Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-27 @ 8:23 AM
Study NCT ID:
NCT04425850
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2020-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hymcarvallo@hotmail.com', 'phone': '54144800949', 'title': 'Dr. Héctor Carvallo', 'organization': 'Eurnekian Public Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'Medical examination Chart of adverse events filled in by subjects', 'eventGroups': [{'id': 'EG000', 'title': 'IVER+', 'description': 'Standard prophylactic measures and PPEs + topical treatment with iota carrageenan (nasal and buccal) and ivermectin (buccal).', 'otherNumAtRisk': 131, 'deathsNumAtRisk': 131, 'otherNumAffected': 0, 'seriousNumAtRisk': 131, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'IVER-', 'description': 'Standard prophylactic measures and PPEs only', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 11, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Contagion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IVER+', 'description': 'Standard prophylactic measures and PPEs + topical treatment with iota carrageenan (nasal and buccal) and ivermectin (buccal)'}, {'id': 'OG001', 'title': 'IVER-', 'description': 'Standard prophylactic measures and PPEs only'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Chi-squared test on the percentage of subjects who contracted COVID-19 in each arm', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Number of participants testing positive for COVID-19 after inclusion in each arm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Hispanic'}, {'type': 'SECONDARY', 'title': 'Adverse Events Other Than Those Resulting From Contagion or Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IVER+', 'description': 'Standard prophylactic measures and PPE + Treatment with iota carragenan (nasal and buccal) and ivermectin (buccal only)'}, {'id': 'OG001', 'title': 'IVER-', 'description': 'Standard prophylactic measures and PPE only'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Adverse events reported by subjects of each arm are recorded other than those resulting from contagion or disease progression', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Hispanic'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IVER+', 'description': 'Standard prophylactic measures and PPEs + iota carrageenan (nasal and buccal) and ivermectin (buccal)'}, {'id': 'FG001', 'title': 'IVER-', 'description': 'Standard prophylactic measures and PPE only'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Standard prophylactic measures and PPE + iota carrageenan (nasal and buccal) and ivermectin (buccal)', 'groupId': 'FG000', 'numSubjects': '131'}, {'comment': 'Standard prophylactic measures and PPE only', 'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Health personnel', 'preAssignmentDetails': 'Once consent was signed, compliance with all the eligibility criteria verified, and inclusion of the subject decided, the investigator assigns corresponding treatment according to the randomization carried out.\n\nIt includes volunteers for both cohorts, provided they have test negative for COVID 19 in swabs obtained immediately before inclusion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IVER+', 'description': 'Adults, both genders, no age limit. They will be provided with topical medication, to be used 5 times a day. PPEs used as suggested by OMS.\n\niota carrageenan: topical use on nasal mucosae\n\nIvermectin: Topical use on oral mucosae'}, {'id': 'BG001', 'title': 'IVER-', 'description': 'Same as IVER+ They will follow PPEs suggestions, only.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '60'}, {'value': '39', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '50'}, {'value': '40', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-29', 'size': 178357, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-08T19:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2020-06-08', 'resultsFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2020-06-08', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-15', 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Infected Subjects', 'timeFrame': '28 days', 'description': 'Number of participants testing positive for COVID-19 after inclusion in each arm'}], 'secondaryOutcomes': [{'measure': 'Adverse Events Other Than Those Resulting From Contagion or Disease Progression', 'timeFrame': '28 days', 'description': 'Adverse events reported by subjects of each arm are recorded other than those resulting from contagion or disease progression'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IVERMECTIN CARRAGEENAN COVID 19'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '19576248', 'type': 'BACKGROUND', 'citation': 'Harden EA, Falshaw R, Carnachan SM, Kern ER, Prichard MN. Virucidal activity of polysaccharide extracts from four algal species against herpes simplex virus. Antiviral Res. 2009 Sep;83(3):282-9. doi: 10.1016/j.antiviral.2009.06.007. Epub 2009 Jul 1.'}, {'pmid': '15498610', 'type': 'BACKGROUND', 'citation': 'Carlucci MJ, Scolaro LA, Noseda MD, Cerezo AS, Damonte EB. Protective effect of a natural carrageenan on genital herpes simplex virus infection in mice. Antiviral Res. 2004 Nov;64(2):137-41. doi: 10.1016/j.antiviral.2004.07.001.'}, {'pmid': '27514873', 'type': 'BACKGROUND', 'citation': 'Ashraf S, Prichard R. Ivermectin exhibits potent anti-mitotic activity. Vet Parasitol. 2016 Aug 15;226:1-4. doi: 10.1016/j.vetpar.2016.06.015. Epub 2016 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'Estimation of the prevalence and contagiousness of undocumented novel coronavirus infections is critical for understanding the overall prevalence and pandemic potential of this disease.\n\nIt is estimated that 86% of all infections were undocumented \\[95% credible interval (CI): 82-90%\\] before the 23 January 2020 travel restrictions. The transmission rate of undocumented infections per person was 55% the transmission rate of documented infections (95% CI: 46-62%), yet, because of their greater numbers, undocumented infections were the source of 79% of the documented cases.