Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-31 @ 6:15 AM
Study NCT ID:
NCT05504057
Status:
RECRUITING
Last Update Posted:
2025-03-11
First Post:
2022-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antihistamines, Amantadine and Evolution of the SARS-CoV-2 Infection
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': 'D006633', 'term': 'Histamine Antagonists'}, {'id': 'D000547', 'term': 'Amantadine'}], 'ancestors': [{'id': 'D018494', 'term': 'Histamine Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140660}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-02-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2022-08-15', 'studyFirstSubmitQcDate': '2022-08-15', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Admissions.', 'timeFrame': 'from march 2020.', 'description': 'Rate of Hospitalization among COVID 19 infections'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'from march 2020', 'description': 'Survival among COVID1 hospitalized cases.'}, {'measure': 'Symptomatic infection', 'timeFrame': 'from march 2020', 'description': 'Patients suffering a symptomatic COVID19 infection within a determinate age group'}, {'measure': 'Postcovid syndrome', 'timeFrame': 'from april 2020', 'description': 'Patients developing postcovid syndrome after COVID19 infection'}, {'measure': 'Thrombosis', 'timeFrame': 'from april 2020', 'description': 'Patients developing thrombosis (with particular assessment of stroke, cardiac infarction, retinal vessels and pulmonary embolism)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antihistamines', 'amantadine', 'hospital admissions', 'survival'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '33465426', 'type': 'BACKGROUND', 'citation': 'Moran Blanco JI, Alvarenga Bonilla JA, Homma S, Suzuki K, Fremont-Smith P, Villar Gomez de Las Heras K. Antihistamines and azithromycin as a treatment for COVID-19 on primary health care - A retrospective observational study in elderly patients. Pulm Pharmacol Ther. 2021 Apr;67:101989. doi: 10.1016/j.pupt.2021.101989. Epub 2021 Jan 16.'}, {'pmid': '33604795', 'type': 'BACKGROUND', 'citation': 'Cortes-Borra A, Aranda-Abreu GE. Amantadine in the prevention of clinical symptoms caused by SARS-CoV-2. Pharmacol Rep. 2021 Jun;73(3):962-965. doi: 10.1007/s43440-021-00231-5. Epub 2021 Feb 18.'}, {'pmid': '39770791', 'type': 'RESULT', 'citation': 'Puigdellivol-Sanchez A, Juanes-Gonzalez M, Calderon-Valdiviezo A, Losa-Puig H, Valls-Foix R, Gonzalez-Salvador M, Lozano-Paz C, Vidal-Alaball J. COVID-19 in Relation to Chronic Antihistamine Prescription. Microorganisms. 2024 Dec 13;12(12):2589. doi: 10.3390/microorganisms12122589.'}, {'pmid': '39459868', 'type': 'RESULT', 'citation': 'Puigdellivol-Sanchez A, Juanes-Gonzalez M, Calderon-Valdiviezo A, Valls-Foix R, Gonzalez-Salvador M, Lozano-Paz C, Vidal-Alaball J. COVID-19 in Relation to Polypharmacy and Immunization (2020-2024). Viruses. 2024 Sep 27;16(10):1533. doi: 10.3390/v16101533.'}]}, 'descriptionModule': {'briefSummary': 'The rates of symptomatic COVID19 infection, hospital admission among COVID19 cases and survival would be quantified in patiens chronically treated with antihistamines or amantadine, with the aim of determining the role of antihistamines and amantadine in the evolution of COVID19.', 'detailedDescription': 'BACKGROUND: According to previous reports, all 84 eldery residents in nuersing homes in Yespes (Toledo, Spain), had a 100% of positive serology for COVID-19 in June 2020, but none died nor hospitalized after receiving early treatment with antihistamines. Other case reports have suggested a protective role of amantadine, since infected patients showed a very mild COVID19 infection.\n\nOBJECTIVES.Determine the role of antihistamines and amantadine in the evolution of COVID19.\n\nMETHODS. Describe the rate of hospitalization, ICU, survival, postcovid syndrome and thrombosis among COVID 19 cases having antihistamines and amantadine as chronic treatments.\n\nThe rates would be stratified by age groups and compared with the same age groups of the population assigned to the public free Access Terrassa Health Consortium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population assigned to the Public and free Access Terrassa Health Consortium', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Patients having chronic treatment with antihistamines or amantadine -\n\nExclusion Criteria: None\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05504057', 'briefTitle': 'Antihistamines, Amantadine and Evolution of the SARS-CoV-2 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari de Terrassa'}, 'officialTitle': 'Evaluation of Treatments With Antihistamines and Amantadine in the Evolution of the SARS-CoV-2 Infection', 'orgStudyIdInfo': {'id': '02-22-161-060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with chronic treatment with antihistamines or amantadine', 'description': 'The % of patients having antihistamines or amantadine as chronic treatment that suffered COVID would be compared to the population of the Terrassa Health Consortium (THC) of the same age groups.', 'interventionNames': ['Drug: Antihistamine', 'Drug: Amantadine']}, {'label': 'Other population of the THC', 'description': 'The % of patients of the Terrassa Health Consortium that suffered COVID19 infection of the same age groups.'}], 'interventions': [{'name': 'Antihistamine', 'type': 'DRUG', 'otherNames': ['Antihistamine as crhonic treatment and COVID19 infection.'], 'description': 'Observation of the rate of COVID19 infection, the rate of hospitalization, the rate of survival and postcovid syndrome and thrombosis among patients previously treated with antihistamines', 'armGroupLabels': ['Patients with chronic treatment with antihistamines or amantadine']}, {'name': 'Amantadine', 'type': 'DRUG', 'otherNames': ['Amantadine as chronic treatment and COVID19 infection.'], 'description': 'Observation of the rate of COVID19 infection, the rate of hospitalization, the rate of survival and the rate of postcovid syndrome and thrombosis among patients previously treated with amantadine', 'armGroupLabels': ['Patients with chronic treatment with antihistamines or amantadine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08227', 'city': 'Terrassa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Anna Puigdellívol-Sánchez, Ph.D.', 'role': 'CONTACT', 'email': 'apuigdellivol@cst.cat', 'phone': '34-93-5884555'}], 'facility': 'Hospital de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '08227', 'city': 'Terrassa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Anna Puigdellívol, PhD', 'role': 'CONTACT'}], 'facility': 'Hospital of Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'centralContacts': [{'name': 'Anna Puigdellivol, Ph.D', 'role': 'CONTACT', 'email': 'apuigdellivol@cst.cat', 'phone': '34-93-5884555'}], 'overallOfficials': [{'name': 'Anna Puigdellívol, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Terrassa Health Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Once the papers related to the study are published, a statement will be included offering data when contacting with the authors.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorci Sanitari de Terrassa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut Català de la Salut', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna Puigdellívol-Sánchez', 'investigatorAffiliation': 'Consorci Sanitari de Terrassa'}}}}