Virus DiseasesPOINTED-ADNCT05606198
Post-COVID-19 Monitoring in Routine Health Insurance Data With Focus on Autoimmune Diseases (POINTED-AD)
An observational study of Virus Diseases, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) infection was in 2020 responsible for new disease related chronic conditions which have been referred to as Post-COVID. To date it is still unknown how common this condition is and how it might effect the working of the Immune system. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Virus Diseases
- What is being tested?
- Exposed to a SARS-CoV-2 infection
- How many people
- 641,407 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2022to 19 Jun 2023
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients were collected from six different health insurances/research institutions in Germany in the year 2020.
Who may be able to join
- At least one outpatient or inpatient diagnosis of COVID-19 with laboratory detection of the virus (ICD-10: U07.1!) in the year 2020
- Continuously insured with the respective health insurance between 2019-01-01/birth and 2021-06-30/death
Who cannot join
- Only an outpatient or inpatient diagnosis of COVID-19 without laboratory detection of the virus( ICD-10:U07.2!) till 30th of June 2021
- At least one outpatient or inpatient diagnosis of COVID-19 with laboratory detection of the virus (ICD-10: U07.1!) in the first half of the year 2021
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center for Evidence-Based Healthcare, Technische Universität Dresden
Dresden, Saxony, 01307
About this study
The SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) infection was in 2020 responsible for new disease related chronic conditions which have been referred to as Post-COVID. To date it is still unknown how common this condition is and how it might effect the working of the Immune system. The aim of the study is therefore to monitor the onset of autoimmune diseases in a large observational study consisting of German health insurance data.
Read the detailed description
SARS-CoV-2 is a virus of the coronavirus family, which includes a large number of viruses that can cause a wide variety of diseases in humans. The SARS-CoV-2 virus causes acute symptoms associated with the infection and can cause chronic conditions known as Post-COVID. To understand how the virus might effect the working of the Immune system a large observational study of health insurance data from Germany was set up. The exposed patients were identified by a diagnosis indicating a confirmed laboratory test for COVID-19.
The basic question concerns the burden of the Post-COVID condition. The study investigate which autoimmune diseases or groups of autoimmune diseases are more common in humans after the exposure to the virus compared to a matched unexposed cohort. Further will this be investigated in subgroups of the population.
- Conditions
- Virus Diseases
- Being tested
- Exposed to a SARS-CoV-2 infection
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposed to a SARS-CoV-2 infectionOther
The study compared humans exposed to the SARS-CoV-2 infection with a matched group of those not exposed. No Intervention was applied.
| Study group | Role | What they receive |
|---|---|---|
| COVID | 641,407 patients with a SARS-CoV-2 infection in the year 2020. Receives: Other: Exposed to a SARS-CoV-2 infection | |
| Non-COVID | Matched patients with no SARS-CoV-2 infection during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Addison's disease
Incidence of a diagnosis of Addison's disease recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Alopecia areata
Incidence of a diagnosis of Alopecia areata recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Autoimmune hemolytic anemia
Incidence of a diagnosis of Autoimmune hemolytic anemia recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Arteriitis temporalis
Incidence of a diagnosis of Arteriitis temporalis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Graves' disease
Incidence of a diagnosis of Graves' disease recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of ankylosing spondylitis
Incidence of a diagnosis of ankylosing spondylitis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Behcet's disease
Incidence of a diagnosis of Behcet's disease recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Churg-Strauss disease
Incidence of a diagnosis of Churg-Strauss disease recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Morbus Crohn
Incidence of a diagnosis of Morbus Crohn recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Dermatomyositis
Incidence of a diagnosis of Dermatomyositis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Diabetes type I
Incidence of a diagnosis of Diabetes type I recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Dermatitis herpetiformis (Duhring's disease)
Incidence of a diagnosis of Dermatitis herpetiformis (Duhring's disease) recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of atopic dermatitis
