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NCT Number: NCT04679584

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Wuerzburg, Würzburg, Bavaria, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings

Other

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 outcomes

  1. Longterm morbidities and sequels of SARS-CoV-2 infections in the general population

    Time frame: Preliminary results in 03/2021

    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)

Secondary outcomes

  1. Longterm quality of life of SARS-CoV-2 infected individuals recruited from the general population

    Time frame: Preliminary results in 03/2021

    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

  2. Longterm health care utilization of SARS-CoV-2 infected individuals recruited from the general population

    Time frame: Preliminary results in 03/2021

    Longitudinal assessment of health-care utilization based on insurance data in SARS-CoV-2 infected individuals of different severity grades

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan Schreiber, Prof. Dr.

CONTACT

[email protected]

0049 (0)431 500 22201

Thomas Bahmer, Prof. Dr.

CONTACT

[email protected]

0049 (0) 431 500 62629

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • Charite University, Berlin, Germany
  • German Federal Ministry of Education and Research
  • Wuerzburg University Hospital

Registry information

Official study title

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

Acronym: NAPKON-POP

Important dates

Study start
2020
Primary completion
2021
Study completion
2030
First posted
Dec 22, 2020
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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