- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05137249
The Glycocalyx in COVID-19 Patients. A Pilot Study (Glycovid-19)
November 24, 2021 updated by: Judith Schiefer, Medical University of Vienna
The damage of the endothelial glycocalyx is based on microvascular endothelial dysfunction and typical for critical clinical conditions like sepsis, trauma, bleeding, shock, as well as ARDS.
We aim to generate first hints regarding the impact of covid-19 disease on the (damage) of the endothelial glycocalyx.
Furthermore, we want to investigate the potential coagulopathies, which go along with shedding of the glycocalyx.
The detection of and the relation between the severity of the disease, as well as the extent of the glycocalyx damage during the observational period, as well as the hemostatic alterations, are aim of the study.
Study Overview
Status
Completed
Conditions
Detailed Description
The damage of the endothelial glycocalyx is based on microvascular endothelial dysfunction and typical for critical clinical conditions like sepsis, trauma, bleeding, shock, as well as ARDS.
We aim to generate first hints regarding the impact of covid-19 disease on the (damage) of the endothelial glycocalyx.
Furthermore, we want to investigate the potential coagulopathies, which go along with shedding of the glycocalyx.
The detection of and the relation between the severity of the disease, as well as the extent of the glycocalyx damage during the observational period, as well as the hemostatic alterations, are aim of the study.Circulating plasma syndecan-1 is measured as surrogat parameter for the extent of the glycocalyx damage.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria
- Medical University of Vienna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients diagnosed and hospitalized with COVID 19 due to clinical symptoms.
Description
Inclusion Criteria:
- COVID-19 detected by PCR measures going along with clinical symptoms
- age > 18 years
Exclusion Criteria:
- refusal of study participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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patients with COVID 19 disease
Patients diagnosed with and hospitalized due to COVID-19.
Subgroups: ICU admitted COVID-19 + patients vs COVID 19 pts. at normal ward-
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Healthy volunteers
healthy volnuteers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
extent of endothelial damage
Time Frame: up to 2 months
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circulating plasma syndecan-1 as surrogat parameter for endothelial damage is measures
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up to 2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Judith Schiefer, MD PhD, Medical University of Vienna, Department of Anesthesia, Intensive Care Medicine and Pain Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
March 1, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
November 24, 2021
First Submitted That Met QC Criteria
November 24, 2021
First Posted (Actual)
November 30, 2021
Study Record Updates
Last Update Posted (Actual)
November 30, 2021
Last Update Submitted That Met QC Criteria
November 24, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- COVID-19
- Hemostatic Disorders
- Blood Coagulation Disorders
Other Study ID Numbers
- EK Nr: 1590/2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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