Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT04384705
Status:
UNKNOWN
Last Update Posted:
2022-08-30
First Post:
2020-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HDL Target of CoViD19 ? Analysis on the Caregivers of the Reunion University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 361}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2020-05-11', 'lastUpdatePostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of lipid profile during exposure to SARS-Cov-2', 'timeFrame': 'at the end of the study, maximum 1 year', 'description': 'lipid profile'}], 'secondaryOutcomes': [{'measure': 'HDL-cholesterol size', 'timeFrame': 'at the end of the study, maximum 1 year', 'description': 'HDL-cholesterol size'}, {'measure': 'circulating plasma cytokine levels', 'timeFrame': 'at the end of the study, maximum 1 year', 'description': 'circulating plasma cytokine levels'}, {'measure': 'ACE2 gene polymorphisms', 'timeFrame': 'at the end of the study, maximum 1 year', 'description': 'ACE2 gene polymorphisms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV Infection']}, 'descriptionModule': {'briefSummary': 'Since December 2019, the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic has spread around the world. The people most exposed to this virus remain the healthcare personnel who are on the front line in the fight against this pandemic. Due to the delayed nature of the pandemic in Reunion island and its insular geographical situation, the study of the voluntary medical personnel will allow the investigators to establish a longitudinal follow-up of the anomalies of the lipidic balance in relation to the exposure to the SARS-Cov virus. 2. During bacterial infections, the lipid profiles are profoundly modified with very significant reductions in plasma cholesterol levels, LDL-C but especially HDL-C whose concentrations are particularly low. Lipid profiles are altered during viral infections, for example, the severity of dengue is inversely correlated with total cholesterol and LDL-C but not with HDL-C levels, according to a recent meta-analysis. The hepatitis C virus circulates in serum linked to lipoproteins rich in triglycerides and HDL can facilitate its entry into cells via Scavenger receptor class B type 1 (SRB1). Likewise, it has been shown that apoA1 can bind to the dengue virus and increase its infectivity by promoting its entry into cells, also via SRB1. At the moment, nothing is known about the lipid profiles in subjects with SARS-CoV-2. The investigator hypothesize that a drop in plasma HDL-C levels and a change in their size during infection could justify future therapeutic approaches aimed at supplementing the subjects most at risk of pulmonary complications. In a model of Pseudomonas aeruginosa pneumonia in mice, investigators have shown that the injection of reconstituted HDL allowed to limit the pulmonary inflammation and the deleterious consequences of the infection. The investigator propose to study not only the lipid profiles in subjects who are infected with SARS-CoV-2 but also the polymorphisms of genes involved in the regulation of lipoprotein levels like that of Cholesterol Ester-Transfer Protein (CETP) depending on the developed forms, symptomatic or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Caregiver in Reunion island University Hospital Center who practice in a care service possibly exposed to the coronavirus', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caregiver in Reunion island University Hospital Center\n* Practicing in a care service possibly exposed to the coronavirus\n* Signed Consent\n\nExclusion Criteria:\n\n* Refusal to participate\n* Already infected by Covid19'}, 'identificationModule': {'nctId': 'NCT04384705', 'acronym': 'H-Cov-Run', 'briefTitle': 'HDL Target of CoViD19 ? Analysis on the Caregivers of the Reunion University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'HDL Target of CoViD19 ? Analysis on the Caregivers of the Reunion University Hospital', 'orgStudyIdInfo': {'id': '2020/CHU/08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'caregivers', 'description': 'caregivers', 'interventionNames': ['Other: research specific blood sample']}], 'interventions': [{'name': 'research specific blood sample', 'type': 'OTHER', 'description': '* one blood sample before the epidemic phase\n* one blood sample during epidemic phase\n* one blood sample after epidemic phase', 'armGroupLabels': ['caregivers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97400', 'city': 'Saint-Denis', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Réunion', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '97448', 'city': 'Saint-Pierre', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de la Réunion', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}