Post-acute COVID-19 Sequelae in Denmark

NCT06191302 | Recruiting

• 1 other identifier: H-24039578
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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-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

Conditions

Non-communicable Disease; COVID-19

Keywords

Sequelae; Inflammation; Ageing; Non-communicable disease

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  Follow-up from index-admission to March 1, 2026

Other Outcomes (2)

• 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?

  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?

  Follow-up from index-admission to March 1, 2026

Study Arms (2)

SARS-CoV-2 positive patients

a cohort of former patients hospitalized with COVID-19

Procedure: blood sample; Other: Online questionaire

SARS-CoV-2 negative patients

a control group of former patients hospitalized with other respiratory diseases

Procedure: blood sample; Other: Online questionaire

Interventions

blood sample PROCEDURE

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.

SARS-CoV-2 negative patients; SARS-CoV-2 positive patients

Online questionaire OTHER

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.

SARS-CoV-2 negative patients; SARS-CoV-2 positive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The participating patients are former patients admitted to Hvidovre Hospital with the diagnosis OBS-COVID

You may qualify if:

• Has a blood sample in the clinical biobank related to the OBS-COVID index admission
• Aged above 18 years at time of index-admission

You may not qualify if:

• Patients without a Danish personal identification number
• Patients who do not understand or speak Danish

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Copenhagen University Hospital, Amager and Hvidovre

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Noncommunicable Diseases; COVID-19; Inflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ove Andersen, Professor

  Department of Clinical Research, Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

• Jon Ambaek Durhuus, PhD

  Department of Clinical Research, Copenhagen University Hospital, Hvidovre

  STUDY CHAIR

Central Study Contacts

Ove Andersen, Professor

CONTACT

+4529333262; ove.andersen@regionh.dk

Mette Bendtz Lindstroem, MPH

CONTACT

+4538623308; mlin0062@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director, professor,

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 5, 2024
• Study Start: September 10, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

DK (1)