Post-COVID-19 Monitoring in Routine Health Insurance Data With Focus on Autoimmune Diseases (POINTED-AD) (POINTED-AD)

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.

Study Overview

• Status: Completed
• Conditions: Virus Diseases
• Intervention / Treatment: Other: Exposed to a SARS-CoV-2 infection

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 Type: Observational
• Enrollment (Actual): 641407

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Center For Evidence-Based Healthcare, Technische Universität Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-COVID; Matched patients with no SARS-CoV-2 infection during the study period.
COVID; 641,407 patients with a SARS-CoV-2 infection in the year 2020.	Other: Exposed to a SARS-CoV-2 infection; The study compared humans exposed to the SARS-CoV-2 infection with a matched group of those not exposed. No Intervention was applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: Techniker Krankenkasse; InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH; BARMER Institut für Gesundheitssystemforschung (bifg); DAK Gesundheit; AOK PLUS; IKK Classic
• Investigators: Study Director: Jochen Schmitt, MD, MPH, Center For Evidence-Based Healthcare, Technische Universität Dresden

Publications and helpful links

General 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 Jun 19. doi: 10.1007/s10067-023-06670-0. Online ahead of print. Erratum In: Clin Rheumatol. 2023 Jul 5;:

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): June 19, 2023

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Virus Diseases; Autoimmune Diseases
• Other Study ID Numbers: POINTED-AD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No