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

Technische Universität Dresden

Status: Completed

Conditions: Virus Diseases

Treatments: Other: Exposed to a SARS-CoV-2 infection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05606198

POINTED-AD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 641,407 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

641,407 participants in 2 patient groups

COVID

Description:

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

Treatment:

Other: Exposed to a SARS-CoV-2 infection

Non-COVID

Description:

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