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

Sponsor

University of Athens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05185934

Collaborator

(none)

Enrollment

Location

Arms

12.9

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Endothelial Dysfunction	Dietary Supplement: Food supplement Endocalyx Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Sixty patients with COVID-19 infection will be randomized to receive food supplement Endocalyx (n=30) or placebo (n=30) for 4 consecutive months.Sixty patients with COVID-19 infection will be randomized to receive food supplement Endocalyx (n=30) or placebo (n=30) for 4 consecutive months.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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.

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Endocalyx effects on endothelial glycocalyx thickness [four months]
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

Secondary Outcome Measures

Endocalyx effects on arterial stiffness [four months]
Endocalyx effects on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.
Endocalyx effects on coronary microcirculation [four months]
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.
Endocalyx effects on left ventricular myocardial function [four months]
Endocalyx effects on left ventricular function as assessed by global longitudinal strain using speckle-tracking echocardiography.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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