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

University of Athens60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

COVID-19 Endothelial Dysfunction

Interventions

Food supplement EndocalyxDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

"Attikon" University General Hospital

Athens, Attica, Greece

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: four months

Secondary Outcomes

Endocalyx effects on arterial stiffness

Endocalyx effects on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.

Time frame: 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.

Time frame: 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.

Time frame: four months

Central Contacts

Ignatios Ikonomidis, Professor

CONTACT

+302105832187 ignoik@gmail.com

Aikaterini Kountouri, MD

CONTACT

+302105832187 KaterinaK90@hotmail.com

Data from ClinicalTrials.gov

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