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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-01-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19 Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Food supplement Endocalyx

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Food supplement Endocalyx

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No