Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT04355702
Status:
COMPLETED
Last Update Posted:
2021-03-01
First Post:
2020-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Covid-19 in Lupus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-26', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence and severity of Covid-19 infection in patients with SLE', 'timeFrame': '1 day', 'description': 'prevalence and severity of Covid-19 infection in patients with SLE'}], 'secondaryOutcomes': [{'measure': 'prevalence and severity of Covid-19 infection in patients treated by hydroxychloroquine', 'timeFrame': '1 day', 'description': 'prevalence and severity of Covid-19 infection in patients treated by hydroxychloroquine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic lupus erythematosus', 'Hydroxychloroquine'], 'conditions': ['Systemic Lupus Erythematosus', 'Covid-19']}, 'descriptionModule': {'briefSummary': 'The Covid-19 pandemic is a major public health issue. Potential treatments are essential to control the infection. Hydroxychlorquine is currently tested in several clinical trials to evaluate its efficiency.The objective of this study was to evaluate the symptoms related to COVID-19 occuring in patients with systemic lupus erythematosus (SLE)', 'detailedDescription': "Introduction:The Covid-19 pandemic has had a major impact on many countries on the sanitary and economic level. Finding an efficient cure is paramount in order to reduce its severity and mortality. Several medications are currently under investigation. Among them, hydroxychloroquine can prevent viral replication at several sites and has been shown efficient in vitro. Several clinical trials are in progress to evaluate its efficiency in vivo. However, no study so far has evaluated the covid-19 infection in patients with SLE.\n\nObjectives and methods: The primary objective was to describe the prevalence and the severity of Covid-19 infection in patients wih systemic lupus erythematosus. The secondary objective was to compare these parameters in patients treated by hydroxychloroquine and those not treated by hydroxychloroquine. This observational study of a historical-prospective cohort focuses on all adult lupus patients seen during the last year in the departments of rheumatology and nephrology in CHU Montpellier. It will collect information concerning the patient's condition, treatments and main comorbidities (cardio-vascular, respiratory, hepatic and immune depression), as well as symptoms suggesting covid-19 infection, its confirmation and its course and severity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients with systemic lupus erythematosus followed by the departments of rheumatology and nephrology, seen during the last year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- adult patient with systemic lupus erythematosus seen during the last year in the departments of rheumatology or nephrology\n\nExclusion criteria:\n\n\\- patient not speaking french nor english'}, 'identificationModule': {'nctId': 'NCT04355702', 'briefTitle': 'Covid-19 in Lupus Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Manifestations Related to Covid-19 in Patients With Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'RECHMPL20_0219'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lupus patients treated by hydroxychloroquine', 'description': 'Lupus patients treated by hydroxychloroquine'}, {'label': 'Lupus patients not treated by hydroxychloroquine', 'description': 'Lupus patients not treated by hydroxychloroquine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Christian JORGENSEN, Resident', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}