Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-04-23 @ 5:48 PM
Study NCT ID:
NCT05305560
Status:
COMPLETED
Last Update Posted:
2024-12-31
First Post:
2022-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007559', 'term': 'Ivermectin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'caroline.denot@medincell.com', 'phone': '6 40 38 93 83', 'title': 'Head of Clinical Development', 'phoneExt': '0033', 'organization': 'MedinCell'}, 'certainAgreement': {'otherDetails': "The PI can present and discuss the results but publication is subject to the sponsor's prior approval", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '56 days', 'description': 'Adverse events were collected passively upon Participant declaration.', 'eventGroups': [{'id': 'EG000', 'title': 'Active IMP', 'description': 'Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 49, 'seriousNumAtRisk': 200, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo tablets: Daily placebo tablets intake for 28 days', 'otherNumAtRisk': 199, 'deathsNumAtRisk': 199, 'otherNumAffected': 109, 'seriousNumAtRisk': 199, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 109, 'numAffected': 109}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperlipidemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vertigp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dysmenorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Basophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'COVID-19 Prophylaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active IMP', 'description': 'Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablets: Daily placebo tablets intake for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'COVID-19 Symptoms Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active IMP', 'description': 'Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablets: Daily placebo tablets intake for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Number of symptomatic Participants according to the WHO COVID-18 scale', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'COVID-19 Prophylaxis Timeframe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active IMP', 'description': 'Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablets: Daily placebo tablets intake for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '8.10', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Time to change from baseline in negative RT-PCR to positive RT-PCR', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Participants who've had a positive RT-PCR during the trial"}, {'type': 'SECONDARY', 'title': 'COVID-19 Hospitalisations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active IMP', 'description': 'Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablets: Daily placebo tablets intake for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 56', 'description': 'Proportion of COVID-19 related hospitalisations', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Partcipants who had COVID-19 related hospitalisatoin episodes'}, {'type': 'SECONDARY', 'title': 'COVID-19 Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active IMP', 'description': 'Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablets: Daily placebo tablets intake for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 56', 'description': 'Proportion of COVID-19 related mortality', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who suffered a COVID-19 related death'}, {'type': 'SECONDARY', 'title': 'To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active IMP', 'description': 'Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablets: Daily placebo tablets intake for 28 days'}], 'classes': [{'title': 'Adverse events', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '56 days', 'description': 'Descriptive comparison of AE rates and severity/seriousness between IVM and placebo', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have received at least a single dose of the allocated treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active IMP', 'description': 'Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo tablets: Daily placebo tablets intake for 28 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'comment': '1 participant on placebo did not receive treatment as no kit was available on site', 'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active IMP', 'description': 'Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo tablets: Daily placebo tablets intake for 28 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.86', 'spread': '11.84', 'groupId': 'BG000'}, {'value': '39.99', 'spread': '12.03', 'groupId': 'BG001'}, {'value': '40.42', 'spread': '11.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant who was randomized to placebo did not receive treatment as the IMP Kit was not available at the site. They were not included in the analyses'}, {'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.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Bulgaria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-08', 'size': 483524, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-09T10:09', 'hasProtocol': True}, {'date': '2022-07-20', 'size': 709870, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-19T04:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2022-03-28', 'resultsFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-02', 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19 Prophylaxis', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28'}], 'secondaryOutcomes': [{'measure': 'COVID-19 Symptoms Development', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Number of symptomatic Participants according to the WHO COVID-18 scale'}, {'measure': 'COVID-19 Prophylaxis Timeframe', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Time to change from baseline in negative RT-PCR to positive RT-PCR'}, {'measure': 'COVID-19 Hospitalisations', 'timeFrame': 'From Day 1 to Day 56', 'description': 'Proportion of COVID-19 related hospitalisations'}, {'measure': 'COVID-19 Mortality', 'timeFrame': 'From Day 1 to Day 56', 'description': 'Proportion of COVID-19 related mortality'}, {'measure': 'To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days', 'timeFrame': '56 days', 'description': 'Descriptive comparison of AE rates and severity/seriousness between IVM and placebo'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prophylaxis', 'RT-PCR test'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis', 'detailedDescription': 'This trial comprises a total observation period of up to 56 days (an on-treatment period of up to 28 days and a safety follow-up of up to 28 days).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age between 18 and 65 years, inclusive.\n2. Body weight \\>45 kg.\n3. Body Mass Index \\>18.5.\n4. Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening.\n5. Only one member in the same household will be enrolled.\n6. Participants must be able to give informed consent and comply with the study's scheduled events/visits and study assessments.\n7. SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test.\n8. Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial.\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding.\n2. Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study.\n3. A positive COVID-19 result (PCR or antigen test) within 8 days of screening.\n4. Presence of typical COVID-19 symptoms (fever \\>38°C, SpO2 below 93%, dyspnoea, difficulty breathing, chills, repeated shaking with chills, ageusia, anosmia, cough, myalgia, headache) in the past 48 hours prior to screening.\n5. Hypersensitivity to any component of ivermectin.\n6. Participants who have been administered ivermectin within 30 days prior to screening.\n7. Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first.\n8. Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.).\n9. History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors.\n10. Current use of monoclonal antibodies for the treatment of COVID-19."}, 'identificationModule': {'nctId': 'NCT05305560', 'acronym': 'SAIVE', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedinCell S.A'}, 'officialTitle': 'A Multicentre Randomised, Double-Blind, Placebo-controlled, Study to Evaluate the efficAcy and Safety of Oral IVErmectin Tablets in the Prevention of COVID-19', 'orgStudyIdInfo': {'id': 'mdc-TTG-CT-002'}, 'secondaryIdInfos': [{'id': '2021-001938-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active IMP', 'interventionNames': ['Drug: Ivermectin Tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Matching placebo tablets']}], 'interventions': [{'name': 'Ivermectin Tablets', 'type': 'DRUG', 'description': 'Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.', 'armGroupLabels': ['Active IMP']}, {'name': 'Matching placebo tablets', 'type': 'DRUG', 'description': 'Daily placebo tablets intake for 28 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Medical Center Medic Ltd.', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}], 'overallOfficials': [{'name': 'Anna Kostova, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Center Medic Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedinCell S.A', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Violaine Desort-Hénin, DVM', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}