Post-acute COVID-19 Sequelae in Denmark
- Conditions
- COVID-19Non-communicable Disease
- Interventions
- Procedure: blood sampleOther: Online questionaire
- Registration Number
- NCT06191302
- Lead Sponsor
- Hvidovre University Hospital
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Has a blood sample in the clinical biobank related to the OBS-COVID index admission
- Aged above 18 years at time of index-admission
- Patients without a Danish personal identification number
- Patients who do not understand or speak Danish
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SARS-CoV-2 positive patients Online questionaire a cohort of former patients hospitalized with COVID-19 SARS-CoV-2 negative patients blood sample a control group of former patients hospitalized with other respiratory diseases SARS-CoV-2 negative patients Online questionaire a control group of former patients hospitalized with other respiratory diseases SARS-CoV-2 positive patients blood sample a cohort of former patients hospitalized with COVID-19
- Primary Outcome Measures
Name Time Method 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? Follow-up from index-admission to March 1, 2026 Primary outcomes:
* Incidence of incipient NCD
* Change in health-state of pre-existing NCD2. 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? Follow-up from index-admission to March 1, 2026 • Level in admission biomarkers associated with incipient or worsening of NCD in PAP
3. Which biomarkers are involved in development or disease progression of NCDs in PAP? 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Copenhagen University Hospital, Amager and Hvidovre
🇩🇰Hvidovre, Denmark