Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-01 @ 12:49 AM
Study NCT ID:
NCT04558203
Status:
COMPLETED
Last Update Posted:
2025-04-17
First Post:
2020-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'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': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10510}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2020-09-19', 'studyFirstSubmitQcDate': '2020-09-19', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Autoimmune Diseasee', 'timeFrame': '2016-2024', 'description': 'The number of new AID cases per 100,000 population before and after COVID-19, analyzed using retrospective and prospective data.'}, {'measure': 'Disease severity', 'timeFrame': 'one week', 'description': 'Severity as mild, moderate, severe according to type of AIDs'}, {'measure': 'recurrence of AIDs', 'timeFrame': 'one year', 'description': 'number of recurrence of the disease within the follow up period'}, {'measure': 'response to therapy in the acute phase', 'timeFrame': 'within 4 weeks', 'description': 'good response, weak response that need escalation of the dose of corticosteroids, no response'}], 'secondaryOutcomes': [{'measure': 'recurrence as another auto-immune disease', 'timeFrame': 'Up to 4 years', 'description': 'recurrence of different auto-immune disease'}, {'measure': 'change in inflammatory markers', 'timeFrame': 'Two-months to Twelve months', 'description': 'behavior of laboratory data of C-reactive protein, sedimentation rate, ferritine'}, {'measure': 'incidence of other complications', 'timeFrame': 'Two-months to Twelve months', 'description': 'incidence of other complications'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '32535093', 'type': 'BACKGROUND', 'citation': 'Ehrenfeld M, Tincani A, Andreoli L, Cattalini M, Greenbaum A, Kanduc D, Alijotas-Reig J, Zinserling V, Semenova N, Amital H, Shoenfeld Y. Covid-19 and autoimmunity. Autoimmun Rev. 2020 Aug;19(8):102597. doi: 10.1016/j.autrev.2020.102597. Epub 2020 Jun 11. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The study explore the relationship between COVID-19 and the induction of autoimmune diseases.\n\nThis study comprises both retrospective and prospective components. The retrospective arm (2016-2019) was conducted to establish baseline incidence rates of autoimmune diseases (AIDs) prior to the COVID-19 pandemic. The prospective arm (2020-2024) involves the identification and longitudinal follow-up of newly diagnosed AID cases to evaluate disease progression, therapeutic response, and recurrence. Based on these data, the study will yield four distinct analyses:\n\n1. trends in AID incidence before and after the COVID-19 pandemic,\n2. the demographic and clinical profile of AID patients in the post-COVID-19 era,\n3. the association between COVID-19 vaccine status and the development of AIDs, and\n4. the clinical course, response to therapy, and long-term outcomes of AIDs in post-COVID patients compared to pre-pandemic cases.', 'detailedDescription': 'It has been suggested that the shared pathogenetic mechanisms and clinical-radiological aspects between the hyper-inflammatory diseases and Covid-19 may suggest that SARS-CoV-2 could act as a triggering factor for the development of a rapid autoimmune and/or autoinflammatory dysregulation, leading to the severe interstitial pneumonia, in genetic predisposed individuals.\n\nThe study is designed to investigate four primary objectives:\n\n1. the incidence and trends of autoimmune diseases (AIDs) before and after the COVID-19 pandemic,\n2. the association between COVID-19 vaccine status and the development of AIDs,\n3. the clinical progression, treatment response, and recurrence of AIDs in post-COVID patients, and\n4. the demographic and clinical profile, contributing factors, and spectrum of AID types identified during the post-pandemic period.\n\nRetrospective data from 2016 to 2019 will be analyzed to establish baseline incidence rates, while prospective data from 2020 to 2024 will focus on new cases, vaccine exposure, clinical course, and patient characteristics.\n\nThe investigators hypothesize that:\n\n1. the incidence of AIDs has increased in the post-COVID-19 era compared to the pre-pandemic period,\n2. there is a positive association between COVID-19 vaccination and the onset of AIDs,\n3. the clinical course and therapeutic response of AIDs in post-COVID patients differ from historical cases, and\n4. unique demographic and clinical patterns characterize AID cases arising during the post-COVID period.\n\nAccordingly, the study will yield four distinct analyses, each to be reported in a separate manuscript corresponding to the above objectives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the study population are all patients came to the center with or without symptoms and signs suspected to be AID during the study period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all gender\n* all age\n\nExclusion Criteria:\n\n* Those who refused to participate'}, 'identificationModule': {'nctId': 'NCT04558203', 'briefTitle': 'The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice', 'organization': {'class': 'OTHER', 'fullName': 'ClinAmygate'}, 'officialTitle': 'The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice', 'orgStudyIdInfo': {'id': 'PR0014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Autoimmune suspected cases', 'description': 'Cases suspected to have autoimmune diseases'}, {'label': 'non - autoimmune suspected cases', 'description': 'non - autoimmune suspected cases'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11433', 'city': 'Maadi', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Asalam', 'geoPoint': {'lat': 29.95958, 'lon': 31.25924}}], 'overallOfficials': [{'name': 'Emad R Issak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asalam Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ClinAmygate', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}