Incidence of a diagnosis of atopic dermatitis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Guillain-Barré-syndrome
Incidence of a diagnosis of Guillain-Barré-syndrome recorded in inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Goodpasture syndrome
Incidence of a diagnosis of Goodpasture syndrome recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Hashimoto's thyroiditis
Incidence of a diagnosis of Hashimoto's thyroiditis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Autoimmune Hepatitis
Incidence of a diagnosis of Autoimmune Hepatitis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Juvenile rheumatoid arthritis
Incidence of a diagnosis of Juvenile rheumatoid arthritis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Kawasaki syndrome
Incidence of a diagnosis of Kawasaki syndrome recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Cutaneous lupus erythematosus
Incidence of a diagnosis of Cutaneous lupus erythematosus recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Cryoglobulinemia
Incidence of a diagnosis of Cryoglobulinemia recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Systemic lupus erythematosus
Incidence of a diagnosis of Systemic lupus erythematosus recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Morphea
Incidence of a diagnosis of Morphea recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Multiple sclerosis
Incidence of a diagnosis of Multiple sclerosis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Myasthenia gravis
Incidence of a diagnosis of Myasthenia gravis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Necrotizing vasculopathy
Incidence of a diagnosis of Necrotizing vasculopathy recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Bullous pemphigoid
Incidence of a diagnosis of Bullous pemphigoid recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Pemphigus vulgaris
Incidence of a diagnosis of Pemphigus vulgaris recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Polyarteritis nodosa
Incidence of a diagnosis of Polyarteritis nodosa recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Polymyalgia rheumatica
Incidence of a diagnosis of Polymyalgia rheumatica recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Polymyositis
Incidence of a diagnosis of Polymyositis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Psoriasis
Incidence of a diagnosis of Psoriasis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Idiopathic thrombocytopenic purpura
Incidence of a diagnosis of Idiopathic thrombocytopenic purpura recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of rheumatoid arthritis
Incidence of a diagnosis of rheumatoid arthritis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Sarcoidosis
Incidence of a diagnosis of Sarcoidosis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Sjögren's syndrome
Incidence of a diagnosis of Sjögren's syndrome recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Takayasu arteritis
Incidence of a diagnosis of Takayasu arteritis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Ulcerative colitis
Incidence of a diagnosis of Ulcerative colitis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Vitiligo
Incidence of a diagnosis of Vitiligo recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of Wegener's disease
Incidence of a diagnosis of Wegener's disease recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of primary biliary cholangitis
Incidence of a diagnosis of primary biliary cholangitis recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Incidence of celiac disease
Incidence of a diagnosis of celiac disease recorded in outpatient or inpatient setting
Measured: At least 12 weeks after the infection by SARS-CoV-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 May 2022
- Primary completion25 Jan 2023
- Study completion19 Jun 2023
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 Virus DiseasesStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 641,407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH, BARMER Institut für Gesundheitssystemforschung (bifg), Techniker Krankenkasse, DAK Gesundheit, AOK PLUS, IKK Classic
- Responsible party
- Principal investigator, Falko Tesch, Technische Universität Dresden
- Investigators
- Jochen Schmitt, MD, MPH, Study director, Center for Evidence-Based Healthcare, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606198
- Sponsor's protocol ID
- POINTED-AD
- Acronym
- POINTED-AD
- Status last verified
- Jul 2023
- First submitted
- 2 Nov 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tesch F, Ehm F, Vivirito A, Wende D, Batram M, Loser F, Menzer S, Jacob J, Roessler M, Seifert M, Kind B, Konig C, Schulte C, Buschmann T, Hertle D, Ballesteros P, Bassler S, Bertele B, Bitterer T, Riederer C, Sobik F, Reitzle L, Scheidt-Nave C, Schmitt J. Incident autoimmune diseases in association with SARS-CoV-2 infection: a matched cohort study. Clin Rheumatol. 2023 Oct;42(10):2905-2914. doi: 10.1007/s10067-023-06670-0. Epub 2023 Jun 19.
