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

NCT04558203 | Completed DMC

• 1 other identifier: PR0014
• Study Type: observational
• Target: 10,510
• Locations: 1 country
• Sites: 1

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. 1.trends in AID incidence before and after the COVID-19 pandemic,
2. 2.the demographic and clinical profile of AID patients in the post-COVID-19 era,
3. 3.the association between COVID-19 vaccine status and the development of AIDs, and
4. 4.the clinical course, response to therapy, and long-term outcomes of AIDs in post-COVID patients compared to pre-pandemic cases.

Conditions

Covid19

Outcome Measures

Primary Outcomes (4)

• Incidence Rate of Autoimmune Diseasee

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

  2016-2024

• Disease severity

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

  one week

• recurrence of AIDs

  number of recurrence of the disease within the follow up period

  one year

• response to therapy in the acute phase

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

  within 4 weeks

Secondary Outcomes (3)

• recurrence as another auto-immune disease

  Up to 4 years

• change in inflammatory markers

  Two-months to Twelve months

• incidence of other complications

  Two-months to Twelve months

Study Arms (2)

Autoimmune suspected cases

Cases suspected to have autoimmune diseases

non - autoimmune suspected cases

non - autoimmune suspected cases

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• all gender
• all age

You may not qualify if:

• Those who refused to participate

Sponsors & Collaborators

• ClinAmygate: lead

Study Sites (1)

Asalam

Maadi, Cairo Governorate, 11433, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32535093 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Emad R Issak, MD

  Asalam Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: September 22, 2020
• Study Start: September 22, 2020
• Primary Completion: January 5, 2025
• Study Completion: March 5, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

EG (1)