\n\nIvermectin + Carrageenan, taking advantage of their virucidal effects, are aimed at reducing the contagion.', 'detailedDescription': "CONTAGION COURSE Estimation of the prevalence and contagiousness of undocumented novel coronavirus infections is critical for understanding the overall prevalence and pandemic potential of this disease.\n\nObservations of reported infection within China, in conjunction with mobility data, a networked dynamic metapopulation model, and Bayesian inference, to infer critical epidemiological characteristics associated with SARS-CoV-2, including the fraction of undocumented infections and their contagiousness, have been attempted. The rapid geographic spread of SARS-CoV-2 indicate that containment of this virus will be particularly challenging.\n\nDISSEMINATION BY DROPLETS For COVID-19, the salivary gland could be an important source of the virus in saliva and would generate infectious saliva on a sustained basis.\n\nACE2 expression in the minor salivary glands was higher than in the lungs, suggesting that the salivary glands is a potential target for COVID-19.\n\nThe positive rate of COVID-19 in the patients' saliva can reach 91.7%, and the saliva samples can also culture the live virus.\n\nIn addition to mobility restrictions of people, the World Health Organization and the Governments have prescribed maintaining an inter-personal distance of 1.5 or 2 m (about 6 feet) from each other in order to minimize the risk of contagion through the droplets that we usually disseminate around us from nose and mouth. However, recently published studies support the hypothesis of virus transmission over a distance of 2 m from an infected person. Researchers have proved the higher aerosol and surface stability of SARS-COV-2 as compared with SARS-COV-1 (with the virus remaining viable and infectious in aerosol for hours) and that airborne transmission of SARS-CoV can occur besides close-distance contacts. Indeed, there is reasonable evidence about the possibility of SARS-COV-2 airborne transmission due to its persistence into aerosol droplets in a viable and infectious form. Based on the available knowledge and epidemiological observations, it is plausible that small particles containing the virus may diffuse in indoor environments covering distances up to 10 m from the emission sources, thus representing a kind of aerosol transmission. On-field studies carried out inside Wuhan Hospitals showed the presence of SARS-COV-2 RNA in air samples collected in the hospitals and also in the surroundings, leading to the conclusion that the airborne route has to be considered an important pathway for viral diffusion. Similar findings are reported in analyses concerning air samples collected at the Nebraska University Hospital. On March 16th, we have released a Position Paper emphasizing the airborne route as a possible additional factor for interpreting the anomalous COVID-19 outbreaks in northern Italy, ranked as one of the most polluted areas in Europe and characterized by high particulate matter (PM) concentrations. The available information on the SARS-COV-2 spreading supports the hypothesis of airborne diffusion of infected droplets from person to person at a distance greater than two meters (6 feet). The inter-personal distance of 2 m can be reasonably considered as an effective protection only if everybody wears face masks in daily life activities.\n\nIVERMECTIN CONCENTRATION IN SALIVARY GLANDS The concentration of ivermectin was tested in different tissues, in different studies, both in animals and human beings. The concentration in salivary glands proved to be adequately acceptable.\n\nCARRAGEENAN VIRUCIDAL EFFECTS Iota Carrageenan is widely used in gastronomic, cosmetic and pharmacologic industry.\n\nRecently, its intrinsic virucidal effectas were proved over a variety of virus (herpes simplex, Japanese Encephalitis, Rhinovirus, etc.).\n\nIts mechanism of action is preventing virus adsorption to host cells. By applying both drugs topically, 5 times per day, in nasal and oral mucosae, we try to reduce contagion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers testing negative for COVID-19 just before inclusion.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Not younger than 18 years of either sex\n2. Health personnel from the Dr. Alberto Eurnekian Interzonal University Hospital\n3. No COVID-19 related symptoms\n4. Able to understand and give written informed consent\n\nExclusion criteria\n\n1. Known hypersensitivity or allergy to any component of the product under evaluation\n2. Age under 18 years\n3. Use of immunosuppressants (including systemic corticosteroids) in the past 30 days.\n4. Pregnant or nursing.\n5. Patients with other acute infectious diseases.\n6. Patients with autoimmune disease and / or decompensated chronic diseases.\n7. Unable to fulfill the administrative tasks proposed by the study.\n8. Infection with SARSCoV-2 confirmed by PCR or rapid test authorized by ANMAT.'}, 'identificationModule': {'nctId': 'NCT04425850', 'acronym': 'IVERCAR', 'briefTitle': 'USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19', 'organization': {'class': 'OTHER', 'fullName': 'Eurnekian Public Hospital'}, 'officialTitle': 'USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid Among Healthy People and Health Personnel', 'orgStudyIdInfo': {'id': 'IVERCAR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IVER+', 'description': 'Adults, both genders, no age limit. They will be provided with topical medication, to be used 5 times a day. They will follow standard prophylactic measures and use PPE as suggested by OMS.', 'interventionNames': ['Combination Product: Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)']}, {'label': 'IVER-', 'description': 'Adults, both genders, no age limit They will follow standard prophylactic measures and use PPE suggestions, only.'}], 'interventions': [{'name': 'Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Nasitral (iota carrageenan nasal spray), Ivercass (ivermectin oral drops)'], 'description': 'Topical application in the nose and oral cavity', 'armGroupLabels': ['IVER+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1802', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Eurnekian', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eurnekian Public Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hector E Carvallo', 'investigatorAffiliation': 'Eurnekian Public Hospital'}}}}