PubMed 37335408
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-COVID-19 Monitoring in Routine Health Insurance Data With Focus on Autoimmune Diseases (POINTED-AD)
- ClinicalTrials.gov ID
- NCT05606198
- Acronym / sponsor ID
- POINTED-AD / POINTED-AD
- Conditions
- Virus Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 641,407 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH, BARMER Institut für Gesundheitssystemforschung (bifg), Techniker Krankenkasse, DAK Gesundheit, AOK PLUS, IKK Classic
- Study start
- 1 May 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 4 Nov 2022 (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 SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) infection was in 2020 responsible for new disease related chronic conditions which have been referred to as Post-COVID. To date it is still unknown how common this condition is and how it might effect the working of the Immune system. The aim of the study is therefore to monitor the onset of autoimmune diseases in a large observational study consisting of German health insurance data.
Detailed description
SARS-CoV-2 is a virus of the coronavirus family, which includes a large number of viruses that can cause a wide variety of diseases in humans. The SARS-CoV-2 virus causes acute symptoms associated with the infection and can cause chronic conditions known as Post-COVID. To understand how the virus might effect the working of the Immune system a large observational study of health insurance data from Germany was set up. The exposed patients were identified by a diagnosis indicating a confirmed laboratory test for COVID-19.
The basic question concerns the burden of the Post-COVID condition. The study investigate which autoimmune diseases or groups of autoimmune diseases are more common in humans after the exposure to the virus compared to a matched unexposed cohort. Further will this be investigated in subgroups of the population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID | – | Other: Exposed to a SARS-CoV-2 infection641,407 patients with a SARS-CoV-2 infection in the year 2020. |
| Non-COVID | – | –Matched patients with no SARS-CoV-2 infection during the study period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients were collected from six different health insurances/research institutions in Germany in the year 2020.
Key inclusion criteria (2 listed)
- At least one outpatient or inpatient diagnosis of COVID-19 with laboratory detection of the virus (ICD-10: U07.1!) in the year 2020
- Continuously insured with the respective health insurance between 2019-01-01/birth and 2021-06-30/death
Key exclusion criteria (2 listed)
- Only an outpatient or inpatient diagnosis of COVID-19 without laboratory detection of the virus( ICD-10:U07.2!) till 30th of June 2021
- At least one outpatient or inpatient diagnosis of COVID-19 with laboratory detection of the virus (ICD-10: U07.1!) in the first half of the year 2021
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposed to a SARS-CoV-2 infectionThe study compared humans exposed to the SARS-CoV-2 infection with a matched group of those not exposed. No Intervention was applied. | Other | COVID |
Primary outcome
Incidence of Addison's disease
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Addison's disease recorded in outpatient or inpatient setting
Incidence of Alopecia areata
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Alopecia areata recorded in outpatient or inpatient setting
Incidence of Autoimmune hemolytic anemia
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Autoimmune hemolytic anemia recorded in outpatient or inpatient setting
Incidence of Arteriitis temporalis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Arteriitis temporalis recorded in outpatient or inpatient setting
Incidence of Graves' disease
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Graves' disease recorded in outpatient or inpatient setting
Incidence of ankylosing spondylitis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of ankylosing spondylitis recorded in outpatient or inpatient setting
Incidence of Behcet's disease
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Behcet's disease recorded in outpatient or inpatient setting
Incidence of Churg-Strauss disease
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Churg-Strauss disease recorded in outpatient or inpatient setting
Incidence of Morbus Crohn
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Morbus Crohn recorded in outpatient or inpatient setting
Incidence of Dermatomyositis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Dermatomyositis recorded in outpatient or inpatient setting
Incidence of Diabetes type I
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Diabetes type I recorded in outpatient or inpatient setting
Incidence of Dermatitis herpetiformis (Duhring's disease)
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Dermatitis herpetiformis (Duhring's disease) recorded in outpatient or inpatient setting
Incidence of atopic dermatitis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of atopic dermatitis recorded in outpatient or inpatient setting
Incidence of Guillain-Barré-syndrome
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Guillain-Barré-syndrome recorded in inpatient setting
Incidence of Goodpasture syndrome
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Goodpasture syndrome recorded in outpatient or inpatient setting
