Glycovid-19: The Glycocalyx in COVID-19 Patients. A Pilot Study

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT05137249
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 5
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Endothelial Dysfunction; Coagulation Disorder

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 Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Glycocalyx in COVID-19 Patients. A Pilot Study
• Actual Study Start Date: Dec 1, 2020
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. extent of endothelial damage [up to 2 months]

   circulating plasma syndecan-1 as surrogat parameter for endothelial damage is measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• COVID-19 detected by PCR measures going along with clinical symptoms

• age > 18 years

Exclusion Criteria:

• refusal of study participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria

Sponsors and Collaborators

• Medical University of Vienna

Investigators

• Principal Investigator: Judith Schiefer, MD PhD, Medical University of Vienna, Department of Anesthesia, Intensive Care Medicine and Pain Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Judith Schiefer, Principal Investigator, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT05137249
• Other Study ID Numbers: EK Nr: 1590/2020
• First Posted: Nov 30, 2021
• Last Update Posted: Nov 30, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Judith Schiefer, Principal Investigator, Medical University of Vienna: glycocalyx, covid-19, ards, icu, coagulation,
• Additional relevant MeSH terms: COVID-19; Hemostatic Disorders; Blood Coagulation Disorders

Study Results

No Results Posted as of Nov 30, 2021