COVID-19NCT05185934
The Effect of Dietary Intervation on Endothelial Glycocalyx in COVID-19 Patients.
A study testing Food supplement Endocalyx in people with COVID-19 and Endothelial Dysfunction, run by University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19, Endothelial Dysfunction
- What is being tested?
- Food supplement Endocalyx
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- caucasian patients
- hospitalization for COVID-19 infection
- diagnosis of COVID-19 proven by PCR
Who cannot join
- 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
Show all 10Show fewer
- Asthma
- Chronic kidney disease (estimated glomerular filtration rate [eGFR] ≤60 ml/min/1.73 m2)
- Liver failure
- Malignancies
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
"Attikon" University General Hospital
Athens, Attica, 12462
Ignatios Ikonomidis, Professor, +302105832187, ignoik@gmail.com
Aikaterini Kountouri, MD, +302105832187, KaterinaK90@hotmail.com
About this study
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.
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.
Read the 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.
- Conditions
- COVID-19, Endothelial Dysfunction
- Being tested
- Food supplement Endocalyx, Placebo
- Keywords
- COVID-19, Arterial Stiffness, Endothelial Glycocalyx, Coronary microcirculation, Left ventricular myocardial deformation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplement EndocalyxDietary supplement
Patients with COVID-19 infection will be randomized to receive food supplement Endocalyx for 4 months.
PlaceboDietary supplement
Patients with COVID-19 infection will be randomized to receive placebo for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Food supplement Endocalyx | Active comparator | Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the food supplement Endocalyx for 4 months. Receives: Dietary Supplement: Food supplement Endocalyx |
| Placebo | Placebo comparator | Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the placebo for 4 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: four months
Secondary outcomes (3)
Endocalyx effects on arterial stiffness
Endocalyx effects on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.
Measured: 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.
Measured: 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.
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jun 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignatios Ikonomidis, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185934
- Sponsor's protocol ID
- 668/30-11-2021
- Status last verified
- May 2023
- First submitted
- 9 Jan 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pavlidis G, Kountouri A, Katogiannis K, Thymis J, Nikolaou PE, Chania C, Karalis J, Kostelli G, Michalopoulou E, Katsanaki E, Parissis J, Vink H, Long R, Tsiodras S, Lambadiari V, Ikonomidis I. Effects of 4-month treatment with glycocalyx dietary supplement on endothelial glycocalyx and vascular function after COVID-19 infection. Eur J Clin Invest. 2025 Jul;55(7):e70058. doi: 10.1111/eci.70058. Epub 2025 Apr 24.
PubMed 40270280
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05185934
- Acronym / sponsor ID
- 668/30-11-2021
- Conditions
- COVID-19, Endothelial Dysfunction
- Keywords
- COVID-19, Arterial Stiffness, Endothelial Glycocalyx, Coronary microcirculation, Left ventricular myocardial deformation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Food supplement Endocalyx | Active comparator | Dietary Supplement: Food supplement EndocalyxThirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the food supplement Endocalyx for 4 months. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the placebo for 4 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- caucasian patients
- hospitalization for COVID-19 infection
- diagnosis of COVID-19 proven by PCR
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food supplement EndocalyxPatients with COVID-19 infection will be randomized to receive food supplement Endocalyx for 4 months. | Dietary supplement | Food supplement Endocalyx |
| PlaceboPatients with COVID-19 infection will be randomized to receive placebo for 4 months. | Dietary supplement | Placebo |
Primary outcome
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
3 secondary outcomes
Endocalyx effects on arterial stiffness
Time frame: four months
Endocalyx effects on coronary microcirculation
Time frame: four months
Endocalyx effects on left ventricular myocardial function
Time frame: four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 40270280Pavlidis G, Kountouri A, Katogiannis K, Thymis J, Nikolaou PE, Chania C, Karalis J, Kostelli G, Michalopoulou E, Katsanaki E, Parissis J, Vink H, Long R, Tsiodras S, Lambadiari V, Ikonomidis I. Effects of 4-month treatment with glycocalyx dietary supplement on endothelial glycocalyx and vascular function after COVID-19 infection. Eur J Clin Invest. 2025 Jul;55(7):e70058. doi: 10.1111/eci.70058. Epub 2025 Apr 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food supplement Endocalyx in people with COVID-19 and Endothelial Dysfunction, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ignatios Ikonomidis, Professor (+302105832187, ignoik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endocalyx effects on endothelial glycocalyx thickness (time frame: four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05185934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.