Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
Study NCT ID:
NCT05185934
Status:
UNKNOWN
Last Update Posted:
2023-05-16
First Post:
2022-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Dietary Intervation on Endothelial Glycocalyx in COVID-19 Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sixty patients with COVID-19 infection will be randomized to receive food supplement Endocalyx (n=30) or placebo (n=30) for 4 consecutive months.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-14', 'studyFirstSubmitDate': '2022-01-09', 'studyFirstSubmitQcDate': '2022-01-09', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endocalyx effects on endothelial glycocalyx thickness', 'timeFrame': 'four months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Endocalyx effects on arterial stiffness', 'timeFrame': 'four months', 'description': 'Endocalyx effects on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.'}, {'measure': 'Endocalyx effects on coronary microcirculation', 'timeFrame': 'four months', 'description': '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.'}, {'measure': 'Endocalyx effects on left ventricular myocardial function', 'timeFrame': 'four months', 'description': 'Endocalyx effects on left ventricular function as assessed by global longitudinal strain using speckle-tracking echocardiography.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Arterial Stiffness', 'Endothelial Glycocalyx', 'Coronary microcirculation', 'Left ventricular myocardial deformation'], 'conditions': ['COVID-19', 'Endothelial Dysfunction']}, 'referencesModule': {'references': [{'pmid': '40270280', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* caucasian patients\n* hospitalization for COVID-19 infection\n* diagnosis of COVID-19 proven by PCR\n\nExclusion Criteria:\n\n* Pregnancy and breastfeeding\n* Foreseen inability to attend scheduled visits\n* History of acute coronary syndrome. Coronary artery disease will be excluded by a clinical history, examination and electrocardiogram.\n* Moderate or severe valve disease\n* Primary cardiomyopathies\n* Chronic obstructive pulmonary disease\n* Asthma\n* Chronic kidney disease (estimated glomerular filtration rate \\[eGFR\\] ≤60 ml/min/1.73 m2)\n* Liver failure\n* Malignancies'}, 'identificationModule': {'nctId': 'NCT05185934', 'briefTitle': 'The Effect of Dietary Intervation on Endothelial Glycocalyx in COVID-19 Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '668/30-11-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Food supplement Endocalyx', 'description': 'Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the food supplement Endocalyx for 4 months.', 'interventionNames': ['Dietary Supplement: Food supplement Endocalyx']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the placebo for 4 months.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Food supplement Endocalyx', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients with COVID-19 infection will be randomized to receive food supplement Endocalyx for 4 months.', 'armGroupLabels': ['Food supplement Endocalyx']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients with COVID-19 infection will be randomized to receive placebo for 4 months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12462', 'city': 'Athens', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Ignatios Ikonomidis, Professor', 'role': 'CONTACT', 'email': 'ignoik@gmail.com', 'phone': '+302105832187'}, {'name': 'Aikaterini Kountouri, MD', 'role': 'CONTACT', 'email': 'KaterinaK90@hotmail.com', 'phone': '+302105832187'}], 'facility': '"Attikon" University General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Ignatios Ikonomidis, Professor', 'role': 'CONTACT', 'email': 'ignoik@gmail.com', 'phone': '+302105832187'}, {'name': 'Aikaterini Kountouri, MD', 'role': 'CONTACT', 'email': 'KaterinaK90@hotmail.com', 'phone': '+302105832187'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Cardiology', 'investigatorFullName': 'Ignatios Ikonomidis', 'investigatorAffiliation': 'University of Athens'}}}}