NCT06601998 Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
| NCT ID | NCT06601998 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hellenic Institute for the Study of Sepsis |
| Condition | Pneumonia, Community-Acquired |
| Study Type | OBSERVATIONAL |
| Enrollment | 650 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2027-11-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 650 participants in total. It began in 2024-11-08 with a primary completion date of 2027-11-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: Group A (healthy controls) 1. Adults (18 years or more) of both genders (Female/Male: 50/50 ratio) 2. No history of severe pneumonia (sCAP, COVID-19 or HAP) 3. 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) 1. Adults (18 years or more) of both genders (Female/Male ratio: 50/50) 2. No history of severe pneumonia (sCAP, COVID-19 or HAP) 3. 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) 1. Adults (18 years or more) of both genders (Female/Male ratio: 50/50) 2. 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 3. SoC treatment for acute COVID-19 with dexamethasone Group D (sCAP survivors) 1. Adults (18 years or more) of both genders 2. 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. 3. SoC treatment for sCAP with antibiotics Exclusion Criteria: Group A (healthy controls) 1. Presence of two or more comorbidities 2. Any other co-existing disorder generating CVRD symptoms 3. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians 4. Pregnancy or lactation Group B (CVRD controls) 1. Any other co-existing disorder generating CVRD symptoms 2. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians 3. Pregnancy or lactation Group C (COVID-19 survivors) 1. Medical history of severe congestive heart failure (Stage III-IV) 2. Medical history of stage III or IV dyspnoea according to the New York Heart Association classification before the acute COVID-19 3. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians 4. Pregnancy or lactation Group D (sCAP survivors) 1. Medical history of severe congestive heart failure (Stage III-IV) 2. Medical history of stage III or IV dyspnoea according to the New York Heart Association classification before the sCAP 3. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians 4. Pregnancy or lactation
Contact & Investigator
Prof. Evangelos Giamarellos-Bourboulis
STUDY CHAIR
Hellenic Institute for the Study of Sepsis
Frequently Asked Questions
Who can join the NCT06601998 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pneumonia, Community-Acquired. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06601998 currently recruiting?
Yes, NCT06601998 is actively recruiting participants. Contact the research team at egiamarel@med.uoa.gr for enrollment information.
Where is the NCT06601998 trial being conducted?
This trial is being conducted at Alexandroupoli, Greece, Athens, Greece, Athens, Greece, Athens, Greece and 11 additional locations.
Who is sponsoring the NCT06601998 clinical trial?
NCT06601998 is sponsored by Hellenic Institute for the Study of Sepsis. The principal investigator is Prof. Evangelos Giamarellos-Bourboulis at Hellenic Institute for the Study of Sepsis. The trial plans to enroll 650 participants.