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:
ClinAmygate
Organization:
Study Overview
Official Title:
The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study explore the relationship between COVID-19 and the induction of autoimmune diseases.
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.
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.
Detailed Description:
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: