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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05185934
Recruitment Status : Recruiting
First Posted : January 11, 2022
Last Update Posted : August 5, 2022
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : June 1, 2022
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Endocalyx effects on endothelial glycocalyx thickness [ Time Frame: 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 :
  1. Endocalyx effects on arterial stiffness [ Time Frame: four months ]
    Endocalyx effects on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.

  2. Endocalyx effects on coronary microcirculation [ Time Frame: 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.

  3. Endocalyx effects on left ventricular myocardial function [ Time Frame: four months ]
    Endocalyx effects on left ventricular function as assessed by global longitudinal strain using speckle-tracking echocardiography.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05185934


Contacts
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Contact: Ignatios Ikonomidis, Professor +302105832187 ignoik@gmail.com
Contact: Aikaterini Kountouri, MD +302105832187 KaterinaK90@hotmail.com

Locations
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Greece
"Attikon" University General Hospital Recruiting
Athens, Attiki, Greece, 12462
Contact: Ignatios Ikonomidis, Professor    +302105832187    ignoik@gmail.com   
Contact: Aikaterini Kountouri, MD    +302105832187    KaterinaK90@hotmail.com   
Sponsors and Collaborators
University of Athens
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Responsible Party: Ignatios Ikonomidis, Professor of Cardiology, University of Athens
ClinicalTrials.gov Identifier: NCT05185934    
Other Study ID Numbers: 668/30-11-2021
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ignatios Ikonomidis, University of Athens:
COVID-19
Arterial Stiffness
Endothelial Glycocalyx
Coronary microcirculation
Left ventricular myocardial deformation
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases