Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06191302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2024-01-02
Brief Title:
Post-acute COVID-19 Sequelae in Denmark
Sponsor:
Hvidovre University Hospital
Organization:
Hvidovre University Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-19s 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-19s 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 We will identify molecular mechanisms for PAP after COVID-19 examining whether there are biomarkers that can be used for early risk assessment and provide information about disease progression Furthermore the project has the potential to contribute to the discovery of new drugs that can reduce the risk associated with PAP after COVID-19 as data from the project will be used in the construction of a trans-European simulation model for virtual drug testing virtual twin
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
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 We will identify molecular mechanisms for PAP after COVID-19 examining whether there are biomarkers that can be used for early risk assessment and provide information about disease progression Furthermore the project has the potential to contribute to the discovery of new drugs that can reduce the risk associated with PAP after COVID-19 as data from the project will be used in the construction of a trans-European simulation model for virtual drug testing virtual twin
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None