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
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 BerlinCharitéplatz 110117 BerlinGermany
- 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 KielProf. Dr. Stefan SchreiberArnold-Heller-Strasse 324105 KielGermany
- 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 KielProf. Dr. Thomas BahmerArnold-Heller-Straße 324105 KielGermany
- 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 KielProf. Dr. Stefan SchreiberArnold-Heller-Strasse 324105 KielGermany
- 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 MitteCharitéplatz 110117 BerlinGermany
- 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 KielSchwanenweg 2024105 KielGermany
- 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
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