Non-communicable DiseaseNCT06191302
Post-acute COVID-19 Sequelae in Denmark
An observational study of Non-communicable Disease and COVID-19, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-communicable Disease, COVID-19
- What is being tested?
- blood sample and Online questionaire
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Sep 2024to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participating patients are former patients admitted to Hvidovre Hospital with the diagnosis OBS-COVID
Who may be able to join
- Has a blood sample in the clinical biobank related to the OBS-COVID index admission
- Aged above 18 years at time of index-admission
Who cannot join
- Patients without a Danish personal identification number
- Patients who do not understand or speak Danish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital, Amager and Hvidovre
Hvidovre, 2650
Ove Andersen, Professor, +4529333262, ove.andersen@regionh.dk
Mette Lindstroem, MPH, +4538623308, mlin0062@regionh.dk
About this study
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, 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
Read the 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.
- Conditions
- Non-communicable Disease, COVID-19
- Being tested
- blood sample, Online questionaire
- Keywords
- Sequelae, Inflammation, Ageing, Non-communicable disease
- Medical subject headings
- Noncommunicable Diseases, COVID-19, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleProcedure or surgery
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 questionaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 positive patients | a cohort of former patients hospitalized with COVID-19 Receives: Procedure: blood sample; Other: Online questionaire | |
| SARS-CoV-2 negative patients | a control group of former patients hospitalized with other respiratory diseases Receives: Procedure: blood sample; Other: Online questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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:
- 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.
Measured: Follow-up from index-admission to March 1, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start10 Sep 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-communicable DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ove Andersen, Hvidovre University Hospital
- Investigators
- Ove Andersen, Professor, Principal investigator, Department of Clinical Research, Copenhagen University Hospital, HvidovreJon Ambaek Durhuus, PhD, Study chair, Department of Clinical Research, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191302
- Sponsor's protocol ID
- H-24039578
- Status last verified
- Mar 2025
- First submitted
- 2 Jan 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only aggregated data can be available for other researchers due to Danish Data Protection Law
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06191302
- Acronym / sponsor ID
- H-24039578
- Conditions
- Non-communicable Disease, COVID-19
- Keywords
- Sequelae, Inflammation, Ageing, Non-communicable disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 positive patients | – | Procedure: blood sample, Other: Online questionairea cohort of former patients hospitalized with COVID-19 |
| SARS-CoV-2 negative patients | – | Procedure: blood sample, Other: Online questionairea control group of former patients hospitalized with other respiratory diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participating patients are former patients admitted to Hvidovre Hospital with the diagnosis OBS-COVID
Key inclusion criteria (2 listed)
- Has a blood sample in the clinical biobank related to the OBS-COVID index admission
- Aged above 18 years at time of index-admission
Key exclusion criteria (2 listed)
- Patients without a Danish personal identification number
- Patients who do not understand or speak Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleBlood 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. | Procedure or surgery | SARS-CoV-2 negative patients, SARS-CoV-2 positive patients |
| Online questionaireThe 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. | Other | SARS-CoV-2 negative patients, SARS-CoV-2 positive patients |
Primary outcome
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. 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. 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Undecided. Only aggregated data can be available for other researchers due to Danish Data Protection Law
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ove Andersen, Professor principal investigator
Department of Clinical Research, Copenhagen University Hospital, Hvidovre
Jon Ambaek Durhuus, PhD study chair
Department of Clinical Research, Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-communicable Disease and COVID-19, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ove Andersen, Professor (+4529333262, ove.andersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.