Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-28 @ 1:59 AM
Study NCT ID:
NCT05463393
Status:
SUSPENDED
Last Update Posted:
2025-07-01
First Post:
2022-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Xanthohumol as an Adjuvant Therapy in Critically Ill COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients were randomized in a double-blind, placebo-controlled fashion into two groups using sealed envelopes'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'whyStopped': 'We are waiting for the additional founds.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2022-07-15', 'studyFirstSubmitQcDate': '2022-07-15', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Xanthohumol reduces coronavirus-induced inflammatory response', 'timeFrame': 'one week after regular supplementation', 'description': 'Xanthohumol possesses strong anti-inflammatory properties. It can reduce the production and secretion of pro-inflammatory cytokines. Additionally, it inhibits inflammatory-induced endothelial dysregulation and exerting antiangiogenic and anti-inflammatory effects.'}, {'measure': 'Xanthohumol improves clinical course in critically ill COVID-19 patients', 'timeFrame': '28 days mortality', 'description': 'Reduction the severity of inflammatory response should affect clinical course. Strong anti-inflammatory treatment can reduce a risk of poor outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Respiratory Infection']}, 'descriptionModule': {'briefSummary': 'It has been well documented that coronavirus COVID-19 disease is associated with massive inflammatory response and cytokine storm. Several medications have been used to ameliorate COVID-19-related inflammation. Xanthohumol, a natural medication extracted from hop cones, possesses strong anti-inflammatory properties and can reduce the severity of inflammatory response. The aim of this study is to analyze the effect of Xanthohumol on clinical course, inflammatory response and outcome in patients admitted to the ICU due to COVID-related acute respiratory failure with an oxygenation index (PaO2/FiO2) less than 150.', 'detailedDescription': 'Xanthohumol inhibits proinflammatory pathways in different independent mechanisms. Ir inhibits farnesoid X receptor activity, and reduces the synthesis and release of different proinflammatory cytokines such as IL-1β, IL-6, IL-8, IL-12p70, TNFα and interferon γ. The pathomechanism of its anti-inflammatory activity is associated with the suppression of nuclear factor-kappa B. Additionally, Xanthohumol inhibits inflammatory-induced endothelial disorders, which are associated with an improvement in blood velocity and a reduction in the risk of arterial thrombosis, especially in pulmonary arteries. An increase in proinflammatory release, known as cytokine storm, as well as increased incidences of vascular thrombosis, are observed in coronavirus infection. Hence, Xanthohumol may reduce the severity of the clinical course in COVID-19 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of COVID-19 with acute respiratory failure (PaO2/FiO2 below 150).\n\nExclusion Criteria:\n\nHistory of chronic cardiovascular, liver or/and kidney diseases. History of chronic pulmonary diseases with prolonged oxygen supplementation or domestic mechanical ventilation.\n\nPregnant women, Neoplastic diseases, Immunologic diseases Patients received immunomodulatory treatment.'}, 'identificationModule': {'nctId': 'NCT05463393', 'briefTitle': 'Xanthohumol as an Adjuvant Therapy in Critically Ill COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lublin'}, 'officialTitle': 'Humulus Lupus Extract Rich in Xanthohumol Improves Clinical Course in Critically Ill COVID-19 Patients', 'orgStudyIdInfo': {'id': 'DS352/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Xn', 'description': 'Patients who received extract from Humulus lupus L rich in Xanthohumol (Hop-RXn™, BioActive-Tech Ltd, Lublin, Poland; http://xanthohumol.com.pl/) as an adjuvant therapy. Based on pharmacokinetics and bioactivity, Xn was administered enterally three times a day every 8 hours at a dose of 1.5 mg/kg body weight (4.5 mg/kg body weight/day) for 7 days. The first dose of Xn was administered within 4 hours after admission to the ICU.', 'interventionNames': ['Biological: Xanthohumol - prenylated chalcone extracted from female inflorescences of hop cones (Humulus lupus). Hop-RXn™, BioActive-Tech Ltd, Lublin, Poland; http://xanthohumol.com.pl/']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C', 'description': 'Patients who received 0.9% NaCl at the oral volume 1 mL (similar to Xn volume) three times a day every 8 hours. The first dose of Xn was administered within 4 hours after admission to the ICU.', 'interventionNames': ['Biological: Xanthohumol - prenylated chalcone extracted from female inflorescences of hop cones (Humulus lupus). Hop-RXn™, BioActive-Tech Ltd, Lublin, Poland; http://xanthohumol.com.pl/']}], 'interventions': [{'name': 'Xanthohumol - prenylated chalcone extracted from female inflorescences of hop cones (Humulus lupus). Hop-RXn™, BioActive-Tech Ltd, Lublin, Poland; http://xanthohumol.com.pl/', 'type': 'BIOLOGICAL', 'description': 'The appropriate dose of Xanthohumol was solved in 1 mL of propylene glycol', 'armGroupLabels': ['Group C', 'Group Xn']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20-059', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Medical University of Lublin', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}], 'overallOfficials': [{'name': 'Andrzej Stepulak, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rector of the Medical University of Lublin, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lublin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof MD PhD, Head of Chair and First Department of Anaesthesiology and Intensive Therapy', 'investigatorFullName': 'Wojciech Dąbrowski', 'investigatorAffiliation': 'Medical University of Lublin'}}}}