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

NCT06608849 | Recruiting

• 1 other identifier: POINT
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Pulmonary Complications; Cardiovascular Complications; Renal Complications; COVID-19

Keywords

Covid-19; SARS-CoV-2; Pulmonary complications; Cardiovascular complications; Renal complications; Post-acute phase; Non communicable diseases; Biomarkers; Prevention

Outcome Measures

Primary Outcomes (1)

• The incidence of any organ dysfunction during the first 48 months among patients of group C compared to group B

  This is a composite endpoint which includes the development of chronic failures of at least one of lung, heart and/or kidneys

  From enrollment to Month 48

Secondary Outcomes (5)

• The incidence of any organ dysfunction during the first 48 months among patients of group C compared to group A.

  From enrollment to Month 48.

• The incidence of any organ dysfunction during the first 48 months among patients of group B compared to group A.

  From enrollment to Month 48.

• The incidence of chronic lung failure during the first 48 months among patients of group C compared to group B.

  From enrollment to Month 48.

• • The incidence of chronic heart failure during the first 48 months among patients of group C compared to group B.

  From enrollment to Month 48.

• • The incidence of chronic renal disease during the first 48 months among patients of group C compared to group B.

  From enrollment to Month 48.

Study Arms (3)

Comparators

Comparators without medical history of acute infection by SARS-CoV-2.

Other: Blood samples; Other: Six-minute walk test, Spirometry, HRCT, Heart ultrasound, Completion of questionnaires of symptoms

Participants with NO dysfunction

Patients fully recovered by acute COVID-19 who did not present any acute organ injury during acute infection by SARS-CoV-2.

Other: Blood samples; Other: Six-minute walk test, Spirometry, HRCT, Heart ultrasound, Completion of questionnaires of symptoms

Participants with Dysfunctions

Patients who presented signs of lung, heart, and kidney dysfunction during acute infection by SARS-CoV-2.

Other: Blood samples; Other: Six-minute walk test, Spirometry, HRCT, Heart ultrasound, Completion of questionnaires of symptoms

Interventions

Blood samples OTHER

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

Comparators; Participants with Dysfunctions; Participants with NO dysfunction

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

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

Comparators; Participants with Dysfunctions; Participants with NO dysfunction

Eligibility Criteria

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

Study Population

POINT will include patients who have participated in the studies ESCAPE, SAVE, SAVE-MORE and SAVE-LONG. For these patients blood samples and clinical data are already available (Baseline - Year 0 from ESCAPE, SAVE \& SAVE-MORE and Year 1 from SAVE-LONG). POINT needs to enroll three groups of patients (selected by the existing biobank mentioned above, based on the inclusion and exclusion study criteria) to cover the magnitude of the spectrum of COVID-19: * Group A (115 Comparators): Comparators without medical history of acute infection by SARS-CoV-2. * Group B (115 with NO dysfunction): Patients fully recovered by acute COVID-19 who did not present any acute organ injury during acute infection by SARS-CoV-2. * Group C (115 with Dysfunctions): Patients who presented signs of lung, heart, and kidney dysfunction during acute infection by SARS-CoV-2.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Institute for the Study of Sepsis: lead

Study Sites (6)

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

Athens, Greece

RECRUITING

4th Department of Internal Medicine, ATTIKON University General Hospital

Athens, Greece

RECRUITING

Obstructive Diseases Clinic, Sotiria Athens Hospital of Chest Diseases

Athens, Greece

RECRUITING

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

Athens, Greece

RECRUITING

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

Elefsina, Greece

RECRUITING

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

Elefsina, Greece

RECRUITING

MeSH Terms

Conditions

COVID-19; Noncommunicable Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Prof. Evangelos Giamarellos-Bourboulis

  Hellenic Institute for the Study of Sepsis

  STUDY CHAIR

Central Study Contacts

Prof. Evangelos Giamarellos-Bourboulis

CONTACT

00302105831994; egiamarel@med.uoa.gr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 23, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): November 4, 2027
• Study Completion (Estimated): November 4, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

GR (6)