Post-acute COVID-19 Sequelae in Denmark
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHvidovre University Hospital
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Has a blood sample in the clinical biobank related to the OBS-COVID index admission
Aged above 18 years at time of index-admission
Disqualifiers
Patients without a Danish personal identification number
Patients who do not understand or speak Danish
Trial population
The participating patients are former patients admitted to Hvidovre Hospital with the diagnosis OBS-COVID
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
blood sample
Procedure/SurgeryBlood 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 interventionThe 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.
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: SARS-CoV-2 positive patients2 interventions
Group B: SARS-CoV-2 negative patients2 interventions
Trial outcomes
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?
Primary outcomes: * Incidence of incipient NCD * Change in health-state of pre-existing NCD
Time frame
Follow-up from index-admission to March 1, 20262
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
Time frame
Follow-up from index-admission to March 1, 20263
3. Which biomarkers are involved in development or disease progression of NCDs in PAP?
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.
Time frame
Follow-up from index-admission to March 1, 2026Other 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?
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
Time frame
Follow-up from index-admission to March 1, 20262
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.
Time frame
Follow-up from index-admission to March 1, 2026Sponsors and contacts
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Source ClinicalTrials.gov