2019 (COVID-19). Additionally, to give a characterization of the lung damage caused by COVID-19 by analysis of daily blood samples.
The hypothesis is that the protein content of the EBC from COVID-19 patients who require admission to the ICU differs from the EBC from COVID-19 patients with uncomplicated hospitalization, potentially providing diagnostic markers of COVID-19 related pulmonary damage.
Detailed description
Two EBC samples will be collected from each study participant; a baseline sample (at admission) and a sample at either hospital discharge or transfer to the ICU. In addition, blood samples will be collected in order to investigate the pathophysiology of COVID-19 using metabolomics analysis, and for standardization and validation of the putative markers from the EBC.
The investigators will collect EBC from COVID-19 positive patients acutely admitted to Aalborg University Hospital due to COVID-19 symptoms and compare the protein and metabolite profiles in patients, who are treated at the ward with patients, who are transferred to the ICU for mechanical ventilation. The main-outcome (i.e. means of the relative amounts of specific proteins in the EBC samples) will be compared by unpaired t-tests after assessment of normality and standard deviations within the two groups in the following comparison: EBC collected at admission (baseline) from patients who did not need mechanical ventilation vs. EBC at admission from patients who did need mechanical ventilation. Paired t-tests will compare the proteins in baseline EBC samples and samples at either transfer to the ICU intubation or discharge to home in order to describe the pathophysiology in the two groups (no ICU need versus need of ICU admission). The investigators will not collect EBC from patients admitted to the ICU for open-circuit respiratory support, e.g. high-flow oxygenation; these patients will be asked to give an EBC sample before discharge, like the patients who did not need ICU care.
A blood sample will be drawn at the two days of EBC collection (i.e. a 9 mL tube drawn along with routine work-up blood samples) from the study participants for two purposes: 1) Standardization of the putative markers and verification and supplementing analysis of the EBC markers. In order to qualify the most suitable markers and substrates for standardization, the analysis of the EBC samples must be completed before the blood samples can be analyzed. Conventional biochemical analysis will be used for this purpose. 2) Pathophysiological description of patients hospitalized with COVID-19 using metabolomics and proteomics analysis. No genetic analysis will be conducted on the stored blood samples.
After collection of the EBC, the samples will be stored directly in the collection tube marked with study subject id at -80⁰C. The EBC samples will be used solely for the subsequent analysis of the protein composition (i.e. proteomics) and metabolites (i.e. metabolomics).
The collection of EBC will not lead to deviations from standard diagnostic procedures or treatments. The patients will have routine blood samples drawn as a part of the diagnostic work-up and daily disease monitoring. The investigators will ask for consent to draw an extra 9 mL blood sample along with the routine blood samples at the two days of EBC collection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 positive patients acutely admitted to Aalborg University Hospital due to COVID-19 symptoms.
Key inclusion criteria (3 listed)
- Age ≥18 years and admitted at Aalborg Hospital with confirmed COVID-19
- Need for hospitalization due to COVID-19 symptoms.
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Need for vasopressor therapy, mechanical ventilation, extracorporal circulation, or dialysis at admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction of admission to ICU in hospitalized COVID-19 patients
Time frame: 1 year
The primary outcome is prediction of admission to ICU in hospitalized COVID-19 patients by use of one or more novel biomarkers in the EBC
1 secondary outcome
Pathophysiology in COVID-19 patients
Time frame: 1 year
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 15 Feb 2022.
- Derived from this study: PubMed 40341493Gade IL, Bodilsen J, Mariager T, Hertz S, Duerlund LS, Holm CK, Madsen PH, Bennike TB, Honore B. Exhaled breath protein composition in patients hospitalised during the first wave of COVID-19. J Breath Res. 2025 May 16;19(3). doi: 10.1088/1752-7163/add617.
- 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.
Inger L Gade, MD, PhD principal investigator
Aalborg University Hospital
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 Covid19 and Corona Virus Infection, run by Inger Lise Gade at 1 site in Denmark.
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 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: finished, as of the sponsor's last update on 15 Feb 2022. 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 Denmark. 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?
Prediction of admission to ICU in hospitalized COVID-19 patients (time frame: 1 year). 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 NCT04598620, 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 15 Feb 2022.