Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT04716569
Status:
UNKNOWN
Last Update Posted:
2021-03-17
First Post:
2021-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Ivermectin Mucoadhesive Nanosuspension as Nasal Spray in Management of Early Covid-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-04-02', 'releaseDate': '2021-03-26'}], 'estimatedResultsFirstSubmitDate': '2021-03-26'}}, '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-19', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression of covid 19 clinical picture', 'timeFrame': '[ Time Frame: within 14 days after enrollement ]', 'description': 'progress of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)with radiological assesment and blood tests'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ivermectin intranasal spray in covid19'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '34163159', 'type': 'DERIVED', 'citation': 'Aref ZF, Bazeed SEES, Hassan MH, Hassan AS, Rashad A, Hassan RG, Abdelmaksoud AA. Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19. Int J Nanomedicine. 2021 Jun 15;16:4063-4072. doi: 10.2147/IJN.S313093. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Ivermectin showed a strong viricidal effect upon covid19 virus in vitro as proved by many authors according to many studies , covid virus stay in postnasal space for 4 days before starting general manifestation, so ivermectin mucoadhesive nanosuspension sprayed inside the nose and post nasal space may help in early management of covid19 and may play a great rule in prophylaxis as well', 'detailedDescription': '150 patient with early covid is devided into two groups first group will receive regular protocol of drugs second group will receive ivermectin nasal spray in addition to regular protocl of drugs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* early covid19 pateints\n\nExclusion Criteria:\n\n* children and pregnant women'}, 'identificationModule': {'nctId': 'NCT04716569', 'briefTitle': 'Evaluation of Ivermectin Mucoadhesive Nanosuspension as Nasal Spray in Management of Early Covid-19', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Faculty of Medicine ,South Valley University', 'orgStudyIdInfo': {'id': 'SVU MED CIT0 23 4 21 1 120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intranasal Ivermectin group', 'description': 'Ivermectin group Patients who will receive intranasal ivermectin', 'interventionNames': ['Drug: intranasal ivermectin spray']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'patients who will receive regular protocol drugs', 'interventionNames': ['Drug: intranasal ivermectin spray']}], 'interventions': [{'name': 'intranasal ivermectin spray', 'type': 'DRUG', 'description': 'usage of ivermectin as intranasal spray for treating early covid patiens', 'armGroupLabels': ['Control group', 'intranasal Ivermectin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83511', 'city': 'Qina', 'state': 'Qena Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Zaky Aref, MD', 'role': 'CONTACT', 'email': 'doctor.aref@hotmail.com', 'phone': '01001771210'}, {'name': 'mohammed hosny hassaan, MD', 'role': 'CONTACT', 'email': 'mohammedhosnyhassaan@yahoo.com', 'phone': '00201115390073'}], 'facility': 'Zaky Aref', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ass.professor', 'investigatorFullName': 'Zaky Aref', 'investigatorAffiliation': 'South Valley University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-03-26', 'type': 'RELEASE'}, {'date': '2021-04-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Zaky Aref, ass.professor, South Valley University'}}}}