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

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

      • Vienna, Austria
        • Medical University of Vienna

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
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-
Healthy volunteers
healthy volnuteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
extent of endothelial damage
Time Frame: up to 2 months
circulating plasma syndecan-1 as surrogat parameter for endothelial damage is measures
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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