Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-27 @ 6:59 AM
Study NCT ID:
NCT05172167
Status:
UNKNOWN
Last Update Posted:
2022-03-02
First Post:
2021-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of SARS-CoV-2 Antibodies Levels in a Vaccinated Population of Valle de Aburra
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-24', 'studyFirstSubmitDate': '2021-12-23', 'studyFirstSubmitQcDate': '2021-12-23', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IgG and IgM antibodies blood test levels generated by the different COVID-19 vaccines in people throughout the time of the study.', 'timeFrame': 'Through study completion, an average of 2 months'}], 'secondaryOutcomes': [{'measure': 'Comparing immunoglobulins M and G levels in vaccinated patients against SARS-CoV-2 with RNA and non RNA vaccines.', 'timeFrame': 'Through study completion, an average of 2 months'}, {'measure': 'SARS-CoV-2 infections in vaccinated patients against COVID-19.', 'timeFrame': 'Through study completion, an average of 2 months'}, {'measure': 'Correlate through time immunoglobulins M and G levels in people vaccinated against COVID-19 and SARS-CoV-2 acute infected patients.', 'timeFrame': 'Through study completion, an average of 2 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laboratory biomarkers', 'Health condition', 'COVID-19', 'Antibodies level', 'Vaccinated people'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Recent research evidence shows that levels of antibodies acquierd post vacunation against SARS-Cov-2 decrease over time as well as the efficacy to control the infection, additionally in a multicenter study carried out in 2020 were evidenced differences in the time it took to decrease the antibodies according to the type of vaccine, defined as mRNA or other types of vaccine.\n\nIn this study , the variation of the SARS-Cov-2 antibody levels in patients from Valle de Aburrá will be correlated according to the COVID-19 vaccine received.', 'detailedDescription': 'After being informed about the study, all patients giving written informed consent will undergo a serial IgM -IgG COVID-19 antibodies blood test and SARS-Cov-2 PCR by nasopharingeal swab, that will be taken at the beginning of the study and mensually for two months.\n\nDuring the study will be done an active search for SARS-CoV-2 infections in the vaccinated people cohort, and if it is posible to characterize the variant of SARS-CoV-2 in participants previously vaccinated against this pathogen.\n\nThe main objective of this study is to describe the pattern of antibodies blood test based in the type of vaccine and correlated the pattern of antibodies SARS-Cov-2 levels in a population of Valle de Aburrá.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with a fully vaccination scheme for COVID-19 according to the Ministerio de Salud y Protección Social de Colombia and patients diagnosed with SARS-CoV-2 infection in the last 60 days, without matter vaccination status against SARS-CoV-2.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult over 18 years old\n* The vaccinated patients to be included must have received a complete vaccination scheme for COVID-19 according to the Ministerio de Salud y Protección Social de Colombia\n* SARS-CoV-2 infection in the last 2 months, verified by rtPCR test\n\nExclusion Criteria:\n\n* Immunocompromised patients\n* Immunosuppressive treatments, chemotherapy or antiretroviral therapy\n* Outpatient anticoagulant therapy\n* For vaccinated people (groups 1 and 2): if have had COVID-19 infection in the last 6 months'}, 'identificationModule': {'nctId': 'NCT05172167', 'briefTitle': 'Prospective Evaluation of SARS-CoV-2 Antibodies Levels in a Vaccinated Population of Valle de Aburra', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Antioquia'}, 'officialTitle': 'Prospective Evaluation of Antibodies Levels Variation Against SARS-CoV-2 in a Vaccinated Population of the Metropolitan Area of Valle de Aburra . Pilot Prospective Cohort.', 'orgStudyIdInfo': {'id': 'LIME-21-P-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early vaccinated against COVID-19', 'description': '80 subjects with less than 4 months after being fully vaccinated against COVID-19', 'interventionNames': ['Diagnostic Test: Levels of IgG and IgM SARS-CoV-2 antibodies blood test.', 'Diagnostic Test: RT-PCR SARS-CoV-2 nasopharyngeal swab']}, {'label': 'Late vaccinated against COVID-19', 'description': '80 subjects with more than 4 months after being fully vaccinated against COVID-19', 'interventionNames': ['Diagnostic Test: Levels of IgG and IgM SARS-CoV-2 antibodies blood test.', 'Diagnostic Test: RT-PCR SARS-CoV-2 nasopharyngeal swab']}, {'label': 'COVID-19 infection', 'description': '40 patients diagnostic of COVID-19', 'interventionNames': ['Diagnostic Test: Levels of IgG and IgM SARS-CoV-2 antibodies blood test.', 'Diagnostic Test: RT-PCR SARS-CoV-2 nasopharyngeal swab']}], 'interventions': [{'name': 'Levels of IgG and IgM SARS-CoV-2 antibodies blood test.', 'type': 'DIAGNOSTIC_TEST', 'description': '0,1,2 months', 'armGroupLabels': ['COVID-19 infection', 'Early vaccinated against COVID-19', 'Late vaccinated against COVID-19']}, {'name': 'RT-PCR SARS-CoV-2 nasopharyngeal swab', 'type': 'DIAGNOSTIC_TEST', 'description': '0,1,2 months', 'armGroupLabels': ['COVID-19 infection', 'Early vaccinated against COVID-19', 'Late vaccinated against COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050022', 'city': 'Medellín', 'state': 'Antioquia', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Andres F Zuluaga', 'role': 'CONTACT'}], 'facility': 'Laboratorio Integrado de Medicina Especializada', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'centralContacts': [{'name': 'Ivone Jimenez', 'role': 'CONTACT', 'email': 'ivone.jimenez@udea.edu.co', 'phone': '+57 (4) 2196022'}], 'overallOfficials': [{'name': 'Andres F Zuluaga, MD, MSc, MeH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Antioquia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Antioquia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laboratorio integrado de medicina especializada(LIME)', 'class': 'UNKNOWN'}, {'name': 'Proyecto de regalias BPIN 2020000100152', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full profesor, senior researcher and head of the Department of Pharmacology and Toxicology in Antioquia University', 'investigatorFullName': 'Andres Felipe Zuluaga Salazar', 'investigatorAffiliation': 'Universidad de Antioquia'}}}}