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RECRUITING
NCT06608849

The Incidence of Pulmonary, Cardiovascular and Renal System Non-communicable Complications Associated With the Post-acute Phase of the Infection by Covid-19

Sponsor: Hellenic Institute for the Study of Sepsis

View on ClinicalTrials.gov

Summary

More than 660 million cases of COVID-19 have been reported worldwide, with 183 million cases in the EU alone. In several people, after recovery, the effects of the first waves of COVID-19 persisted beyond the acute phase and increased the risk of chronic multiorgan symptoms and disease. Up to 70% of people affected by COVID-19 showed reduced organ function even four months or more after COVID-19 diagnosis. Such a functional decline is associated with an increased risk of the development of non-communicable diseases (NCDs). Thus, there is an essential need for a better knowledge, tools, clinical guidelines and recommendations that it will make it possible to reduce this overrepresentation of NCDs as a consequence of the post-acute phase (PAP) of COVID-19. The overall concept underpinning "POINT" is to i) build detailed knowledge on the link between the PAP of COVID-19 caused by previous, current, and future SARS-CoV-2 variants in vaccinated and unvaccinated people, and NCDs, ii) identify robust biomarkers and build predictive tools that help early identification and management of risk of NCDs, and iii) develop guidelines and recommendations for all parts of the healthcare value chain, allowing best prevention and care acknowledging vulnerability. The investigators will focus on the NCDs affecting pulmonary, cardiovascular and renal systems.

Official title: A Non-interventional, Prospective, Cross-sectional Study of the Incidence of Pulmonary, Cardiovascular and Renal System Non-communicable Complications Associated With the Post-acute Phase of the Infection by Sars-Cov-2

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

345

Start Date

2024-12-10

Completion Date

2027-11-04

Last Updated

2025-11-17

Healthy Volunteers

Yes

Interventions

OTHER

Blood samples

Blood sampling for proteomics and transcriptomics, suPAR measurement \& isolation and stimulation of peripheral blood mononuclear cells, eGFR, serum creatinine, cystatin c \& urea

OTHER

Six-minute walk test, Spirometry, HRCT, Heart ultrasound, Completion of questionnaires of symptoms

Spirometry for forced expiratory volume in the first, second, total lung capacity and diffusion capacity of carbon monoxide.

Locations (6)

10th Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases

Athens, Greece

4th Department of Internal Medicine, ATTIKON University General Hospital

Athens, Greece

Obstructive Diseases Clinic, Sotiria Athens Hospital of Chest Diseases

Athens, Greece

Out-patient department of Infectious Diseases, Sotiria Athens Hospital of Chest Diseases

Athens, Greece

1st Department of Internal Medicine, Thriasio General Hospital of Elefsina

Elefsina, Greece

2nd Department of Internal Medicine, Thriasio General Hospital of Elefsina

Elefsina, Greece