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

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

Sponsors

Lead Sponsor: University Hospital Schleswig-Holstein

Collaborator: Charite University, Berlin, Germany
Wuerzburg University Hospital
German Federal Ministry of Education and Research

Source University Hospital Schleswig-Holstein
Brief Summary

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.

Detailed 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.

Overall Status Recruiting
Start Date 2020-11-16
Completion Date 2030-12-31
Primary Completion Date 2021-12-31
Study Type Observational
Primary Outcome
Measure Time Frame
Longterm morbidities and sequels of SARS-CoV-2 infections in the general population Preliminary results in 03/2021
Secondary Outcome
Measure Time Frame
Longterm quality of life of SARS-CoV-2 infected individuals recruited from the general population Preliminary results in 03/2021
Longterm health care utilization of SARS-CoV-2 infected individuals recruited from the general population Preliminary results in 03/2021
Enrollment 2000
Condition
Intervention

Intervention Type: Other

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

Description: Oberservatory Cohorts focusing (I) on subjects after SARS-CoV-2 infection that are recruited from the general population (POP), and on subjects with acute SARS-CoV-2 infections recruited (II) in university hospital high-care settings or (III) general health care

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Stefan Schreiber, Prof. Dr. Study Director Internal Medicine Department I, UKSH Kiel
Overall Contact

Last Name: Stefan Schreiber, Prof. Dr.

Phone: 0049 (0)431 500 22201

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator:
University Hospital Wuerzburg | Würzburg, Bavaria, 97080, Germany Not yet recruiting Peter Heuschmann, Prof. Dr. 0931 201 470308 [email protected] Stefan Stark, Prof. Dr. Sub-Investigator
University Hospital Schleswig-Holstein, Campus Kiel | Kiel, Schleswig-Holstein, 24105, Germany Recruiting Anne Hermes, Prof. Dr. 0049 (0) 431 500 30240 [email protected] Stefan Schreiber, Prof. Dr. Principal Investigator Thomas Bahmer, Prof. Dr. Sub-Investigator Lieb Wolfgang, Prof. Dr. Sub-Investigator Krawczak Michael, Prof. Dr. Sub-Investigator
University Hospital Charité Berlin | Berlin, 10117, Germany Not yet recruiting Thomas Keil, Prof. Dr. 0049 (0)30 450 529 902 [email protected]
Location Countries

Germany

Verification Date

2020-12-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Arm Group

Label: 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).

Label: 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).

Label: 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).

Acronym NAPKON-POP
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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