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

ConditionCOVID-19
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Schleswig-Holstein

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

PCR-confirmed SARS-CoV-2 infection

living in one of the target areas

age at least 18 years

written informed consent

Disqualifiers

Acute SARS-CoV-2 infection or reinfection

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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

Treatment groups

2,000 Participants
are divided into 3 treatment groups
Group A: Populationbased Platform (POP) of the National Pandemic Cohort Network (NAPKON)1 intervention
Group B: High-Resolution Platform (HAP) of the National Pandemic Cohort Network (NAPKON)1 intervention
Group C: Intersectoral Platform (SUEP) of the National Pandemic Cohort Network (NAPKON)1 intervention

Trial outcomes

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)

Time frame
Preliminary results in 03/2021

Secondary outcomes

1

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

Time frame
Preliminary results in 03/2021
2

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

Time frame
Preliminary results in 03/2021

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Schleswig-Holstein

Lead sponsor

Charite University, Berlin, Germany

Collaborator

Wuerzburg University Hospital

Collaborator

German Federal Ministry of Education and Research

Collaborator