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NCT Number: NCT06191302

Post-acute COVID-19 Sequelae in Denmark

Since the first SARS-CoV-2 cases in 2019, over 660 million COVID-19 cases have been reported globally, including 183 million in the EU. Up to 70% of those infected experience reduced organ function four months or more after a COVID-19 diagnosis, potentially increasing the risk of non-communicable diseases (NCDs). The post-acute phase (PAP) after COVID-19 (four months or more after the acute phase) can lead to impaired function in various organ systems, with a focus on the lungs, cardiovascular system, and kidneys. These three NCDs collectively impose a significant burden on individuals and society. Urgently, we need to understand the connection between COVID-19, PAP and NCDs, identifying robust biomarkers for early detection. This study examines PAP and associated risk factors, investigating the link between PAP and the heightened risk of lung, heart, and kidney complications. Utilizing data from a cohort of COVID-19 patients and a control group with respiratory diseases, the study aims to determine prevalence and risk ratios more precisely. The aim is to contribute to minimizing the risk of NCD development or exacerbation in current and future COVID-19 patients, enhancing our understanding of chronic disease development at the population leve

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital, Amager and Hvidovre

Hvidovre, 2650, Denmark

Location status: Recruiting

Location contact

Mette Lindstroem, MPH

CONTACT

[email protected]

+4538623308

Ove Andersen, Professor

CONTACT

[email protected]

+4529333262

Ove Andersen, Professor

PRINCIPAL_INVESTIGATOR

About this study

The post-acute phase (PAP) after COVID-19 (four months or more after the acute phase of COVID-19) can manifest with reduced function in multiple organ systems, with a particular focus on the lungs, cardiovascular system, and kidneys. Collectively, these three non-communicable diseases (NCDs) represent a significant burden for both the individual and society as a whole. There is an urgent need to elucidate this connection and build a more detailed understanding of the link between COVID-19's PAP and individual NCDs, as well as to identify robust biomarkers that can assist in the early identification of the development of these NCDs.

This study focuses on PAP and the associated risk factors in this later phase of the disease, examining the relationship between PAP and the increased risk of specifically lung, heart, and kidney complications in the Danish population. Additionally, data (medical records, registry data, patient reported outcomes and blood samples) from a cohort of former patients hospitalized with COVID-19, as well as a control group hospitalized with other respiratory diseases, are investigated to determine the prevalence and risk ratios in disease development more precisely.

The purpose of the study is to contribute to minimizing the risk of developing or worsening NCDs in current and future COVID-19 patients, as well as contributing to our understanding of chronic disease development at the population level. The study aims to investigate the hypothesis that biomarkers can predict if SARS-CoV-2 infection leads to increased and exacerbated non-communicable pulmonary, cardiovascular, and renal diseases.

Further, we address the unmet need to understand the molecular mechanisms responsible for the link between post-acute effects of SARS-CoV-2 and complications in the pulmonary, cardiovascular, and renal system. More specific we will investigate the molecular mechanisms responsible for the aetiology and decline in organ function.

The population in the registry study is the entire population of Denmark. The population in the clinical cohort consists of former patients who have been admitted to Hvidovre Hospital with the diagnosis OBS COVID. Participants consent to the use of residual material from their blood sample, taken during their hospitalization with the diagnosis OBS-COVID in the period 2020-2022 (index blood sample). After obtaining consent, patients come to Hvidovre Hospital, where a blood sample (follow-up blood sample) is taken, and an online questionnaire is completed and stored in REDCap. Blood samples are analyzed and compared with collected registry data and questionnaire data, after which the results are reported in international peer-reviewed journals.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Has a blood sample in the clinical biobank related to the OBS-COVID index admission
  • Aged above 18 years at time of index-admission

Exclusion criteria

  • Patients without a Danish personal identification number
  • Patients who do not understand or speak Danish

Treatment and study plan

Blood sample

Procedure

Blood sample collected in the post-acute period (follow-up visit) will be analysed for biomarkers predictive for diseases related to and disease progression in various organ systems (e.g., cardiovascular, pulmonary, and renal systems), including e.g., Pro-BNP, NGAL, and interleukins.

online questionaire

Other

The participants will complete an online questionnaire related to disease and health issues associated with COVID-19 and COVID-19 post-acute sequalae's and existing Non-Communicable Disease.

Primary outcomes

  1. 1.Is there a difference in the incidence and disease progression of NCD (pulmonary, cardiovascular, and renal disease) in the PAP between SARS-CoV-2-positive patients and a control group of patients admitted with other respiratory diseases?

    Time frame: Follow-up from index-admission to March 1, 2026

    Primary outcomes:

    • Incidence of incipient NCD
    • Change in health-state of pre-existing NCD
  2. 2. Is there a difference in the association of admission biomarkers and incidence, severity, and disease progression of NCD in PAP, between SARS-CoV-2 positive patients and a control group of patients admitted with other respiratory diseases?

    Time frame: Follow-up from index-admission to March 1, 2026

    • Level in admission biomarkers associated with incipient or worsening of NCD in PAP
  3. 3. Which biomarkers are involved in development or disease progression of NCDs in PAP?

    Time frame: Follow-up from index-admission to March 1, 2026

    Principal outcomes:

    • Identify in vivo biomarkers in admission and follow-up blood samples associated with tissue /organ damage, and inflammation
    • Investigate in vitro molecular mechanisms in follow-up blood samples by examining cellular morphology, metabolism, stress response, fibrosis, viability, proliferation, senescence, and inflammation.

Other outcomes

  1. 1.Is there a difference in the incidence and disease progression of NCD (pulmonary, cardiovascular, and renal disease) in the PAP between SARS-CoV-2-positive patients and a control group of patients admitted with other respiratory diseases?

    Time frame: Follow-up from index-admission to March 1, 2026

    Other outcomes:

    • Incidence of incipient NCD stratified by the socioeconomic position of patients
    • Change in health-state of pre-existing NCD stratified by the socioeconomic position of patients
  2. 2. Is there a difference in the association of admission biomarkers and incidence, severity, and disease progression of NCD in PAP, between SARS-CoV-2 positive patients and a control group of patients admitted with other respiratory diseases?

    Time frame: Follow-up from index-admission to March 1, 2026

    • Level in admission biomarkers associated with symptoms, lower quality of life, functional impairment in PAP.

Study contacts

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

Mette Bendtz Lindstroem, MPH

CONTACT

[email protected]

+4538623308

Ove Andersen, Professor

CONTACT

[email protected]

+4529333262

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Investigation of COVID-19 Post-acute Sequelae in Patients From Hvidovre Hospitals Catchment Area, and in a Register of the Danish Population 2000-2026

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2024
Registry last updated
Mar 12, 2025

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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