COVIDOM: Longterm morbidity of SARS-CoV-2 infection and COVID-19 disease – consequences for health status and quality of life

Organizational Data

DRKS-ID:
DRKS00023742
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2020-12-10
Last update in DRKS:
2023-01-27
Registration type:
Retrospective

Acronym/abbreviation of the study

NAPKON - POP (National Pandemic Cohort Network - Population Based Platform)

URL of the study

http://www.covidom.de

Brief summary in lay language

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.

Brief summary in scientific language

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/taste, liver), a comprehensive medical history, as well as psychological and psychiatric assessments.

Health condition or problem studied

Free text:
COVID19
Free text:
SARS-CoV-2 infection
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Populationbased Platform (POP) of the National Pandemic Cohort Network (NAPKON): recruitment of patients that are representative for a given region of the participating centers at a timepoint 6 months after acute SARS-CoV-2 infection of different severities; retrospective characterization of the acute phase of the disease and prospective characterization of anamnestic, functional and molecular characteristics of the patients; harmonized datasets with SÜP and HAP.
Arm 2:
High-Resolution Platform (HAP) of the National Pandemic Cohort Network (NAPKON): recruitment in the acute phase of the disease in the participating centers; prospective deep characterization of anamnestic, functional and molecular characteristics of the patients; harmonized datasets with POP and SÜP.
Arm 3:
Intersectoral Platform (SÜP) of the National Pandemic Cohort Network (NAPKON): recruitment in the acute phase of the disease in the participating centers; prospective broad characterization of anamnestic, functional and molecular characteristics of the patients; harmonized datasets with POP and HAP.

Endpoints

Primary outcome:
Longterm morbidities and sequels of SARS-CoV-2 infections in the general population 6 and 18 months after infection
Secondary outcome:
(1) Reduced Quality of Life and Health Status (2) Increased healthcare utilization

Study Design

Purpose:
Prognosis
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Longitudinal study
Study type non-interventional:
Epidemiological study

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Universitätsklinikum Würzburg (UKW) Würzburg
  • Medical center Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel Kiel
  • Medical center Charité Universitätsmedizin Berlin

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2020-11-16
Planned study completion date:
2025-06-30
Actual Study Completion Date:
No Entry
Target Sample Size:
3500
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional 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

Addresses

Primary Sponsor

Address:
Forschungsnetzwerk der Universitätsmedizin zu COVID-19 (Netzwerk Universitätsmedizin, NUM), Koordinierungsstelle Charité Berlin
Charitéplatz 1
10117 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Medizinische Klinik I, UKSH Campus Kiel
Prof. Dr. Stefan Schreiber
Arnold-Heller-Strasse 3
24105 Kiel
Germany
Telephone:
0049 431 500 62629
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.uksh.de

Contact for Public Queries

Address:
Institut für Epidemiologie, UKSH Kiel
Prof. Dr. Thomas Bahmer
Arnold-Heller-Straße 3
24105 Kiel
Germany
Telephone:
0431 500 22201
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.covidom.de

Principal Investigator

Address:
Medizinische Klinik I, UKSH Campus Kiel
Prof. Dr. Stefan Schreiber
Arnold-Heller-Strasse 3
24105 Kiel
Germany
Telephone:
0049 431 500 62629
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.uksh.de

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
Forschungsnetzwerk der Universitätsmedizin zu COVID-19 (Netzwerk Universitätsmedizin, NUM), Koordinierungsstelle Berlin, Charité Campus Charité Mitte
Charitéplatz 1
10117 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.charite.de

Ethics Committee

Address Ethics Committee

Address:
Ethik-Kommission der Medizinischen Fakultät der Christian-Albrechts-Universität zu Kiel
Schwanenweg 20
24105 Kiel
Germany
Telephone:
+49-431-50014191
Fax:
+49-431-50014195
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2020-07-09
Ethics committee number:
D 537/20
Vote of the Ethics Committee:
Approved
Date of the vote:
2020-07-16

Further identification numbers

Other primary registry ID:
NCT04679584 - clinicaltrials.gov
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
Please see: www.napkon.de

Study protocol and other study documents

Study protocols:
Cohort description NAPKON-POP/ COVIDOM
Rational and Study Design NAPKON
Study abstract:
No Entry
Other study documents:
Development of the Post-COVID-Syndrome Score (PCS Score)
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
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, Störk 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. PMID: 35875815; PMCID: PMC9289961.
Hartung TJ, Neumann C, Bahmer T, Chaplinskaya-Sobol I, Endres M, Geritz J, Haeusler KG, Heuschmann PU, Hildesheim H, Hinz A, Hopff S, Horn A, Krawczak M, Krist L, Kudelka J, Lieb W, Maetzler C, Mehnert-Theuerkauf A, Montellano FA, Morbach C, Schmidt S, Schreiber S, Steigerwald F, Störk S, Maetzler W, Finke C. Fatigue and cognitive impairment after COVID-19: A prospective multicentre study. EClinicalMedicine. 2022 Sep 17;53:101651. doi: 10.1016/j.eclinm.2022.101651. PMID: 36133318; PMCID: PMC9482331.
Winkelmann S, Korth A, Voss B, Nasr MA, Behrend N, Pudszuhn A, Hofmann VM, Schendzielorz P, Maetzler C, Hermes A, Borzikowsky C, Bahmer T, Lieb W, Schreiber S, Störk S, Montellano FA, Witzenrath M, Keil T, Krawczak M, Laudien M, Napkon Study Group OBOT. Persisting chemosensory dysfunction in COVID-19 - a cross-sectional population-based survey. Rhinology. 2022 Oct 27. doi: 10.4193/Rhin22.176. Epub ahead of print. PMID: 36323438.
Date of first publication of study results:
2022-07-18
DRKS entry published for the first time with results:
2023-01-27

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry