Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 8:05 AM
Study NCT ID:
NCT04490850
Status:
COMPLETED
Last Update Posted:
2022-02-15
First Post:
2020-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Seroprevalence Study in French Guiana
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3541}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-07-28', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of the COVID-19 immunity of the population', 'timeFrame': '1 year', 'description': 'The COVID-19 immunity of the population will be assessed by evaluating the anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the level of asymptomatic and pauci-symptomatic infections', 'timeFrame': '1 year', 'description': 'The proportion of asymptomatic and pauci-symptomatic infections will be measured in the population'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'COVID-19', 'Serology', 'French Guiana'], 'conditions': ['Coronavirus Infection', 'Severe Acute Respiratory Syndrome', 'SARS-CoV Infection', 'Covid19']}, 'descriptionModule': {'briefSummary': 'Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.', 'detailedDescription': 'Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.\n\nThis study is a interventional study that present minimal risks and constraints.\n\nThe results of the study will allow estimation of COVID-19 virus infection, severity and attack rates, as well as inform public health responses and policy decisions in the French Guiana territory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person going to a prevention and care center or medical biology analysis laboratory as part of the care, regardless age, regardless of an acute or previous infection with COVID-19;\n* State of health compatible with a blood sample as defined in the protocol\n\nExclusion Criteria:\n\n* Inability to consent\n* Person under guardianship or curatorship\n* Known pathology or a health problem contraindicated with the collect of blood sample.'}, 'identificationModule': {'nctId': 'NCT04490850', 'acronym': 'EPI-COVID-POP', 'briefTitle': 'COVID-19 Seroprevalence Study in French Guiana', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut Pasteur'}, 'officialTitle': 'COVID-19 Seroprevalence Study in French Guiana', 'orgStudyIdInfo': {'id': '2020-048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants', 'description': 'Blood sample', 'interventionNames': ['Procedure: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'PROCEDURE', 'description': 'Blood sample', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cayenne', 'country': 'French Guiana', 'facility': 'Centre Hospitalier Andrée Rosemon', 'geoPoint': {'lat': 4.9381, 'lon': -52.33455}}, {'city': 'Cayenne', 'country': 'French Guiana', 'facility': 'Laboratoire de biologie méicale, Institut Pasteur de la Guyane', 'geoPoint': {'lat': 4.9381, 'lon': -52.33455}}, {'city': 'Cayenne', 'country': 'French Guiana', 'facility': 'Laboratoires Eurofins Guyane', 'geoPoint': {'lat': 4.9381, 'lon': -52.33455}}, {'city': 'Kourou', 'country': 'French Guiana', 'facility': 'Laboratoire de biologie médicale de Kourou', 'geoPoint': {'lat': 5.16281, 'lon': -52.64265}}, {'city': 'Saint-Laurent-du-Maroni', 'country': 'French Guiana', 'facility': 'Laboratoire de biologie médicale du Centre hospitalier de Saint-Laurent du Maroni', 'geoPoint': {'lat': 5.50153, 'lon': -54.02916}}], 'overallOfficials': [{'name': 'Claude Flamand, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Pasteur de la Guyane, Head of Epidemiology Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Pasteur', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Institut Pasteur de la Guyane', 'class': 'UNKNOWN'}, {'name': 'Laboratoire de biologie médicale, Institut Pasteur de la Guyane', 'class': 'UNKNOWN'}, {'name': 'Laboratoire de biologie médicale de Kourou, French Guiana', 'class': 'UNKNOWN'}, {'name': 'Laboratoire de biologie médicale du Centre hospitalier de Saint-Laurent du Maroni, French Guiana', 'class': 'UNKNOWN'}, {'name': 'Eurofins', 'class': 'INDUSTRY'}, {'name': 'Centres Délocalisés de Prévention et de Soins, Centre Hospitalier Andrée Rosemon de Cayenne, Frech Guiana', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}