The Glycocalyx in COVID-19 Patients. A Pilot Study | NCT05137249

Studies
The Glycocalyx in COVID-19 Patients. A Pilot Study

NCT05137249

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Nov 30, 2021Actual

Enrollment

30Actual

Phase

Not provided

Conditions

COVID-19
Endothelial Dysfunction
Coagulation Disorder

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Mar 1, 2021Actual

Completion Date

May 1, 2021Actual

First Submitted Date

Nov 24, 2021

First Submission Date that Met QC Criteria

Nov 24, 2021

First Posted Date

Nov 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2021

Last Update Posted Date

Nov 30, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Judith Schiefer, Principal Investigator, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

refusal of study participation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Judith Schiefer, MD PhD	Medical University of Vienna, Department of Anesthesia, Intensive Care Medicine and Pain Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna		Vienna			Austria

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D020141	Hemostatic Disorders
D055371	Acute Lung Injury
D013927	Thrombosis

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided