Non-invasive Prognostication of COVID-19 Patients by Use of Biomarkers in Exhaled Breath Condensate
VTE-COVID-19
2 other identifiers
observational
28
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2020
CompletedFirst Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedFebruary 15, 2022
February 1, 2022
1 year
October 21, 2020
February 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 year
Secondary Outcomes (1)
Pathophysiology in COVID-19 patients
1 year
Eligibility Criteria
COVID-19 positive patients acutely admitted to Aalborg University Hospital due to COVID-19 symptoms.
You may qualify if:
- 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
You may not qualify if:
- Need for vasopressor therapy, mechanical ventilation, extracorporal circulation, or dialysis at admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inger Lise Gadelead
- Aarhus University Hospital Skejbycollaborator
Study Sites (1)
Aalborg Hospital
Aalborg, 9000, Denmark
Related Publications (1)
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.
PMID: 40341493DERIVED
Biospecimen
Exhaled breath condensate (EBC) Blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inger L Gade, MD, PhD
Aalborg University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD, Registrar
Study Record Dates
First Submitted
October 21, 2020
First Posted
October 22, 2020
Study Start
September 19, 2020
Primary Completion
October 1, 2021
Study Completion
October 1, 2021
Last Updated
February 15, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share