NCT05606198

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
641,407

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2023

Completed
Last Updated

September 11, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

November 2, 2022

Last Update Submit

September 7, 2023

Conditions

Virus Diseases

Outcome Measures

Primary Outcomes (42)

  • Incidence of Addison's disease

    Incidence of a diagnosis of Addison's disease recorded in outpatient or inpatient setting

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    At least 12 weeks after the infection by SARS-CoV-2

Study Arms (2)

COVID

641,407 patients with a SARS-CoV-2 infection in the year 2020.

Other: Exposed to a SARS-CoV-2 infection

Non-COVID

Matched patients with no SARS-CoV-2 infection during the study period.

Interventions

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.

COVID

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were collected from six different health insurances/research institutions in Germany in the year 2020.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Evidence-Based Healthcare, Technische Universität Dresden

Dresden, Saxony, 01307, Germany

Location

Related Publications (1)

  • 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.

    PMID: 37335408BACKGROUND

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Jochen Schmitt, MD, MPH

    Center for Evidence-Based Healthcare, Technische Universität Dresden

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 4, 2022

Study Start

May 1, 2022

Primary Completion

January 25, 2023

Study Completion

June 19, 2023

Last Updated

September 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)