Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT04871802
Status:
UNKNOWN
Last Update Posted:
2021-05-04
First Post:
2021-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID-19 Pneumonia
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-01', 'studyFirstSubmitDate': '2021-03-21', 'studyFirstSubmitQcDate': '2021-05-01', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamics of spirometry indices', 'timeFrame': 'In 2 months after recruitment', 'description': 'spirometry'}, {'measure': 'Dynamics of ECHO CG', 'timeFrame': 'In 2 months after recruitment', 'description': 'ECHO CG'}, {'measure': 'Dynamics of pulse wave velocity', 'timeFrame': 'In 2 months after recruitment', 'description': 'applanation tonometry'}, {'measure': 'Dynamics of augmentation index', 'timeFrame': 'In 2 months after recruitment', 'description': 'applanation tonometry'}], 'secondaryOutcomes': [{'measure': 'Dynamics of biological age', 'timeFrame': 'In 2 months after recruitment', 'description': 'Laboratory indicators'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Objective of the study is to evaluate the effect of Taxifolin Aqua therapy on the indicators of respiratory function, the state of the arterial wall, the contractile function of the myocardium, as well as to assess the effect of Taxifolin Aqua therapy on markers of biological age, quality of patients life.', 'detailedDescription': 'The study will include 100 patients who had covid pneumonia 3 months ago. If the inclusion / exclusion criteria are met, the patient is asked to sign an informed consent to participate in the study. Consenting patients are randomized to an intervention group or a control group. The control group (n = 50) will receive standard therapy, patients from the intervention group (n = 50) will be prescribed Taxifolin Aqua 30 mg per day in addition to standard therapy. Patients will be randomized to the control and main group using random number spreadsheets, assuming that the control and main groups will be homogeneous in the main demographic and clinical parameters. Patient monitoring will be carried out within 2 months from the date of inclusion. A follow-up visit is scheduled in 2 months. During the study, the patient will be regularly monitored for tolerance and safety of therapy with Taxifolin Aqua.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients of both sexes who had covid pneumonia 3 months ago and signed an informed consent and aged 18+.\n\nExclusion Criteria:\n\nStandard contraindications to Taxifolin Aqua use.'}, 'identificationModule': {'nctId': 'NCT04871802', 'briefTitle': 'Effect of the Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID-19 Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Pirogov Russian National Research Medical University'}, 'officialTitle': 'A Prospective, Randomized, Comparative Study in Two Groups to Assess the Effect of the Use of a Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID Pneumonia and on the Biological Age', 'orgStudyIdInfo': {'id': 'COVID-AQUA-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Taxifolin Aqua group', 'description': 'Taxifolin Aqua 30 mg per day in addition to standard therapy', 'interventionNames': ['Dietary Supplement: Taxifolin Aqua']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No intervention'}], 'interventions': [{'name': 'Taxifolin Aqua', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary supplement', 'armGroupLabels': ['Taxifolin Aqua group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '129226', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Russian Clinical Research Center for Gerontology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Irina Strazhesko, MD, PhD', 'role': 'CONTACT', 'email': 'Istrazhesko@gmail.com'}, {'name': 'Olga Tkacheva, MD, PhD', 'role': 'CONTACT', 'email': 'rgnkc@rgnkc.ru', 'phone': '+74991871254'}], 'overallOfficials': [{'name': 'Irina Strazhesko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Reserach Center for Gerontology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pirogov Russian National Research Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}