Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-29 @ 2:33 PM
Study NCT ID:
NCT04410432
Status:
UNKNOWN
Last Update Posted:
2021-01-19
First Post:
2020-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response and Risk of Serious Infection to SARS-Cov2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2020-05-29', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of circulating Th1 lymphocytes', 'timeFrame': 'Until the end of the study, about 12 months.', 'description': 'Flow cytometry measurement of the percentage of circulating Th1 lymphocytes'}], 'secondaryOutcomes': [{'measure': 'Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11', 'timeFrame': 'Until the end of the study, about 12 months.', 'description': 'Immunofluorimetric measurement of serum concentrations of IFN-γ, CXCL9, CXCL10, CXCL11'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS Cov2, Immune Response']}, 'descriptionModule': {'briefSummary': 'To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%.\n\nApart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized for SARS-Cov-2 infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person having given his or her non-opposition\n* Patient hospitalized with an SARS-Cov2 infection proven by virological sampling (nasopharyngeal or sputum PCR) less than 8 days old.\n\nExclusion Criteria:\n\n* Person subject to a legal protection measure (curatorship, guardianship)\n* Person subject to a safeguard measure of justice\n* Pregnant, parturient or breastfeeding woman\n* Major incapable or incapable of giving consent\n* Minor'}, 'identificationModule': {'nctId': 'NCT04410432', 'briefTitle': 'Immune Response and Risk of Serious Infection to SARS-Cov2', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Immune Response and Risk of Serious Infection to SARS-Cov2', 'orgStudyIdInfo': {'id': 'GHESQUIERE AOIc 2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient', 'description': 'Patient hospitalized with SARS-Cov2 infection proven by virological sampling.', 'interventionNames': ['Biological: Blood sample collection']}], 'interventions': [{'name': 'Blood sample collection', 'type': 'BIOLOGICAL', 'description': 'Additional blood volumes taken during a routine care blood test:\n\n* 1 dry tube 5 mL for isolation and freezing of serum\n* 1 x 5 mL EDTA tube to isolate and freeze plasma\n* 8 heparinized 6 mL tubes for flow cytometry study', 'armGroupLabels': ['Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thibault GHESQUIERE', 'role': 'CONTACT', 'email': 'thibault.ghesquiere@chu-dijon.fr', 'phone': '0380293857', 'phoneExt': '+33'}], 'facility': 'Chu Dijon Bourogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'Thibault GHESQUIERE', 'role': 'CONTACT', 'email': 'thibault.squiere@chu-dijon.fr', 'phone': '0380293857', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}