NCT04679584

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Nov 2020Dec 2030

Study Start

First participant enrolled

November 16, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

December 16, 2020

Last Update Submit

December 18, 2020

Conditions

COVID-19

Keywords

SARS-CoV-2COVID-19COVIDCoronalongterm morbidityQuality of Lifelongterm consequencesChronic impairmentChronic dysfunctionChronicitySequels

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (3)

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

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

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

Interventions

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

High-Resolution Platform (HAP) of the National Pandemic Cohort Network (NAPKON)Intersectoral Platform (SUEP) of the National Pandemic Cohort Network (NAPKON)Populationbased Platform (POP) of the National Pandemic Cohort Network (NAPKON)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • PCR-confirmed SARS-CoV-2 infection
  • living in one of the target areas
  • age at least 18 years
  • written informed consent

You may not qualify if:

  • Acute SARS-CoV-2 infection or reinfection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Wuerzburg

Würzburg, Bavaria, 97080, Germany

NOT YET RECRUITING

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

University Hospital Charité Berlin

Berlin, 10117, Germany

NOT YET RECRUITING

Related Publications (4)

  • Appel 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.

    PMID: 38871878DERIVED

  • Hartung TJ, Bahmer T, Chaplinskaya-Sobol I, Deckert J, Endres M, Franzpotter K, Geritz J, Haeusler KG, Hein G, Heuschmann PU, Hopff 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.

    PMID: 38333368DERIVED

  • 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.

    PMID: 35904671DERIVED

  • 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.

    PMID: 35875815DERIVED

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Stefan Schreiber, Prof. Dr.

    Internal Medicine Department I, UKSH Kiel

    STUDY DIRECTOR

Central Study Contacts

Stefan Schreiber, Prof. Dr.

CONTACT

0049 (0)431 500 22201s.schreiber@mucosa.de

Thomas Bahmer, Prof. Dr.

CONTACT

0049 (0) 431 500 62629thomas.bahmer@uksh.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 22, 2020

Study Start

November 16, 2020

Primary Completion

December 31, 2021

Study Completion (Estimated)

December 31, 2030

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Please see use and access conditions according to www.napkon.de

Locations

DE(3)