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

Official title

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

Overview

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.

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.

Interventions

• 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

Primary outcome measures

• Longterm morbidities and sequels of SARS-CoV-2 infections in the general population [Time frame: Preliminary results in 03/2021]

Secondary outcome measures (2)

• Longterm quality of life of SARS-CoV-2 infected individuals recruited from the general population [Time frame: Preliminary results in 03/2021]
• Longterm health care utilization of SARS-CoV-2 infected individuals recruited from the general population [Time frame: Preliminary results in 03/2021]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 3 centers

• University Hospital Wuerzburg — Würzburg
• University Hospital Schleswig-Holstein, Campus Kiel — Kiel
• University Hospital Charité Berlin — Berlin

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 Coh PMID 41852926
• 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, Tammi PMID 38871878
• Hartung 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 fa PMID 38333368
• 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 PMID 35904671
• 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 co PMID 35875815

Identifiers

NCT: NCT04679584 · COVIDOM-Protokoll_V01F_2020-10 · DRKS00023742

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