Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-02-17 @ 11:14 PM
Study NCT ID:
NCT04530461
Status:
UNKNOWN
Last Update Posted:
2020-09-22
First Post:
2020-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D012859', 'term': "Sjogren's Syndrome"}, {'id': 'D012507', 'term': 'Sarcoidosis'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D001528', 'term': 'Behcet Syndrome'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D025241', 'term': 'Spondylarthritis'}], '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'}, {'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': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone 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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-19', 'studyFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serological Profile', 'timeFrame': 'Inclusion', 'description': 'Number of patients with positive serological test of SARS Cov2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV Infection', 'Systemic Disease', 'Systemic Lupus Erythematosus', "Sjogren's Syndrome", 'Sarcoidosis', 'Inflammatory Myopathy', 'Behçet Disease', 'Rheumatoid Arthritis', 'Spondyloarthritis']}, 'descriptionModule': {'briefSummary': "An observational study aiming to assess the serological profile of SARS-Cov2 patients with systemic diseases such as systemic lupus erythematosus, Sjogren syndrome, sarcoidosis, inflammatory myopathies, Behçet's disease, Rheumatoid arthritis and Spondyloarthritis", 'detailedDescription': 'The study is a prospective, observational, multicenter clinical trial to be conducted in the internal medicine, rheumatology and virology departments of Military Hospital of Tunis. After obtaining informed consent from the patient, the investigator will perform an inclusion visit made of a patient interview and performing blood sample to search for IgG and anti-SARS IgM CoV2.\n\nPatients with IgM-like antibodies will have an RT-PCR test for active infection. If the study participants will be diagnosed with COVID-19 positive during the study period, the attending physician is entitled to decide on their management based on the severity of the clinical status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with one of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age over 18 years old\n* One of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.\n* Informed consent obtained and signed\n\nExclusion Criteria:\n\n* Refusal to repeat blood sampling if the first one was badly performed\n* Informed consent not obained"}, 'identificationModule': {'nctId': 'NCT04530461', 'briefTitle': 'Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Military Hospital of Tunis'}, 'officialTitle': 'Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases', 'orgStudyIdInfo': {'id': 'UR17DN02-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Serological test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Positive serological test of SARS Cov2'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tunis', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Faida Ajili, MD', 'role': 'CONTACT', 'email': 'faida1977@yahoo.fr', 'phone': '+21698631188'}, {'name': 'Faida Ajili, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sameh Sayahi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rim Dhahri, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Military Hospital of Tunis', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'centralContacts': [{'name': 'Faida Ajili, MD', 'role': 'CONTACT', 'email': 'faida1977@yahoo.fr', 'phone': '+21698631188'}], 'overallOfficials': [{'name': 'Faida Ajili, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Military Hospital of Tunis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'faida agili', 'class': 'OTHER'}, 'collaborators': [{'name': 'UR17DN02 : Autoimmune Diseases Research Unit', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Autoimmune Diseases Research Unit (UR17DN02) and Professor in internal medicine departement. Sponsor and Principal Investigator', 'investigatorFullName': 'faida agili', 'investigatorAffiliation': 'Military Hospital of Tunis'}}}}