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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-CoV-2 positive patients | a cohort of former patients hospitalized with COVID-19 |
| |
| SARS-CoV-2 negative patients | a control group of former patients hospitalized with other respiratory diseases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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? | Primary outcomes:
| Follow-up from index-admission to March 1, 2026 |
| 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? | • Level in admission biomarkers associated with incipient or worsening of NCD in PAP | Follow-up from index-admission to March 1, 2026 |
| 3. Which biomarkers are involved in development or disease progression of NCDs in PAP? | Principal outcomes:
| Follow-up from index-admission to March 1, 2026 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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? | Other outcomes:
|
Inclusion Criteria:
Exclusion Criteria:
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The participating patients are former patients admitted to Hvidovre Hospital with the diagnosis OBS-COVID
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ove Andersen, Professor | Contact | +4529333262 | ove.andersen@regionh.dk | |
| Mette Bendtz Lindstroem, MPH | Contact | +4538623308 | mlin0062@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Ove Andersen, Professor | Department of Clinical Research, Copenhagen University Hospital, Hvidovre | Principal Investigator |
| Jon Ambaek Durhuus, PhD | Department of Clinical Research, Copenhagen University Hospital, Hvidovre |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Amager and Hvidovre | Recruiting | Hvidovre | 2650 | Denmark |
Only aggregated data can be available for other researchers due to Danish Data Protection Law
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| ID | Term |
|---|---|
| D000073296 | Noncommunicable Diseases |
| D000086382 | COVID-19 |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| 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. |
|
| Follow-up from index-admission to March 1, 2026 |
| 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? | • Level in admission biomarkers associated with symptoms, lower quality of life, functional impairment in PAP. | Follow-up from index-admission to March 1, 2026 |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |