Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-28 @ 1:14 AM
Study NCT ID:
NCT05017493
Status:
COMPLETED
Last Update Posted:
2021-12-02
First Post:
2021-04-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Covid-19 With a Herbal Compound, Xagrotin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mailto:danaomar1979@gmail.com', 'phone': '+9647701586707', 'title': 'Dr. Dara Omer', 'organization': 'Hiwa Hospital - KRG'}, 'certainAgreement': {'otherDetails': 'All PIs discuss or publish the results only according to a prior agreement with the sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 Days', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm', 'description': 'Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.\n\nXagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care', 'otherNumAtRisk': 483, 'deathsNumAtRisk': 483, 'otherNumAffected': 113, 'seriousNumAtRisk': 483, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'Patients in the Control arm received the standard of care for Covid19.', 'otherNumAtRisk': 178, 'deathsNumAtRisk': 178, 'otherNumAffected': 15, 'seriousNumAtRisk': 178, 'deathsNumAffected': 10, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Diarrhea', 'notes': 'Participants got Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 113, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'notes': 'Participants got flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 113, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Xagrotin', 'notes': 'Xagrotin is a herbal compound, and it contains flavonoids, phenols, etc., which dilate blood vessels. Therefore, the risk of internal bleeding is higher in people who take high-dose vasodilators and high-dose Xagrotin at the same time.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2.3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.\n\nXagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Patients in the Control arm received the standard of care for Covid19.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Number of Participants who died by day 30 after the enrollment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Disease From Beginning of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.\n\nXagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Patients in the Control arm received the standard of care for Covid19.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Number of days the patient has experienced the symptoms', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.\n\nXagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Patients in the Control arm received the standard of care for Covid19.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Number of participants who have been hospitalized for Covid-19', 'unitOfMeasure': 'Participatnts', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Hospitalization When Occurred', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.\n\nXagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Patients in the Control arm received the standard of care for Covid19.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.56', 'spread': '4.94', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '3.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Days the participants were hospitalized', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm', 'description': 'Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.\n\nXagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'Patients in the Control arm received the standard of care for Covid19.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '483 patients enrolled in treatment arm', 'achievements': [{'groupId': 'FG000', 'numSubjects': '483'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'Treatment & Care', 'comment': '483 patients received Xagrotin', 'achievements': [{'groupId': 'FG000', 'numSubjects': '483'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'Follow up', 'comment': '483 patients were followed up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '483'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'Mortality Check', 'comment': '483 patients were checked for mortality', 'achievements': [{'groupId': 'FG000', 'numSubjects': '483'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'comment': '361 patients completed pr protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All adult patients in an outpatient setting who were confirmed as coronavirus patients were eligible to be included in the study.', 'preAssignmentDetails': 'Age 18 or higher, Newly diagnosed (no longer than 10 days), PCR or clinically confirmed Covid-19'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '661', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm', 'description': 'Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.\n\nXagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'Patients in the Control arm received the standard of care for Covid19.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '397', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '547', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '17.16', 'groupId': 'BG000'}, {'value': '44.297', 'spread': '17.16', 'groupId': 'BG001'}, {'value': '44.1', 'spread': '17.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '483', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '661', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Iraq', 'categories': [{'measurements': [{'value': '483', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '661', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Both paitients who received and NOT received Xagrotin'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-30', 'size': 512482, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-30T09:30', 'hasProtocol': True}, {'date': '2021-11-30', 'size': 505317, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-30T09:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 661}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-30', 'studyFirstSubmitDate': '2021-04-04', 'resultsFirstSubmitDate': '2021-09-21', 'studyFirstSubmitQcDate': '2021-08-16', 'lastUpdatePostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-30', 'studyFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Number of Participants who died by day 30 after the enrollment'}], 'secondaryOutcomes': [{'measure': 'Duration of Disease From Beginning of Treatment', 'timeFrame': '30 days', 'description': 'Number of days the patient has experienced the symptoms'}, {'measure': 'Hospitalization', 'timeFrame': '30 days', 'description': 'Number of participants who have been hospitalized for Covid-19'}, {'measure': 'Duration of Hospitalization When Occurred', 'timeFrame': '30 days', 'description': 'Days the participants were hospitalized'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This is an interventional, multi-center, randomized study. Adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited (n=361). Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.', 'detailedDescription': 'This is an interventional, multi-center, randomized study that has been performed in an outpatient setting (n=361). Adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited. Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events were registered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or higher\n* Newly diagnosed (no longer than 10 days)\n* PCR or clinically confirmed Covid-19\n\nExclusion Criteria:\n\n* Severe pulmonary disease\n* Severe cardiovascular disease\n* Severe hepatic disease\n* Severe renal disease\n* Diabetes mellitus type one\n* Metabolic acidosis\n* Oxygen saturation \\<70%\n* Pregnancy\n* Breast feeding\n* Concomitant treatment with anticoagulation drugs\n* Concomitant treatment with CYP3A4 medicines with narrow therapeutic window'}, 'identificationModule': {'nctId': 'NCT05017493', 'briefTitle': 'Treatment of Covid-19 With a Herbal Compound, Xagrotin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biomad AS'}, 'officialTitle': 'Treatment of Early-Stage Covid-19 With a Herbal Compound, Xagrotin', 'orgStudyIdInfo': {'id': '02-032021-SULXAG/NO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.', 'interventionNames': ['Combination Product: Xagrotin']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Patients in the Control arm received the standard of care for Covid19.'}], 'interventions': [{'name': 'Xagrotin', 'type': 'COMBINATION_PRODUCT', 'description': 'A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sulaymaniyah', 'country': 'Iraq', 'facility': 'Directorate of health of Sulaimani, Iraq -KRG', 'geoPoint': {'lat': 35.56496, 'lon': 45.4329}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomad AS', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Directorate of Health of Sulaimani, Iraq', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}