Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.

NCT06601998 | Recruiting

• 1 other identifier: HOMI-LUNG CAP
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 17

Brief Summary

Pneumonia, which can be acquired in the community (including influenza and COVID-19), is a leading cause of mortality. The risk of severe cardiovascular diseases events (stroke, myocardial infarction, pulmonary embolism) increases after infections, but causal mechanisms are not understood yet. There is an essential need for improved understanding of the relationship between pneumonia and cardiovascular diseases and early identification of patients at risk of cardiovascular events to develop tailored therapies. The overall concept underpinning "Homi-lung" is to investigate the time course of host-microbiome interactions during \& after pneumonia to i) understand the causal relationship between trained immunity, microbiome dysbiosis and cardiovascular and respiratory diseases (CVRD) progressions, ii) define endotypes of pneumonia associated with response to treatment \& CVRD history; iii) develop biomarkers to predict the individual response to the treatment \& CVRD progression, and iv) preclinically validate therapeutical approaches for CVRD during \& after pneumonia.

Conditions

Pneumonia, Community-Acquired; COVID-19 Pneumonia; Cardiovascular Diseases

Keywords

Covid-19; SARS-CoV-2; Lung infection; Cardiovascular disease; Respiratory disease; Endotypes; Biomarkers; Cardiorespiratory; Economic cost

Outcome Measures

Primary Outcomes (2)

• The first primary outcome is the rates of major cardiovascular disease event at 6 months.

  Major CVD events are all-cause mortality, stroke, non-fatal acute coronary syndrome, pulmonary embolism or venous thrombosis

  From enrollment to Month 6.

• The second primary endpoint is poor cardiorespiratory fitness at 36 months.

  Poor fitness is a VO2max lower than normal values for age.

  From enrollment to Month 36.

Secondary Outcomes (14)

• Rates of unplanned hospitalisation

  From enrollment to Month 36.

• Rates of COPD exacerbation, hospitalization for respiratory failure and/or respiratory-related mortality at 3 years

  From enrollment to Month 36.

• Rates of secondary episodes of pneumonia, the incidence of non-respiratory infections

  From enrollment to Month 36.

• The rates of major cardiovascular disease event and of poor cardiorespiratory fitness

  At 6 and 36 months

• The rates of major cardiovascular disease event and of poor cardiorespiratory fitness

  At 6 and 36 months

Study Arms (4)

Healthy controls

Controls with no or one comorbidity, predisposing to significant CV events and without a medical history of severe pneumonia.

Other: Blood samples and Oropharyngeal swab

CVRD controls

Controls with comorbidities predisposing to major CV events and without a medical history of severe pneumonia

Other: Blood samples and Oropharyngeal swab; Other: Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptoms

COVID-19 survivors

Patients cured of acute COVID-19

Other: Blood samples and Oropharyngeal swab; Other: Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptoms

sCAP survivors

Patients cured of severe community-acquired pneumonia

Other: Blood samples and Oropharyngeal swab; Other: Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptoms

Interventions

Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptoms OTHER

* Spirometry for forced expiratory volume in the first, second, total lung capacity and diffusion capacity of carbon monoxide. * ECG, Heart ultrasound and cardiopulmonary exercise stress testing: * NYHA * Rhythm or conduction abnormality (yes/no) * Left ventricular ejection fraction (%) * VO2Max

COVID-19 survivors; CVRD controls; sCAP survivors

Blood samples and Oropharyngeal swab OTHER

Blood samples: EDTA-plasma (proteome, metabolome and lipidome) and PBMCs (transcriptome, epigenome, immune-phenotype and genetic polymorphism)

COVID-19 survivors; CVRD controls; Healthy controls; sCAP survivors

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 study needs to enroll four groups of patients to cover the magnitude of the spectrum of community-acquired pneumonia and enroll the required controls: * Group A: Controls with no or one comorbidity, predisposing to significant CV events and without a medical history of severe pneumonia. This group is important to provide baseline biological values and control samples to investigate normal host-microbiome interactions. No follow-up is performed for healthy controls. * Group B: Controls with comorbidities predisposing to major CV events and without a medical history of severe pneumonia. This group is important to provide normal CVRD progression in patients at risk and control samples for the investigation of host-microbiome interactions in patients with stable CVRD. * Group C: Patients cured of acute COVID-19. * Group D: Patients cured of severe community-acquired pneumonia.

