Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04598620
Status:
COMPLETED
Last Update Posted:
2022-02-15
First Post:
2020-10-21
Brief Title:
Non-invasive Prognostication of COVID-19 Patients by Use of Biomarkers in Exhaled Breath Condensate
Sponsor:
Inger Lise Gade
Organization:
Aalborg University Hospital
Study Overview
Official Title:
Non-invasive Prognostication of COVID-19 Patients by Use of Biomarkers in Exhaled Breath Condensate
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VTE-COVID-19
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
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 ie 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 eg 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 ie 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 ie proteomics and metabolites ie 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
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 ie 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 eg 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 ie 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 ie proteomics and metabolites ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N-20200069 | OTHER | Den Videnskabsetiske Komite for Region Nordjylland | None |