Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT04723459
Status:
UNKNOWN
Last Update Posted:
2021-03-17
First Post:
2021-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Nano-Ivermectin Impregnated Masks in Prevention of Covid-19 Among Healthy Contacts and Medical Staff
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sequential Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2021-01-20', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of persons in each group who Complain of any suspected Symptoms', 'timeFrame': 'within 14 days after enrollement', 'description': '( Fever, Myalgia ,Cough, Sore Throat, Diarrhea, Shortness of Breath)'}], 'secondaryOutcomes': [{'measure': 'Number of persons in each group who are diagnosed as COVID-19 patients', 'timeFrame': 'within 21 days after enrollement', 'description': 'swab test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'antiviral mask', 'nano ivermectin'], 'conditions': ['Covid-19']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://druginfo.nlm.nih.gov/drugportal/name/Ivermectin', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Antiviral efficacy of Ivermectin against Covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano Ivermectin solution will theoretically increase the protective action of the ordinary masks', 'detailedDescription': 'Antiviral effecacy of Ivermectin against Covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano Ivermectin solution will theoretically increase the protective action of the ordinary masks this study is a trial for evaluation of adding a proved antiviral material to the mask and to compare between the protective value of this mask and the ordinary one.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* health care personells and family contact of confirmed COVID-19 cases.\n\nExclusion Criteria:\n\n* refusal of participate to use the masks.\n* pregnancy or lactation known hypersensitivity to ivermectin.'}, 'identificationModule': {'nctId': 'NCT04723459', 'briefTitle': 'Efficacy of Nano-Ivermectin Impregnated Masks in Prevention of Covid-19 Among Healthy Contacts and Medical Staff', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Nano-Ivermectin Impregnated Masks Versus Ordinary Surgical Masks in Prevention of Covid-19 Among Healthy Contacts and Medical Staff', 'orgStudyIdInfo': {'id': 'SVU MED CIT0 23 4 21 1 121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ivermectin mask group', 'description': 'Contacts who will use ivermectin masks', 'interventionNames': ['Other: ivermectin impregnated mask']}, {'type': 'NO_INTERVENTION', 'label': 'ordinary mask group', 'description': 'Contacts who will use regular masks'}], 'interventions': [{'name': 'ivermectin impregnated mask', 'type': 'OTHER', 'description': 'mask with ivermectin nano solution', 'armGroupLabels': ['Ivermectin mask group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83511', 'city': 'Qina', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Zaky Aref', 'role': 'CONTACT', 'email': 'doctor.aref@hotmail.com', 'phone': '01001771210', 'phoneExt': '002'}], 'facility': 'Zaky Aref', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'centralContacts': [{'name': 'Zaky Aref', 'role': 'CONTACT', 'email': 'doctor.aref@hotmail.com', 'phone': '+201001771210'}, {'name': 'mohammed hosny hassaan', 'role': 'CONTACT', 'email': 'mohammedhosnyhassaan@yahoo.com', 'phone': '01115390073', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ass.professor', 'investigatorFullName': 'Zaky Aref', 'investigatorAffiliation': 'South Valley University'}}}}