COVID-19 Clinical Trial
Official 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
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's 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
Status | Not yet recruiting |
Enrollment | 800 |
Est. completion date | March 1, 2026 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 - Terminal patients - Patients who do not understand or speak Danish |
Country | Name | City | State |
---|---|---|---|
Denmark | Copenhagen University Hospital, Amager and Hvidovre | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1.1: Research question: Do pre-existing chronic conditions (e.g., chronic obstructive pulmonary disease (COPD), diabetes, and ischemic heart disease) affect the incidence and progression of new NCD and progression of pre-existing NCD in the PAP? | Assess the association between SARS-CoV-2 infection and incidence or exacerbation of NCD, by determining differences in the incidence of comorbidities (e.g., COPD, diabetes, and ischemic heart disease) and in the incidence and severity of NCD (e.g., pulmonary, cardiovascular, and renal disease) among SARS-CoV-2 infected and not infected individuals. | Follow-up from index-admission to March 1, 2026 | |
Primary | 1.2 Research question: Do the different SARS-CoV-2 strains affect the incidence and progression of new NCD and progression of pre-existing NCD in the PAP? | Determine the relationship between strains and incidence or exacerbation of NCD (e.g., pulmonary, cardiovascular, and renal disease). | Follow-up from index-admission to March 1, 2026 | |
Primary | 1.3 Research question: Do sex and/or SES affect the incidence or exacerbation of NCD after SARS-CoV-2 infection? | Examine associations of SES and sex with NCD incidence/severity, using SES indicators such as income, education, occupation, employment, ethnicity, public benefits and NCD incidence/severity indicators | Follow-up from index-admission to March 1, 2026 | |
Primary | 2.1 Research question: Are there differences in the distribution of biomarkers and clinical characteristics at admission between SARS-CoV-2 positive patients and patients admitted with other respiratory diseases and other respiratory symptoms? | Examine the association and difference in biomarker levels (e.g., inflammatory markers, cytokines, organ- and disease-specific markers) and clinical characteristics in COVID-19-positive patients compared to COVID-19-negative patients. | First 6-hours of index-hospitalization | |
Primary | 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 patients admitted with other respiratory disease/symptoms? | Assess the association between measured biomarkers and the occurrence, severity, or types of NCD (e.g., pulmonary, cardiovascular, and renal disease) | Follow-up from index-admission to March 1, 2026 | |
Primary | 2.3 Research question: Does SARS-CoV-2 infection modify the in-hospital disease progression of pre-existing conditions (e.g., COPD, diabetes, and ischemic heart diseases)? | Medicine, interventions, and biomarkers related to acute disease progression as well as standard blood biomarkers (e.g., soluble urokinase plasminogen activator receptor (suPAR), lactate dehydrogenase, leukocytes, albumin, C-reactive protein (CRP), blood urea nitrogen, glomerular filtration rate) | Follow-up from admission to discharge at index-hospitalization | |
Primary | 3.1 Research question: Is there a difference in the prevalence and symptom burden of NCD in the PAP between SARS-CoV-2 -positive patients and patients admitted with other respiratory diseases and other respiratory symptoms? | Assess and analyse patient-reported outcomes (e.g., perceived symptom severity, quality of life, and functional impairment) | Follow-up from index-admission to March 1, 2026 | |
Primary | 3.2 Research question: Is the association between pre-existing conditions and NCD-related outcomes modified by the post-acute SARS-CoV-2 status? | Examine if pre-existing conditions predispose post-acute COVID-19 individuals to increased/exacerbated NCD by delineate associations. | Follow-up from index-admission to March 1, 2026 | |
Primary | 4.1 Research question: Can cell-free plasma or serum from individuals with post-acute COVID-19 and NCD affect the fitness of a cell culture, and which circulating biomarkers are involved? | In cell culture, examine cellular fitness (e.g., morphology, bioenergetics (metabolism), stress response, fibrosis, viability/proliferation, senescence, and inflammation). | Feb 1, 2024 to Jan 31, 2028 | |
Primary | 4.2 Research question: Can circulating biomarkers found in 4.1 be used to describe the risk or progression of NCD? | Identify biomarkers and investigate biomarker-NCD associations | Feb 1, 2024 to Jan 31, 2028 | |
Secondary | 1.1: Research question: Do pre-existing chronic conditions (e.g., chronic obstructive pulmonary disease (COPD), diabetes, and ischemic heart disease) affect the incidence and progression of new NCD and progression of pre-existing NCD in the PAP? | Length of hospitalization (LOS), all-cause mortality, severity of COVID-19 symptoms in individuals with comorbidities, COVID-19 complications (e.g., pneumonia) in individuals with comorbidities, vaccine effectiveness, after-COVID-19 symptoms and quality of life, and severity grading of NCD. | Follow-up from index-admission to March 1, 2026 | |
Secondary | 1.2 Do the different SARS-CoV-2 strains affect the incidence and progression of new NCD and progression of pre-existing NCD in the PAP? | Distribution of SARS-CoV-2 types. Determine differences in the LOS, mortality rate, complications, interventions, pharmacological treatment, and vaccine effectiveness in groups infected with different strains. | Follow-up from index-admission to March 1, 2026 | |
Secondary | 1.3 Research question: Do sex and/or SES affect the incidence or exacerbation of NCD after SARS-CoV-2 infection? | LOS, all-cause mortality, severity of COVID-19 symptoms in individuals with comorbidities, COVID-19 complications, vaccination status, and sick leave. | Follow-up from index-admission to March 1, 2026 | |
Secondary | 2.1 Research question: Are there differences in the distribution of biomarkers and clinical characteristics at admission between SARS-CoV-2 positive patients and patients admitted with other respiratory diseases and other respiratory symptoms? | All-cause mortality, LOS, inpatient disease progression (e.g., ICU, invasive mechanical ventilation, treatment response, and biomarker dynamics/profiles). | First 6-hours of index-hospitalization | |
Secondary | 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 patients admitted with other respiratory disease/symptoms? | Predictive values of measured biomarkers and biomarker patterns compared to LOS, risk of inpatient disease progression, after-COVID symptoms, and quality of life. | Follow-up from index-admission to March 1, 2026 | |
Secondary | 2.3 Research question: Does SARS-CoV-2 infection modify the in-hospital disease progression of pre-existing conditions (e.g., COPD, diabetes, and ischemic heart diseases)? | Hospital admission, risk of inpatient disease progression. | Follow-up from admission to discharge at index-hospitalization | |
Secondary | 3.1 Research question: Is there a difference in the prevalence and symptom burden of NCD in the PAP between SARS-CoV-2 -positive patients and patients admitted with other respiratory diseases and other respiratory symptoms? | Medicines, interventions, biomarkers related to biological ageing, acute disease progression as well as standard blood biomarkers (e.g., suPAR, lactate dehydrogenase, leukocytes, albumin, CRP, blood urea nitrogen, glomerular filtration rate) | Follow-up from index-admission to March 1, 2026 | |
Secondary | 3.2 Research question: Is the association between pre-existing conditions and NCD-related outcomes modified by the post-acute SARS-CoV-2 status? | Type of NCD, impact of pre-existing conditions on NCD recovery, mortality, and treatment response. | Follow-up from index-admission to March 1, 2026 | |
Secondary | 4.2 Research question: Can circulating biomarkers found in 4.1 be used to describe the risk or progression of NCD? | Virtual modelling of post infection NCD related to pulmonary, renal, and cardiovascular tissues. | Feb 1, 2024 to Jan 31, 2028 |
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