Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-09 @ 7:04 AM
Study NCT ID:
NCT04510233
Status:
UNKNOWN
Last Update Posted:
2020-08-12
First Post:
2020-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ivermectin Nasal Spray for COVID19 Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007559', 'term': 'Ivermectin'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2020-08-10', 'studyFirstSubmitQcDate': '2020-08-11', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCR of SARS-Cov2 RNA', 'timeFrame': '14 days', 'description': 'Negative PCR result of SARS-Cov2 RNA in COVID19 patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID19'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The global escalation of COVID19 pandemic has put the health care system under pressure with urgent need for treatment. In the absence of vaccine and approved drug against SARS-COV2 over the past 6 months, the health authorities were obliged to re-purpose existing drugs to fight this pandemic.', 'detailedDescription': 'Ivermectin is a well-known FDA-approved pan antiparasitic drug with high safety profile and potential therapeutic effects against COVID 19. It has been previously investigated as an antiviral agent. It showed 5000 fold reduction of SARS COV 2 viral RNA in-vitro studies.\n\nHowever, some researchers questioned its efficacy in the oral form as very high doses will be required to achieve a proper tissue concentration and viricidal effect in the respiratory system.\n\nOur hypothesis is that, since COVID-19 has shown to be particularly damaging to the respiratory system, using inhaled forms of Ivermectin will deliver the drug directly to the infection site and make it a treatment option.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to moderate severity who are confirmed to be positive for SARS COV 2.\n\nExclusion Criteria:\n\n* patients with severe form of COVID-19 or those who are on ventilatory support or those with cytokine storm'}, 'identificationModule': {'nctId': 'NCT04510233', 'briefTitle': 'Ivermectin Nasal Spray for COVID19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Ivermectin Inhalation Forms in the Management of COVID-19 Egyptian Patients', 'orgStudyIdInfo': {'id': 'IvrInh'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ivermectin nasal spray', 'description': 'Ivermectin administered as nasal spray (one ml in each nostril two times daily)', 'interventionNames': ['Drug: Ivermectin nasal']}, {'type': 'EXPERIMENTAL', 'label': 'Ivermectin oral', 'description': 'Ivermectin administered orally (one tablet 6 mg three times daily) for 72 hours plus the standard care of COVID-19 cases.', 'interventionNames': ['Drug: Ivermectin oral']}, {'type': 'EXPERIMENTAL', 'label': 'standard care', 'description': 'COVID-19 cases will receive standard of care \\[oxygen via masks or ventilators\\]', 'interventionNames': ['Other: standard care']}], 'interventions': [{'name': 'Ivermectin nasal', 'type': 'DRUG', 'otherNames': ['ivermectin'], 'description': 'Ivermectin nasal spray one ml in each nostril two times daily', 'armGroupLabels': ['Ivermectin nasal spray']}, {'name': 'Ivermectin oral', 'type': 'DRUG', 'otherNames': ['ivermectin'], 'description': 'Ivermectin oral (one tablet 6 mg three times daily)', 'armGroupLabels': ['Ivermectin oral']}, {'name': 'standard care', 'type': 'OTHER', 'description': 'oxygen via masks or ventilators', 'armGroupLabels': ['standard care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kamal Okasha, PhD', 'role': 'CONTACT', 'email': 'okasha70@yahoo.com', 'phone': '201140403709'}, {'name': 'Nahla El-Ashmawy, PhD', 'role': 'CONTACT', 'email': 'nahlaelashmawy@yahoo.com', 'phone': '201116721982'}], 'overallOfficials': [{'name': 'Kamal Okasha, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta Univesity faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President', 'investigatorFullName': 'Prof. Dr. Kamal Mohammed Okasha', 'investigatorAffiliation': 'Tanta University'}}}}