COVIDOM: Longterm Morbidity of SARS-CoV-2 Infection and COVID-19 Disease - Consequences for Health Status and Quality of Life (NAPKON-POP)

University Hospital Schleswig-Holstein (UKSH)

Status: Enrolling

Conditions: COVID-19

Treatments: Other: Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings

Study type: Observational

Funder types: Other

Identifiers

NCT04679584

COVIDOM-Protokoll_V01F_2020-10

DRKS00023742 (Other Identifier)

Details and patient eligibility

About

COVID-19 is a novel disease caused by SARS-CoV-2 that primarily affects the lungs but also various other organs of the body already in early stages of the disease. Due to the multiple organ involvements in the acute phase, it is conceivable that - in a significant proportion of patients - longterm sequels in various organ systems might occur, thereby impacting the individual's health status and quality of life; and posing a relevant burden to the resources of the health care system

Assessment of SARS-CoV-2-longterm morbidity and sequels on the population level:

In order to identify and treat these sequels in a timely fashion and to get a sense of the prevalence of such SARS-CoV-2 sequels on the population level, it is important to collect follow-up data and to comprehensively re-examine a population-representative sample of SARS-CoV-2 infected individuals.

Within the COVIDOM study we will conduct deep clinical and biochemical phenotyping in population-representative samples in Germany. This will allow novel insights into disease pathogenesis and chronicity of virus infections.

Full description

Background:

COVID-19 is a novel disease caused by SARS-CoV-2. Severity of infection in the acute phase ranges from asymptomatic to critically ill and fatal courses of the disease. Besides the acute respiratory distress syndrome (ARDS), also thromboembolic events and acute damages of other organs are contributing to severe and critical courses of the disease in the acute phase of the infection.

It is, however, largely unknown whether and to what extent different organs are affected in individuals with milder courses of the disease.

Hypotheses:

1. Across all severity stages in the acute phase, SARS-CoV-2 infection causes longterm damages in various organ systems in a significant proportion of patients.
2. Beyond the damages directly caused by the infection, also the behavioral changes implemented to reduce the spread of the virus might impact an individual's health status and quality of life.
3. The infection itself and the pandemic in general results in increased use of health care resources.

Methods:

SARS-CoV-2 infected individuals in defined geographic regions will be contacted through the responsible health authorities and will be informed about the study and invited to participate. These individuals will presumably represent all severity grades in the initial phase of the infection (asymptomatic, uncomplicated, complicated, critical course of disease) and each of them will be offered a detailed clinical examination program that Includes structural and functional assessment of various organ systems (lungs, cardiovascular, CNS including smell/tase, liver), a comprehensive medical history, as well as psychological and psychiatric assessments.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PCR-confirmed SARS-CoV-2 infection
• living in one of the target areas
• age at least 18 years
• written informed consent

Exclusion criteria

• Acute SARS-CoV-2 infection or reinfection

Trial design

2,000 participants in 3 patient groups

Populationbased Platform (POP) of the National Pandemic Cohort Network (NAPKON)

Description:

Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensu data set, GECCO) with other NAPKON study platforms (HAP, SUEP).

Treatment:

Other: Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings

High-Resolution Platform (HAP) of the National Pandemic Cohort Network (NAPKON)

Description:

Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensu data set, GECCO) with other NAPKON study platforms (POP, SUEP).

Treatment:

Other: Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings

Intersectoral Platform (SUEP) of the National Pandemic Cohort Network (NAPKON)

Description:

Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensu data set, GECCO) with other NAPKON study platforms (HAP, POP).

Treatment:

Other: Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings