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 volunteersQualifiers
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
Cohort
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 interventionOberservatory 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
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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
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
Sponsors and contacts
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University Hospital Schleswig-Holstein
Lead sponsor
Charite University, Berlin, Germany
Collaborator
Wuerzburg University Hospital
Collaborator
German Federal Ministry of Education and Research
Collaborator