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NCT04679584: NAPKON-POP

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

Recruiting now Last updated 22 December 2020
What this trial tests

trial testing Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings in COVID-19 in 2,000 participants. Currently enrolling.

Timeline
16 November 2020
Primary endpoint
31 December 2021
31 December 2030

Quick facts

Lead sponsorUniversity Hospital Schleswig-Holstein
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment2,000
Start date16 November 2020
Primary completion31 December 2021
Estimated completion31 December 2030
Sites3 locations across Germany

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital Schleswig-Holstein

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Post-acute COVID-19 syndrome.
    Nalbandian A, Sehgal K, Gupta A, Madhavan MV, et al · · 2021 · cited 3355× · PMID 33753937 · DOI 10.1038/s41591-021-01283-z
  2. Severity, predictors and clinical correlates of Post-COVID syndrome (PCS) in Germany: A prospective, multi-centre, population-based cohort study.
    Bahmer T, Borzikowsky C, Lieb W, Horn A, et al · · 2022 · cited 129× · PMID 35875815 · DOI 10.1016/j.eclinm.2022.101549
  3. Fatigue and cognitive impairment after COVID-19: A prospective multicentre study.
    Hartung TJ, Neumann C, Bahmer T, Chaplinskaya-Sobol I, et al · · 2022 · cited 120× · PMID 36133318 · DOI 10.1016/j.eclinm.2022.101651
  4. The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics.
    Schons M, Pilgram L, Reese JP, Stecher M, et al · · 2022 · cited 44× · PMID 35904671 · DOI 10.1007/s10654-022-00896-z
  5. Predictors of non-recovery from fatigue and cognitive deficits after COVID-19: a prospective, longitudinal, population-based study.
    Hartung TJ, Bahmer T, Chaplinskaya-Sobol I, Deckert J, et al · · 2024 · cited 40× · PMID 38333368 · DOI 10.1016/j.eclinm.2024.102456
  6. Long-term health sequelae and quality of life at least 6 months after infection with SARS-CoV-2: design and rationale of the COVIDOM-study as part of the NAPKON population-based cohort platform (POP).
    Horn A, Krist L, Lieb W, Montellano FA, et al · · 2021 · cited 32× · PMID 34642875 · DOI 10.1007/s15010-021-01707-5
  7. Persistent symptoms and risk factors predicting prolonged time to symptom-free after SARS‑CoV‑2 infection: an analysis of the baseline examination of the German COVIDOM/NAPKON-POP cohort.
    Shi Y, Strobl R, Apfelbacher C, Bahmer T, et al · · 2023 · cited 10× · PMID 37231313 · DOI 10.1007/s15010-023-02043-6
  8. Subdomains of Post-COVID Syndrome (PCS) - a population-based study.
    Ballhausen-Lübcker S, Ruß AK, Lieb W, Schäfer A, et al · · 2025 · cited 3× · PMID 40859262 · DOI 10.1186/s12879-025-11368-6

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