COVID-19NAPKON-POPNCT04679584
COVIDOM: Longterm Morbidity of SARS-CoV-2 Infection and COVID-19 Disease - Consequences for Health Status and Quality of Life
An observational study of COVID-19, run by University Hospital Schleswig-Holstein at 3 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings
- How many people
- 2,000 participants
- Where
- 3 sitesGermany
- Study dates
- 16 Nov 2020to 31 Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- PCR-confirmed SARS-CoV-2 infection
- living in one of the target areas
- age at least 18 years
- written informed consent
Who cannot join
- Acute SARS-CoV-2 infection or reinfection
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Not yet recruiting
University Hospital Charité Berlin
Berlin, 10117
Thomas Keil, Prof. Dr., 0049 (0)30 450 529 902, thomas.keil@charite.de
Lilian Krist, Dr., 0049 (0)30 450 529 902, lilian.krist@charite.de
- Recruiting
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
Anne Hermes, Prof. Dr., 0049 (0) 431 500 30240, info@covidom.de
Thomas Bahmer, Prof. Dr., 0049 (0) 431 500 62629, thomas.bahmer@uksh.de
- Not yet recruiting
University Hospital Wuerzburg
Würzburg, Bavaria, 97080
Peter Heuschmann, Prof. Dr., 0931 201 470308, E_Heuschma_P@ukw.de
Jens-Peter Reese, Prof. Dr., 0931 201 470308
About this study
Official title: 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:
Read more
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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- COVID-19
- Being tested
- Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings
- Keywords
- SARS-CoV-2, COVID-19, COVID, Corona, longterm morbidity, Quality of Life, longterm consequences, Chronic impairment, Chronic dysfunction, Chronicity, Sequels
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settingsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) | Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensu data set, GECCO) with other NAPKON study platforms (POP, SUEP). Receives: 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) | Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensu data set, GECCO) with other NAPKON study platforms (HAP, POP). Receives: Other: Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Preliminary results in 03/2021
Secondary outcomes (2)
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
Measured: 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
Measured: Preliminary results in 03/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start16 Nov 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Wuerzburg University Hospital, German Federal Ministry of Education and Research
- Responsible party
- Sponsor
- Investigators
- Stefan Schreiber, Prof. Dr., Study director, Internal Medicine Department I, UKSH Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679584
- Sponsor's protocol ID
- COVIDOM-Protokoll_V01F_2020-10
- Other IDs
- DRKS00023742
- Acronym
- NAPKON-POP
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Please see use and access conditions according to www.napkon.de
Publications
Gutzeit J, Weiss M, Bahmer T, Lieb W, Schreiber S, Vehreschild JJ, Nurnberger C, Putz SM, Heim E, Russ AK, Dempfle A, Krawczak M, Poick S, Schafer A, Morbach C, Lehmann C, Polidori MC, Reese JP, Zoller T, Krist L, Heyckendorf J, Reinke LM, Deckert J, Hein G; NAPKON Study Group. Long-term trends in Post-COVID severity: a machine learning analysis from the POP/COVIDOM cohort of the German NAPKON Cohort Network. EClinicalMedicine. 2026 Mar 10;93:103822. doi: 10.1016/j.eclinm.2026.103822. eCollection 2026 Mar.
PubMed 41852926Appel KS, Lee CH, Nunes de Miranda SM, Maier D, Reese JP, Anton G, Bahmer T, Ballhausen S, Balzuweit B, Bellinghausen C, Blumentritt A, Brechtel M, Chaplinskaya-Sobol I, Erber J, Fiedler K, Geisler R, Heyder R, Illig T, Kohls M, Kollek J, Krist L, Lorbeer R, Miljukov O, Mitrov L, Nurnberger C, Pape C, Pley C, Schafer C, Schaller J, Schattschneider M, Scherer M, Schulze N, Stahl D, Stubbe HC, Tamminga T, Tebbe JJ, Vehreschild MJGT, Wiedmann S, Vehreschild JJ. A precise performance-based reimbursement model for the multi-centre NAPKON cohorts - development and evaluation. Sci Rep. 2024 Jun 13;14(1):13607. doi: 10.1038/s41598-024-63945-5.
PubMed 38871878Hartung TJ, Bahmer T, Chaplinskaya-Sobol I, Deckert J, Endres M, Franzpotter K, Geritz J, Haeusler KG, Hein G, Heuschmann PU, Putz SM, Horn A, Keil T, Krawczak M, Krist L, Lieb W, Maetzler C, Montellano FA, Morbach C, Neumann C, Nurnberger C, Russ AK, Schmidbauer L, Schmidt S, Schreiber S, Steigerwald F, Stork S, Zoller T, Maetzler W, Finke C; NAPKON Study Group. Predictors of non-recovery from fatigue and cognitive deficits after COVID-19: a prospective, longitudinal, population-based study. EClinicalMedicine. 2024 Feb 3;69:102456. doi: 10.1016/j.eclinm.2024.102456. eCollection 2024 Mar.
PubMed 38333368Schons 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, Putz 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.
PubMed 35904671Bahmer 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.
PubMed 35875815