Incidence of Hashimoto's thyroiditis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Hashimoto's thyroiditis recorded in outpatient or inpatient setting
Incidence of Autoimmune Hepatitis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Autoimmune Hepatitis recorded in outpatient or inpatient setting
Incidence of Juvenile rheumatoid arthritis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Juvenile rheumatoid arthritis recorded in outpatient or inpatient setting
Incidence of Kawasaki syndrome
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Kawasaki syndrome recorded in outpatient or inpatient setting
Incidence of Cutaneous lupus erythematosus
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Cutaneous lupus erythematosus recorded in outpatient or inpatient setting
Incidence of Cryoglobulinemia
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Cryoglobulinemia recorded in outpatient or inpatient setting
Incidence of Systemic lupus erythematosus
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Systemic lupus erythematosus recorded in outpatient or inpatient setting
Incidence of Morphea
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Morphea recorded in outpatient or inpatient setting
Incidence of Multiple sclerosis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Multiple sclerosis recorded in outpatient or inpatient setting
Incidence of Myasthenia gravis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Myasthenia gravis recorded in outpatient or inpatient setting
Incidence of Necrotizing vasculopathy
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Necrotizing vasculopathy recorded in outpatient or inpatient setting
Incidence of Bullous pemphigoid
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Bullous pemphigoid recorded in outpatient or inpatient setting
Incidence of Pemphigus vulgaris
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Pemphigus vulgaris recorded in outpatient or inpatient setting
Incidence of Polyarteritis nodosa
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Polyarteritis nodosa recorded in outpatient or inpatient setting
Incidence of Polymyalgia rheumatica
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Polymyalgia rheumatica recorded in outpatient or inpatient setting
Incidence of Polymyositis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Polymyositis recorded in outpatient or inpatient setting
Incidence of Psoriasis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Psoriasis recorded in outpatient or inpatient setting
Incidence of Idiopathic thrombocytopenic purpura
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Idiopathic thrombocytopenic purpura recorded in outpatient or inpatient setting
Incidence of rheumatoid arthritis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of rheumatoid arthritis recorded in outpatient or inpatient setting
Incidence of Sarcoidosis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Sarcoidosis recorded in outpatient or inpatient setting
Incidence of Sjögren's syndrome
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Sjögren's syndrome recorded in outpatient or inpatient setting
Incidence of Takayasu arteritis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Takayasu arteritis recorded in outpatient or inpatient setting
Incidence of Ulcerative colitis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Ulcerative colitis recorded in outpatient or inpatient setting
Incidence of Vitiligo
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Vitiligo recorded in outpatient or inpatient setting
Incidence of Wegener's disease
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Wegener's disease recorded in outpatient or inpatient setting
Incidence of primary biliary cholangitis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of primary biliary cholangitis recorded in outpatient or inpatient setting
Incidence of celiac disease
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of celiac disease recorded in outpatient or inpatient setting
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 11 Sep 2023.
- Background: PubMed 37335408Tesch F, Ehm F, Vivirito A, Wende D, Batram M, Loser F, Menzer S, Jacob J, Roessler M, Seifert M, Kind B, Konig C, Schulte C, Buschmann T, Hertle D, Ballesteros P, Bassler S, Bertele B, Bitterer T, Riederer C, Sobik F, Reitzle L, Scheidt-Nave C, Schmitt J. Incident autoimmune diseases in association with SARS-CoV-2 infection: a matched cohort study. Clin Rheumatol. 2023 Oct;42(10):2905-2914. doi: 10.1007/s10067-023-06670-0. Epub 2023 Jun 19.
- Individual participant dataSharing planned: No
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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.
Jochen Schmitt, MD, MPH study director
Center for Evidence-Based Healthcare, Technische Universität Dresden
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 Virus Diseases, run by Technische Universität Dresden at 1 site in Germany.
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 2 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 11 Sep 2023. 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 Germany. 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 of Addison's disease (time frame: At least 12 weeks after the infection by SARS-CoV-2). The study lists 42 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 NCT05606198, 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 11 Sep 2023.