You may qualify if:

• Group A (healthy controls)
• Adults (18 years or more) of both genders (Female/Male: 50/50 ratio)
• No history of severe pneumonia (sCAP, COVID-19 or HAP)
• Presence of no or one of the following comorbidities: obesity (defined as body mass index over 35 kg/m2), type 2 diabetes mellitus, hypercholesterolemia, essential arterial hypertension, or familial history of CVD.
• Group B (CVRD controls)
• Adults (18 years or more) of both genders (Female/Male ratio: 50/50)
• No history of severe pneumonia (sCAP, COVID-19 or HAP)
• At least two of the following comorbidities: obesity (defined as body mass index over 35 kg/m2), type 2 diabetes mellitus, hypercholesterolemia, essential arterial hypertension, or familial history of CVD
• Group C (COVID-19 survivors)
• Adults (18 years or more) of both genders (Female/Male ratio: 50/50)
• Survivors from severe COVID-19 pneumonia at hospital discharge; all patients had consolidation in chest X-ray or chest computed tomography during acute infection and were treated for pneumonia
• SoC treatment for acute COVID-19 with dexamethasone
• Group D (sCAP survivors)
• Adults (18 years or more) of both genders
• Survivors from sCAP pneumonia; these patients may be either hospitalized in the ward with pO2FiO2 ratio less than 300 or require admission and hospitalization in the Intensive Care Unit.

You may not qualify if:

• Group A (healthy controls)
• Presence of two or more comorbidities
• Any other co-existing disorder generating CVRD symptoms
• 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
• Group B (CVRD controls)
• Any other co-existing disorder generating CVRD symptoms
• 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
• Group C (COVID-19 survivors)
• Medical history of severe congestive heart failure (Stage III-IV)
• Medical history of stage 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
• Group D (sCAP survivors)

Sponsors & Collaborators

• Hellenic Institute for the Study of Sepsis: lead

Study Sites (17)

2nd Department of Internal Medicine, University General Hospital of Alexandroupolis

Alexandroupoli, Greece

NOT YET RECRUITING

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

Athens, Greece

RECRUITING

1st Department of Internal Medicine, General Hospital of Athens G. GENNIMATAS

Athens, Greece

RECRUITING

1st Department of Internal Medicine, General Hospital of Athens KORGIALENIO-BENAKIO E.E.S.

Athens, Greece

RECRUITING

1st Department of Internal Medicine, General Hospital of Voula ASKLEPIEIO

Athens, Greece

RECRUITING

1st Intensive Care Clinic of the Medical School of the University of Athens, Evangelismos General Hospital

Athens, Greece

RECRUITING

1st University Department of Internal Medicine, General Hospital of Athens LAIKO

Athens, Greece

RECRUITING

1st University Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases

Athens, Greece

RECRUITING

2nd Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases

Athens, Greece

RECRUITING

3rd University Department of Internal Medicine, Sotiria Athens Hospital of Chest Diseases

Athens, Greece

RECRUITING

4th Department of Internal Medicine, ATTIKON University General Hospital

Athens, Greece

RECRUITING

Intensive Care Unit, General Hospital of Voula ASKLEPIEIO

Athens, Greece

RECRUITING

Out-patients clinic, General Hospital of Voula ASKLEPIEIO

Athens, Greece

RECRUITING

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

Elefsina, Greece

NOT YET RECRUITING

1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki

Thessaloniki, Greece

NOT YET RECRUITING

Intensive Care Unit 2, AHEPA University General Hospital of Thessaloniki

Thessaloniki, Greece

NOT YET RECRUITING

Intensive Care Unit, "Ippokrateion" General Hospital of Thessaloniki

Thessaloniki, Greece

NOT YET RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia; Cardiovascular Diseases; COVID-19; Respiration Disorders

Interventions

Blood Specimen Collection; epicatechin gallate

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

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 16, 2024
• First Posted: September 19, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): November 8, 2027
• Study Completion (Estimated): June 8, 2028
• Last Updated: February 17, 2026

Record last verified: 2025-11

Locations

GR (17)