Post-acute COVID-19 Sequelae in Denmark

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

Status Not yet recruiting

Clinical 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). 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

Clinical Trial 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. 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. ;

Related Conditions & MeSH terms

• COVID-19
• Non-communicable Disease
• Noncommunicable Diseases

• NCT number: NCT06191302
• Study type: Observational [Patient Registry]
• Source: Hvidovre University Hospital
• Contact: Ove Andersen, Professor
• Phone: +4529333262
• Email: ove.andersen@regionh.dk
• Status: Not yet recruiting
• Start date: February 1, 2024
• Completion date: March 1, 2026