Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT04784403
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2020-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SCREENING AND SEROEPIDEMIOLOGY OF SARS-CoV-2 INFECTION AT THE UNIVERSITY OF BARCELONA: A CROSS-SECTIONAL STUDY
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': 'D012698', 'term': 'Serologic Tests'}], 'ancestors': [{'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3356}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2020-12-21', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Estimation of associated factors ith the main variable (age, sex, university group and variables of exposure and preventive measures)', 'timeFrame': 'one day'}], 'primaryOutcomes': [{'measure': 'Number of people with a positive SARS-CoV-2 PCR.', 'timeFrame': 'one day'}, {'measure': 'Incidence of people with a positive SARS-CoV-2 PCR.', 'timeFrame': 'one day'}, {'measure': 'Number of people with a positive total immunoglobulin titer and positive IgG for SARS-CoV-2.', 'timeFrame': 'one day'}, {'measure': 'Prevalence of people with a positive total immunoglobulin titer and positive IgG for SARS-CoV-2.', 'timeFrame': 'one day'}], 'secondaryOutcomes': [{'measure': 'Number of people with a positive SARS-CoV-2 Ig total titer and a negative IgG.', 'timeFrame': 'one day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-COV-2', 'prevalence', 'Associated factors', 'University of Barcelona'], 'conditions': ['SARS-CoV-2 Infection']}, 'referencesModule': {'references': [{'pmid': '32645347', 'type': 'BACKGROUND', 'citation': 'Pollan M, Perez-Gomez B, Pastor-Barriuso R, Oteo J, Hernan MA, Perez-Olmeda M, Sanmartin JL, Fernandez-Garcia A, Cruz I, Fernandez de Larrea N, Molina M, Rodriguez-Cabrera F, Martin M, Merino-Amador P, Leon Paniagua J, Munoz-Montalvo JF, Blanco F, Yotti R; ENE-COVID Study Group. Prevalence of SARS-CoV-2 in Spain (ENE-COVID): a nationwide, population-based seroepidemiological study. Lancet. 2020 Aug 22;396(10250):535-544. doi: 10.1016/S0140-6736(20)31483-5. Epub 2020 Jul 6.'}, {'type': 'BACKGROUND', 'citation': '5. Albert Bosch. SARS-CoV-2: ¿No solo un virus? Ciclo de webinars. Patógenos Online. Grupo Especializado en Biología de Microrganismos Patógenos (GEBMP). Sociedad Española de Microbiología, 30 de junio de 2020.'}], 'seeAlsoLinks': [{'url': 'https://www.mscbs.gob.es/profesionales/saludPublica/ccayes/alertasActual/nCov-China/documentos/ITCoronavirus.pdf', 'label': 'Scientific-technical information report on coronavirus disease, COVID-19 in Spain. Center for Coordination of Health Alerts and Emergencies. July 3, 2020.'}, {'url': 'https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200817-weekly-epi-update-1.pdf?sfvrsn=b6d49a76_4', 'label': 'Situation report Nro. 168 about coronavirus disease (COVID-19). World Health Organization. 16 July 2020.'}]}, 'descriptionModule': {'briefSummary': 'BACKGROUND: On January 7, 2020, the Chinese authorities identified as the agent responsible for the cases of atypical pneumonia of unknown etiology a new type of virus of the Coronaviridae family that has subsequently been named SARS-CoV-2, whose genetic sequence was shared by Chinese authorities on January 12 (taxonomy ID: 2697049). On January 30, 2020, the director general of the World Health Organization (WHO), following the advice of the Emergency Committee convened in accordance with the International Health Regulations (2005), declared that the COVID-19 outbreak started in Wuhan, China in December 2019, being a public health emergency of international concern. On March 11, the WHO declared the global SARS-CoV-2 pandemic.\n\nSo far, in the absence of effective vaccines or antiviral drugs, efforts have focused on identifying cases and their contacts. Both the cases and their contacts are isolated for about 14 days with the intention of minimizing the spread of this infection and avoiding an increase in the number of affected.\n\nAt the time of writing this new version of the protocol, we are immersed in the second wave of the COVID-19 pandemic. The projections of the natural history of the disease and the estimates of possible infections by SARS-CoV-2, carried out at the end of the first wave, made it possible to determine the feasibility of this second wave with the onset of cold from the autumn.\n\nGiven this scenario, the University of Barcelona, together with the Gerencia Territorial del Área Metropolitana Sud, has planned to carry out, a study of seroprevalence and screnning of SARS-CoV-2 in the population of Universidad de Barcelona users.\n\nThe results of this study will help to make preventive decisions in the face of SARS-CoV-2 infection at the UB, in relation to its teaching and administrative activities. In addition, this cross-sectional study can serve as the base study for a future follow-up study.\n\nHYPOTHESIS: The incidence of SARS-CoV-2 infection in the group of students and workers at the University of Barcelona is similar to the incidence in the general population.\n\nMAIN OBJECTIVE:\n\n* Estimate the incidence of SARS-CoV-2 infection in the UB community.\n* Estimate the SARS-CoV-2 seroprevalence infection in the UB community.', 'detailedDescription': 'BACKGROUND: On January 7, 2020, the Chinese authorities identified as the agent responsible for the cases of atypical pneumonia of unknown etiology a new type of virus of the Coronaviridae family that has subsequently been named SARS-CoV-2, whose genetic sequence was shared by Chinese authorities on January 12 (taxonomy ID: 2697049).\n\nOn January 30, 2020, the director general of the World Health Organization (WHO), following the advice of the Emergency Committee convened in accordance with the International Health Regulations (2005), declared that the COVID-19 outbreak started in Wuhan, China in December 2019, being a public health emergency of international concern. On March 11, the WHO declared the global SARS-CoV-2 pandemic.