Clinical trial NCT04558203: The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice
Official title: The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: ClinAmygate
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 10510
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study population are all patients came to the center with or without symptoms and signs suspected to be AID during the study period

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.

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.

Eligibility criteria: Inclusion Criteria:

* all gender
* all age

Exclusion Criteria:

* Those who refused to participate

Primary outcomes:
measure: Incidence Rate of Autoimmune Diseasee
timeFrame: 2016-2024
measure: Disease severity
timeFrame: one week
measure: recurrence of AIDs
timeFrame: one year
measure: response to therapy in the acute phase
timeFrame: within 4 weeks
Secondary outcomes:
measure: recurrence as another auto-immune disease
timeFrame: Up to 4 years
measure: change in inflammatory markers
timeFrame: Two-months to Twelve months
measure: incidence of other complications
timeFrame: Two-months to Twelve months
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Asalam
state: Cairo
Study officials:
affiliation: Asalam Center
name: Emad R Issak, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.