NCT05137249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

November 24, 2021

Last Update Submit

November 24, 2021

Conditions

Keywords

glycocalyx, covid-19, ards, icu, coagulation,

Outcome Measures

Primary Outcomes (1)

  • extent of endothelial damage

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

    up to 2 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed and hospitalized with COVID 19 due to clinical symptoms.

You may qualify if:

  • COVID-19 detected by PCR measures going along with clinical symptoms
  • age \> 18 years

You may not qualify if:

  • refusal of study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

COVID-19Hemostatic DisordersAcute Lung InjuryThrombosis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesLung InjuryEmbolism and Thrombosis

Study Officials

  • Judith Schiefer, MD PhD

    Medical University of Vienna, Department of Anesthesia, Intensive Care Medicine and Pain Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2021

First Posted

November 30, 2021

Study Start

December 1, 2020

Primary Completion

March 1, 2021

Study Completion

May 1, 2021

Last Updated

November 30, 2021

Record last verified: 2021-11

Locations