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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Stefan Schreiber, Prof. Dr.; Phone Number: 0049 (0)431 500 22201; Email: s.schreiber@mucosa.de
• Study Contact Backup: Name: Thomas Bahmer, Prof. Dr.; Phone Number: 0049 (0) 431 500 62629; Email: thomas.bahmer@uksh.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Not yet recruiting
    • University Hospital Charite Berlin
    • Contact: Thomas Keil, Prof. Dr.; Phone Number: 0049 (0)30 450 529 902; Email: thomas.keil@charite.de
    • Contact: Lilian Krist, Dr.; Phone Number: 0049 (0)30 450 529 902; Email: lilian.krist@charite.de
  • Bavaria
    • Würzburg, Bavaria, Germany, 97080
      • Not yet recruiting
      • University Hospital Wuerzburg
      • Contact: Peter Heuschmann, Prof. Dr.; Phone Number: 0931 201 470308; Email: E_Heuschma_P@ukw.de
      • Contact: Jens-Peter Reese, Prof. Dr.; Phone Number: 0931 201 470308
      • Sub-Investigator: Stefan Stark, Prof. Dr.
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Recruiting
      • University Hospital Schleswig-Holstein, Campus Kiel
      • Contact: Thomas Bahmer, Prof. Dr.; Phone Number: 0049 (0) 431 500 62629; Email: thomas.bahmer@uksh.de
      • Contact: Anne Hermes, Prof. Dr.; Phone Number: 0049 (0) 431 500 30240; Email: info@covidom.de
      • Principal Investigator: Stefan Schreiber, Prof. Dr.
      • Sub-Investigator: Thomas Bahmer, Prof. Dr.
      • Sub-Investigator: Lieb Wolfgang, Prof. Dr.
      • Sub-Investigator: Krawczak Michael, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Populationbased Platform (POP) of the National Pandemic Cohort Network (NAPKON); Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensu data set, GECCO) with other NAPKON study platforms (HAP, SUEP).	Other: Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings; 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
High-Resolution Platform (HAP) of the National Pandemic Cohort Network (NAPKON); Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensu data set, GECCO) with other NAPKON study platforms (POP, SUEP).	Other: Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings; 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
Intersectoral Platform (SUEP) of the National Pandemic Cohort Network (NAPKON); Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensu data set, GECCO) with other NAPKON study platforms (HAP, POP).	Other: Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longterm morbidities and sequels of SARS-CoV-2 infections in the general population	Chronic organ impairments, especially of the lungs, heart, liver, central nervous system, smell and taste or psychological well-being bases on functional assessments (i.e. lung function including forced spirometry, bodyplethysmography, diffusing capacity for CO, FeNO, echocardiography, testing of smell and taste, neurological assessment, psychological assessment) and biomarker studies (blood, nasopharyngeal swabs, urin, stool)	Preliminary results in 03/2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longterm quality of life of SARS-CoV-2 infected individuals recruited from the general population	Longitudinal assessment of general and health-related quality of Life, as well as health status in SARS-CoV-2 infected individuals of different severity grades	Preliminary results in 03/2021
Longterm health care utilization of SARS-CoV-2 infected individuals recruited from the general population	Longitudinal assessment of health-care utilization based on insurance data in SARS-CoV-2 infected individuals of different severity grades	Preliminary results in 03/2021

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Collaborators: Charite University, Berlin, Germany; German Federal Ministry of Education and Research; Wuerzburg University Hospital
• Investigators: Study Director: Stefan Schreiber, Prof. Dr., Internal Medicine Department I, UKSH Kiel

Publications and helpful links

General Publications

• Schons M, Pilgram L, Reese JP, Stecher M, Anton G, Appel KS, Bahmer T, Bartschke A, Bellinghausen C, Bernemann I, Brechtel M, Brinkmann F, Brunn C, Dhillon C, Fiessler C, Geisler R, Hamelmann E, Hansch S, Hanses F, Hanss S, Herold S, Heyder R, Hofmann AL, Hopff SM, Horn A, Jakob C, Jiru-Hillmann S, Keil T, Khodamoradi Y, Kohls M, Kraus M, Krefting D, Kunze S, Kurth F, Lieb W, Lippert LJ, Lorbeer R, Lorenz-Depiereux B, Maetzler C, Miljukov O, Nauck M, Pape D, Puntmann V, Reinke L, Rommele C, Rudolph S, Sass J, Schafer C, Schaller J, Schattschneider M, Scheer C, Scherer M, Schmidt S, Schmidt J, Seibel K, Stahl D, Steinbeis F, Stork S, Tauchert M, Tebbe JJ, Thibeault C, Toepfner N, Ungethum K, Vadasz I, Valentin H, Wiedmann S, Zoller T, Nagel E, Krawczak M, von Kalle C, Illig T, Schreiber S, Witzenrath M, Heuschmann P, Vehreschild JJ; NAPKON Research Group. The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics. Eur J Epidemiol. 2022 Aug;37(8):849-870. doi: 10.1007/s10654-022-00896-z. Epub 2022 Jul 29.
• Bahmer T, Borzikowsky C, Lieb W, Horn A, Krist L, Fricke J, Scheibenbogen C, Rabe KF, Maetzler W, Maetzler C, Laudien M, Frank D, Ballhausen S, Hermes A, Miljukov O, Haeusler KG, Mokhtari NEE, Witzenrath M, Vehreschild JJ, Krefting D, Pape D, Montellano FA, Kohls M, Morbach C, Stork S, Reese JP, Keil T, Heuschmann P, Krawczak M, Schreiber S; NAPKON study group. Severity, predictors and clinical correlates of Post-COVID syndrome (PCS) in Germany: A prospective, multi-centre, population-based cohort study. EClinicalMedicine. 2022 Jul 18;51:101549. doi: 10.1016/j.eclinm.2022.101549. eCollection 2022 Sep.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Quality of Life; COVID-19; COVID; Sequels; Corona; longterm morbidity; longterm consequences; Chronic impairment; Chronic dysfunction; Chronicity
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COVIDOM-Protokoll_V01F_2020-10; DRKS00023742 (Other Identifier: Deutsches Register Klinischer Studien (German Registry for Clinical Studies))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Please see use and access conditions according to www.napkon.de

Drug and device information, study documents

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