RecruitingNCT06608849

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

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


Sponsor

Hellenic Institute for the Study of Sepsis

Enrollment

345 participants

Start Date

Dec 10, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria12

  • Group A (comparators)
  • Adults (18 years or more) of both genders
  • Negative history of acute COVID-19
  • Group B (patients with ΝΟ dysfunction)
  • Adults (18 years or more) of both genders
  • History of acute COVID-19 hospitalized or non-hospitalized. All cases appearing from start of the pandemic until the last six months may apply
  • Absence of any current overt organ dysfunction
  • Absence of signs of any organ dysfunction during acute COVID-19
  • Group C (patients with dysfunctions)
  • Adults (18 years or more) of both genders
  • History of acute COVID-19 hospitalized or non-hospitalized. All cases appearing from start of the pandemic until the last six months may apply
  • Presence of signs of organ dysfunction of the lung, the kidneys or the heart during acute COVID-19

Exclusion Criteria19

  • Group A (comparators)
  • Any other co-existing disorder generating clinical symptoms
  • Failure to thrive according to the attending physicians
  • Pregnancy or lactation
  • Group B (patients with ΝΟ dysfunction)
  • Any other co-existing disorder generating clinical symptoms
  • Failure to thrive according to the attending physicians
  • Pregnancy or lactation
  • Group C (patients with dysfunctions)
  • Any other co-existing disorder generating clinical symptoms
  • Medical history of any of:
  • stage III or IV chronic obstructive pulmonary disease according to the GOLD criteria
  • pulmonary fibrosis or pulmonary hypertension
  • stage IV solid tumour malignancy under chemotherapy or radiotherapy
  • systemic sclerosis
  • congestive heart failure
  • stage II, III or IV dyspnoea according to the New York Heart Association classification before the acute COVID-19
  • Limited chance of survival for at least six months due to co-existing comorbidity(-ies) according to the judgement of the attending physicians
  • Pregnancy or lactation

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Interventions

OTHERBlood samples

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

OTHERSix-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

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NCT06608849


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