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

National and Kapodistrian University of Athens

Status: Enrolling

Conditions: COVID-19; Endothelial Dysfunction

Treatments: Dietary Supplement: Food supplement Endocalyx; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05185934

668/30-11-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Food supplement Endocalyx

Active Comparator group

Description:

Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the food supplement Endocalyx for 4 months.

Treatment:

Dietary Supplement: Food supplement Endocalyx

Placebo

Placebo Comparator group

Description:

Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the placebo for 4 months.

Treatment:

Dietary Supplement: Placebo