NCT05185934

Brief Summary

The food supplement Endocalyx is considered to support the endothelial glycocalyx integrity by supplying sulfated polysaccharides, anti-oxidant enzymes and additional substrates for glycocalyx synthesis. The investigators will study the effect of Endocalyx on endothelial, vascular and left ventricular myocardial function in patients with COVID-19 infection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

January 9, 2022

Last Update Submit

May 14, 2023

Conditions

COVID-19Endothelial Dysfunction

Keywords

COVID-19Arterial StiffnessEndothelial GlycocalyxCoronary microcirculationLeft ventricular myocardial deformation

Outcome Measures

Primary Outcomes (1)

  • Endocalyx effects on endothelial glycocalyx thickness

    Endocalyx effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels using Sidestream Dark Field (SDF) imaging

    four months

Secondary Outcomes (3)

  • Endocalyx effects on arterial stiffness

    four months

  • Endocalyx effects on coronary microcirculation

    four months

  • Endocalyx effects on left ventricular myocardial function

    four months

Study Arms (2)

Food supplement Endocalyx

ACTIVE COMPARATOR

Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the food supplement Endocalyx for 4 months.

Dietary Supplement: Food supplement Endocalyx

Placebo

PLACEBO COMPARATOR

Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the placebo for 4 months.

Dietary Supplement: Placebo

Interventions

Food supplement EndocalyxDIETARY_SUPPLEMENT

Patients with COVID-19 infection will be randomized to receive food supplement Endocalyx for 4 months.

Food supplement Endocalyx
PlaceboDIETARY_SUPPLEMENT

Patients with COVID-19 infection will be randomized to receive placebo for 4 months.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • caucasian patients
  • hospitalization for COVID-19 infection
  • diagnosis of COVID-19 proven by PCR

You may not qualify if:

  • Pregnancy and breastfeeding
  • Foreseen inability to attend scheduled visits
  • History of acute coronary syndrome. Coronary artery disease will be excluded by a clinical history, examination and electrocardiogram.
  • Moderate or severe valve disease
  • Primary cardiomyopathies
  • Chronic obstructive pulmonary disease
  • Asthma
  • Chronic kidney disease (estimated glomerular filtration rate \[eGFR\] ≤60 ml/min/1.73 m2)
  • Liver failure
  • Malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Attikon" University General Hospital

Athens, Attica, 12462, Greece

RECRUITING

Related Publications (1)

  • Pavlidis G, Kountouri A, Katogiannis K, Thymis J, Nikolaou PE, Chania C, Karalis J, Kostelli G, Michalopoulou E, Katsanaki E, Parissis J, Vink H, Long R, Tsiodras S, Lambadiari V, Ikonomidis I. Effects of 4-month treatment with glycocalyx dietary supplement on endothelial glycocalyx and vascular function after COVID-19 infection. Eur J Clin Invest. 2025 Jul;55(7):e70058. doi: 10.1111/eci.70058. Epub 2025 Apr 24.

    PMID: 40270280DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Ignatios Ikonomidis, Professor

CONTACT

+302105832187ignoik@gmail.com

Aikaterini Kountouri, MD

CONTACT

+302105832187KaterinaK90@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Sixty patients with COVID-19 infection will be randomized to receive food supplement Endocalyx (n=30) or placebo (n=30) for 4 consecutive months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology

Study Record Dates

First Submitted

January 9, 2022

First Posted

January 11, 2022

Study Start

June 1, 2022

Primary Completion

November 1, 2023

Study Completion

January 30, 2024

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)