The Effect of Dietary Intervation on Endothelial Glycocalyx in COVID-19 Patients.

The Effect of Dietary Glycocalyx Precursor Supplementation on Endothelial Function, on Markers of Vascular Function and on Cardiac Performance in Patients With COVID-19 Infection.

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Endothelial Dysfunction
• Intervention / Treatment: Dietary supplement: Food supplement Endocalyx; Dietary supplement: Placebo

Detailed Description

Sixty patients who have been hospitalized due to COVID-19 infection will be randomized to receive food supplement Endocalyx (4 capsules per day) (n=30) or placebo (n=30) for 4 consecutive months.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ignatios Ikonomidis, Professor; Phone Number: +302105832187; Email: ignoik@gmail.com
• Study Contact Backup: Name: Aikaterini Kountouri, MD; Phone Number: +302105832187; Email: KaterinaK90@hotmail.com

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 12462
      • Recruiting
      • "ATTIKON" University General Hospital
      • Contact: Ignatios Ikonomidis, Professor; Phone Number: +302105832187; Email: ignoik@gmail.com
      • Contact: Aikaterini Kountouri, MD; Phone Number: +302105832187; Email: KaterinaK90@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Food supplement Endocalyx; 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; Patients with COVID-19 infection will be randomized to receive food supplement Endocalyx for 4 months.
Placebo Comparator: Placebo; Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the placebo for 4 months.	Dietary supplement: Placebo; Patients with COVID-19 infection will be randomized to receive placebo for 4 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endocalyx effects on arterial stiffness	Endocalyx effects on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.	four months
Endocalyx effects on left ventricular myocardial function	Endocalyx effects on left ventricular function as assessed by global longitudinal strain using speckle-tracking echocardiography.	four months
Endocalyx effects on coronary microcirculation	Endocalyx effects on coronary function as assessed by measuring coronary flow reserve of left anterior descending artery. Coronary flow reserve is estimated by Doppler echocardiography as the ratio of coronary flow velocity (m/s) after bolus intravenous adenosine infusion to coronary flow velocity (m/s) at rest.	four months

Collaborators and Investigators

• Sponsor: University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): January 30, 2024

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: January 9, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 14, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Arterial Stiffness; Coronary microcirculation; Endothelial Glycocalyx; Left ventricular myocardial deformation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 668/30-11-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No