\n\nSo far, in the absence of effective vaccines or antiviral drugs, efforts have focused on identifying cases and their contacts. Both the cases and their contacts are isolated for about 14 days with the intention of minimizing the spread of this infection and avoiding an increase in the number of affected.\n\nAt the level of microbiological clinical practice, the diagnosis of SARS-CoV-2 infection can be made by:\n\n1. Detection of the presence of the target nucleic acid sequences in the RNA of SARS-CoV-2 (RdRP gene of SARSCoV-2 and gene N and Orf1ab present in SARS and SARSCoV-2, gene E of SARS) in the Patient specimen by reverse transcriptase polymerase chain reaction (RT-PCR).\n2. Detection of antibodies: total immunoglobulins and IgG.\n\nAt the time of writing this new version of the protocol, the country is immersed in the second wave of the COVID-19 pandemic. The projections of the natural history of the disease and the estimates of possible infections by SARS-CoV-2, carried out at the end of the first wave, made it possible to determine the feasibility of this second wave with the onset of cold from the autumn. Some of the factors that supported this hypothesis are:\n\n1. At the end of the first wave, herd immunity against the virus was not reached. The results of the ENE-COVID study, published in the Lancet magazine in July this year, indicated that in our environment only 6% have achieved immunity.\n2. Many respiratory viruses have a seasonal behavior and their circulation increases in the autumn and winter months. This is why a similar behavior was assumed in this new SARS-CoV-2 virus, experiencing greater transmissibility with the drop in temperature and increase in humidity, typical of winter periods.\n3. Observing the evolution of the 1918 pandemic flu, the first wave was in 1918, but this was followed by a second and third wave, in 1919 and 1920 respectively. However, the second wave presented the peculiarity of being triggered in other areas where the first wave had not been so intense.\n\nGiven this scenario, the University of Barcelona, together with the Gerencia Territorial del Área Metropolitana Sud, has planned to carry out, a study of seroprevalence and screnning of SARS-CoV-2 in the population of UB users. The results of this study will help to make preventive decisions in the face of SARS-CoV-2 infection at the UB, in relation to its teaching and administrative activities. In addition, this cross-sectional study can serve as the base study for a future follow-up study.\n\nHYPOTHESIS: The incidence of SARS-CoV-2 infection in the group of students and workers at the University of Barcelona is similar to the incidence in the general population.\n\nThe seroprevalence of SARS-CoV-2 infection in the group of students and workers at the University of Barcelona is similar to the seroprevalence of the general population.\n\nMAIN OBJECTIVE\n\n* Estimate the incidence of SARS-CoV-2 infection in the UB community.\n* Estimate the SARS-CoV-2 seroprevalence infection in the UB community.\n\nSECONDARY OBJECTIVES\n\nClinical objectives:\n\n* Estimate the factors associated with the incidence in the UB community.\n* Estimate the factors associated with seroprevalence in the UB community\n\nSTUDY DESIGN Cross-sectional study with epidemiological information to determine the incidence and prevalence of SARS-CoV-2 infection in the UB population, by PCR and serology tests to detect antibodies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The target population of this study is made up of students and workers at the University of Barcelona:\n\n* Students from the different centers and type of studies (undergraduate / graduate).\n* Administrative and service personnel.\n* Teaching and Research Staff.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult population (18 years or more), of both sexes.\n* Person linked (with identification card) to the University of Barcelona.\n* Acceptance to participate in the study.\n\nExclusion Criteria:\n\nThere are no exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT04784403', 'acronym': 'UB-GTMS-COVID', 'briefTitle': 'SCREENING AND SEROEPIDEMIOLOGY OF SARS-CoV-2 INFECTION AT THE UNIVERSITY OF BARCELONA: A CROSS-SECTIONAL STUDY', 'organization': {'class': 'OTHER', 'fullName': 'University of Barcelona'}, 'officialTitle': 'SCREENING AND SEROEPIDEMIOLOGY OF SARS-CoV-2 INFECTION AT THE UNIVERSITY OF BARCELONA: A CROSS-SECTIONAL STUDY', 'orgStudyIdInfo': {'id': 'UB-EPI-2020-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Students and workers at the University of Barcelona', 'description': 'The study population will be randomly selected from the different groups of the University:\n\n* Students from the different centers and type of studies (undergraduate / graduate).\n* Administrative and service personnel.\n* Teaching and Research Staff.', 'interventionNames': ['Diagnostic Test: SARS-CoV-2 PCR and serology tests']}], 'interventions': [{'name': 'SARS-CoV-2 PCR and serology tests', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['epidemiological survey'], 'description': 'Once the informed consent has been signed, the selected subjects must complete an epidemiological survey and go to a UB sample collection center to perform a PCR and serology test for SARS-CoV-2.', 'armGroupLabels': ['Students and workers at the University of Barcelona']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Francisco Ciruela Alférez', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'overallOfficials': [{'name': 'Sebastià Videla Cés, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario de Bellvitge'}, {'name': 'Esteve Fernández Muñoz, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Barcelona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Francisco Ciruela Alférez', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gerencia Territorial del Área Metropolitana Sur - Instituto Catalán de la Salud', 'class': 'UNKNOWN'}, {'name': 'Hospital Universitario de Bellvitge', 'class': 'UNKNOWN'}, {'name': 'Fundació IDIBELL', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Sponsor's representative", 'investigatorFullName': 'Dr. Francisco Ciruela Alférez', 'investigatorAffiliation': 'University of Barcelona'}}}}