Trial document




drksid header

  DRKS00023742

Trial Description

start of 1:1-Block title

Title

COVIDOM: Longterm morbidity of SARS-CoV-2 infection and COVID-19 disease – consequences for health status and quality of life

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

NAPKON - POP (National Pandemic Cohort Network - Population Based Platform)

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.covidom.de

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

Please see: www.napkon.de

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00023742
  •   2020/12/10
  •   [---]*
  •   yes
  •   Approved
  •   D 537/20, Ethikkommission der Christian-Albrechts-Universität zu Kiel
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   COVID19
  •   SARS-CoV-2 infection
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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.
  •   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.
  •   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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prognosis
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Longterm morbidities and sequels of SARS-CoV-2 infections in the general population 6 and 18 months after infection

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

(1) Reduced Quality of Life and Health Status
(2) Increased healthcare utilization

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/11/16
  •   2000
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Acute SARS-CoV-2 infection or reinfection

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Forschungsnetzwerk der Universitätsmedizin zu COVID-19 (Netzwerk Universitätsmedizin, NUM), Koordinierungsstelle Charité Berlin
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Nationales Pandemie Kohorten Netz
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Medizinische Klinik I, UKSH Campus Kiel
    • Mr.  Prof. Dr.  Stefan  Schreiber 
    • Arnold-Heller-Strasse 3
    • 24105  Kiel
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institut für Epidemiologie, UKSH Kiel
    • Ms.  Dr.  Anne  Hermes 
    • Niemannsweg 11
    • 24105  Kiel
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Forschungsnetzwerk der Universitätsmedizin zu COVID-19 (Netzwerk Universitätsmedizin, NUM), Koordinierungsstelle Berlin, Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.