Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-27 @ 4:15 PM
Study NCT ID:
NCT04422561
Status:
COMPLETED
Last Update Posted:
2020-08-27
First Post:
2020-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prophylactic Ivermectin in COVID-19 Contacts
Sponsor:
Organization:
Raw JSON
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0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Contacts who will be only observed without prophylaxis', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'tingling/numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'heart burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'sleepiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ivermectin Group', 'description': 'Contacts who will receive prophylactic ivermectin\n\nIvermectin Tablets:\n\n40-60 kg (15mg/day) 60-80kg (18mg/day) \\>80kg (24mg/day)'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Contacts who will be only observed without prophylaxis'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 14 days after enrollement', 'description': 'history taking and clinical examination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Development of COVID', 'timeFrame': 'within 14 days after enrollement', 'description': 'by swab', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ivermectin Group', 'description': 'Contacts who will receive prophylactic ivermectin\n\nIvermectin Tablets:\n\n40-60 kg (15mg/day) 60-80kg (18mg/day) \\>80kg (24mg/day)'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Contacts who will be only observed without prophylaxis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '228'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ivermectin Group', 'description': 'Contacts who will receive prophylactic ivermectin\n\nIvermectin Tablets:\n\n40-60 kg (15mg/day) 60-80kg (18mg/day) \\>80kg (24mg/day)'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Contacts who will be only observed without prophylaxis'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.75', 'spread': '14.93', 'groupId': 'BG000'}, {'value': '37.69', 'spread': '16.95', 'groupId': 'BG001'}, {'value': '38.72', 'spread': '15.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-31', 'size': 1263199, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-23T16:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-23', 'studyFirstSubmitDate': '2020-06-06', 'resultsFirstSubmitDate': '2020-08-23', 'studyFirstSubmitQcDate': '2020-06-06', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-23', 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)', 'timeFrame': 'within 14 days after enrollement', 'description': 'history taking and clinical examination'}], 'secondaryOutcomes': [{'measure': 'Development of COVID', 'timeFrame': 'within 14 days after enrollement', 'description': 'by swab'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID']}, 'descriptionModule': {'briefSummary': 'asymptomatic family close contact of confirmed COVID -19 patient will receive prophylactic ivermectin and will be followed up for 14 days for any symptoms \\& diagnosis of COVID -19'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nfamily contact of confirmed COVID-19 case\n\nExclusion Criteria:\n\n* refuse to participate and receive the drug pregnancy or lactation known hypersensitivity to ivermectin'}, 'identificationModule': {'nctId': 'NCT04422561', 'briefTitle': 'Prophylactic Ivermectin in COVID-19 Contacts', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Use of Ivermectin as a Prophylactic Option in Asymptomatic Family Close Contact for Patient With COVID-19', 'orgStudyIdInfo': {'id': 'ZU-IRB#6150/31-5-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ivermectin group', 'description': 'Contacts who will receive prophylactic ivermectin', 'interventionNames': ['Drug: Ivermectin Tablets']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Contacts who will be only observed without prophylaxis'}], 'interventions': [{'name': 'Ivermectin Tablets', 'type': 'DRUG', 'description': 'two doses 72 hours apart', 'armGroupLabels': ['Ivermectin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of chest diseases', 'investigatorFullName': 'Waheed Shouman', 'investigatorAffiliation': 'Zagazig University'}}}}