The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice
NCT ID: NCT04558203
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10510 participants
OBSERVATIONAL
2020-09-22
2025-03-05
Brief Summary
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This 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:
1. trends in AID incidence before and after the COVID-19 pandemic,
2. the demographic and clinical profile of AID patients in the post-COVID-19 era,
3. the association between COVID-19 vaccine status and the development of AIDs, and
4. the clinical course, response to therapy, and long-term outcomes of AIDs in post-COVID patients compared to pre-pandemic cases.
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Detailed Description
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The study is designed to investigate four primary objectives:
1. the incidence and trends of autoimmune diseases (AIDs) before and after the COVID-19 pandemic,
2. the association between COVID-19 vaccine status and the development of AIDs,
3. the clinical progression, treatment response, and recurrence of AIDs in post-COVID patients, and
4. the demographic and clinical profile, contributing factors, and spectrum of AID types identified during the post-pandemic period.
Retrospective 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.
The investigators hypothesize that:
1. the incidence of AIDs has increased in the post-COVID-19 era compared to the pre-pandemic period,
2. there is a positive association between COVID-19 vaccination and the onset of AIDs,
3. the clinical course and therapeutic response of AIDs in post-COVID patients differ from historical cases, and
4. unique demographic and clinical patterns characterize AID cases arising during the post-COVID period.
Accordingly, the study will yield four distinct analyses, each to be reported in a separate manuscript corresponding to the above objectives.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Autoimmune suspected cases
Cases suspected to have autoimmune diseases
No interventions assigned to this group
non - autoimmune suspected cases
non - autoimmune suspected cases
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* all age
Exclusion Criteria
ALL
No
Sponsors
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ClinAmygate
OTHER
Responsible Party
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Principal Investigators
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Emad R Issak, MD
Role: PRINCIPAL_INVESTIGATOR
Asalam Center
Locations
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Asalam
Maadi, Cairo Governorate, Egypt
Countries
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References
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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.
Other Identifiers
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PR0014
Identifier Type: -
Identifier Source: org_study_id
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