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

Study Overview
=================
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.

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.

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.

Conditions
-----------------
COVID-19, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Dietary Supplement: Food supplement Endocalyx
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Arterial Stiffness, Endothelial Glycocalyx, Coronary microcirculation, Left ventricular myocardial deformation