Covid19NCT04558203
The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice
An observational study of Covid19, run by ClinAmygate at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 10,510 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Sep 2020to 5 Mar 2025
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- all gender
- all age
Who cannot join
- Those who refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
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:
- trends in AID incidence before and after the COVID-19 pandemic,
- the demographic and clinical profile of AID patients in the post-COVID-19 era,
- the association between COVID-19 vaccine status and the development of AIDs, and
- the clinical course, response to therapy, and long-term outcomes of AIDs in post-COVID patients compared to pre-pandemic cases.
Read the 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:
- 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.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Autoimmune suspected cases | Cases suspected to have autoimmune diseases | |
| non - autoimmune suspected cases | non - autoimmune suspected cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2016-2024
Disease severity
Severity as mild, moderate, severe according to type of AIDs
Measured: one week
recurrence of AIDs
number of recurrence of the disease within the follow up period
Measured: one year
response to therapy in the acute phase
good response, weak response that need escalation of the dose of corticosteroids, no response
Measured: within 4 weeks
Secondary outcomes (3)
recurrence as another auto-immune disease
recurrence of different auto-immune disease
Measured: Up to 4 years
change in inflammatory markers
behavior of laboratory data of C-reactive protein, sedimentation rate, ferritine
Measured: Two-months to Twelve months
incidence of other complications
incidence of other complications
Measured: Two-months to Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start22 Sep 2020
- Primary completion5 Jan 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 10,510 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- ClinAmygate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emad R Issak, MD, Principal investigator, Asalam Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558203
- Sponsor's protocol ID
- PR0014
- Status last verified
- Apr 2025
- First submitted
- 19 Sep 2020
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32535093
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice
- ClinicalTrials.gov ID
- NCT04558203
- Acronym / sponsor ID
- PR0014
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,510 participants (actual)
- Lead sponsor
- ClinAmygateUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- trends in AID incidence before and after the COVID-19 pandemic,
- the demographic and clinical profile of AID patients in the post-COVID-19 era,
- the association between COVID-19 vaccine status and the development of AIDs, and
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autoimmune suspected cases | – | –Cases suspected to have autoimmune diseases |
| non - autoimmune suspected cases | – | –non - autoimmune suspected cases |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- all gender
- all age
Key exclusion criteria (1 listed)
- Those who refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Disease severity
Time frame: one week
Severity as mild, moderate, severe according to type of AIDs
recurrence of AIDs
Time frame: one year
number of recurrence of the disease within the follow up period
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
3 secondary outcomes
recurrence as another auto-immune disease
Time frame: Up to 4 years
change in inflammatory markers
Time frame: Two-months to Twelve months
incidence of other complications
Time frame: Two-months to Twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Background: PubMed 32535093Ehrenfeld 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emad R Issak, MD principal investigator
Asalam Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by ClinAmygate at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rate of Autoimmune Diseasee (time frame: 2016-2024). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04558203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.