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Completed

NCT Number: NCT04558203

The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Asalam

Maadi, Cairo Governorate, 11433, Egypt

About this study

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:

  • the incidence and trends of autoimmune diseases (AIDs) before and after the COVID-19 pandemic,
  • the association between COVID-19 vaccine status and the development of AIDs,
  • the clinical progression, treatment response, and recurrence of AIDs in post-COVID patients, and
  • 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:

  • the incidence of AIDs has increased in the post-COVID-19 era compared to the pre-pandemic period,
  • there is a positive association between COVID-19 vaccination and the onset of AIDs,
  • the clinical course and therapeutic response of AIDs in post-COVID patients differ from historical cases, and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all gender
  • all age

Exclusion criteria

  • Those who refused to participate

Treatment and study plan

Primary outcomes

  1. Incidence Rate of Autoimmune Diseasee

    Time frame: 2016-2024

    The number of new AID cases per 100,000 population before and after COVID-19, analyzed using retrospective and prospective data.

  2. Disease severity

    Time frame: one week

    Severity as mild, moderate, severe according to type of AIDs

  3. recurrence of AIDs

    Time frame: one year

    number of recurrence of the disease within the follow up period

  4. response to therapy in the acute phase

    Time frame: within 4 weeks

    good response, weak response that need escalation of the dose of corticosteroids, no response

Secondary outcomes

  1. recurrence as another auto-immune disease

    Time frame: Up to 4 years

    recurrence of different auto-immune disease

  2. change in inflammatory markers

    Time frame: Two-months to Twelve months

    behavior of laboratory data of C-reactive protein, sedimentation rate, ferritine

  3. incidence of other complications

    Time frame: Two-months to Twelve months

    incidence of other complications

Sponsors and collaborators

Lead sponsor

ClinAmygate

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2020
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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