Pneumonia, Community-AcquiredHOMI-LUNG CAPNCT06601998
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
An observational study of Pneumonia, Community-Acquired and COVID-19 Pneumonia, run by Hellenic Institute for the Study of Sepsis at 19 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Community-Acquired, COVID-19 Pneumonia, Cardiovascular Diseases
- What is being tested?
- Blood samples and Oropharyngeal swab and Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptoms
- How many people
- 650 participants
- Where
- 19 sitesGreece
- Study dates
- 8 Nov 2024to 8 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 16Show fewer
- 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.
- SoC treatment for sCAP with antibiotics
Who cannot join
- 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)
Show all 19Show fewer
- 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)
- 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 sCAP
- 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
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
Greece19 sites, 19 recruiting
- Not yet recruiting
2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
Alexandroupoli
Assoc. Prof. Periklis Panagopoulos, 00302551351592, ppanago@med.duth.gr
- Recruiting
10th Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases
Athens
Dr. Ilias Kainis, 00302107771118, elikas60@gmail.com
- Recruiting
1st Department of Internal Medicine, General Hospital of Athens G. GENNIMATAS
Athens
Dr Georgios Adamis, 00302132032535, geo.adamis@gmail.com
- Recruiting
1st Department of Internal Medicine, General Hospital of Athens KORGIALENIO-BENAKIO E.E.S.
Athens
Dr. Vasiliki Tzavara, 00302132068843, vtzavara2015@gmail.com
- Recruiting
1st Department of Internal Medicine, General Hospital of Voula ASKLEPIEIO
Athens
Dr Charilaos Samaras, 00302132163959, xarisamar@gmail.com
- Recruiting
1st Intensive Care Clinic of the Medical School of the University of Athens, Evangelismos General Hospital
Athens
Prof. Ioannis Kalomenidis, 00302132043307, ikalom@med.uoa.gr
- Recruiting
1st University Department of Internal Medicine, General Hospital of Athens LAIKO
Athens
Prof. Michael Samarkos, 0030213 2061693, msamarkos@gmail.com
- Recruiting
1st University Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases
Athens
Assoc. Prof. Nikoletta Rovina, 00302107763452, nikrovina@med.uoa.gr
- Recruiting
2nd Department of Internal Medicine, General Hospital of Voula ASKLEPIEIO
Athens
Dr. Apostolos Maras, 00302132163967, dr_tolismaras@yahoo.gr
- Recruiting
2nd Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases
Athens
Dr. Aimilia Tsaroucha, 00302107773508, emilygeola@yahoo.gr
- Recruiting
3rd University Department of Internal Medicine, Sotiria Athens Hospital of Chest Diseases
Athens
Assoc. Prof. Garyfallia Poulakou, 00302107763439, gpoulakou@gmail.com
- Recruiting
4th Department of Internal Medicine, ATTIKON University General Hospital
Athens
Prof. Evangelos Giamarellos-Bourboulis, 00302105831994, egiamarel@med.uoa.gr
- Recruiting
Intensive Care Unit, General Hospital of Voula ASKLEPIEIO
Athens
Dr Aikaterini Ioakeimidou, 00302132163223, katioakim@gmail.com
- Recruiting
Out-patients clinic, General Hospital of Voula ASKLEPIEIO
Athens
Dr Sofia Nikolakopoulou, 00306944479683, sofnikol@yahoo.gr
- Recruiting
1st Department of Internal Medicine, Thriasio General Hospital of Elefsina
Elefsina
Dr. Styliani Symbardi, 00302132028497, lianasympa@hotmail.com
- Not yet recruiting
Department of Internal Medicine, University General Hospital of Patras PANAGIA I VOITHIA
Pátrai
Prof. Karolina Akinosoglou, 00302613603582, akin@upatras.gr
- Not yet recruiting
1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki
Thessaloniki
Prof. Simeon Metallidis, 00302313303110, metallidissimeon@yahoo.gr
- Not yet recruiting
Intensive Care Unit 2, AHEPA University General Hospital of Thessaloniki
Thessaloniki
Assoc. Prof. Eleni Argyriadou, 00302313303868, argiriadouhelena@hotmail.gr
- Not yet recruiting
Intensive Care Unit, "Ippokrateion" General Hospital of Thessaloniki
Thessaloniki
Dr. Eleni Mouloudi, 00302313312358, elmoulou@yahoo.gr
About this study
Official title: A Non-interventional, Prospective, Cross-sectional Study of Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Sars-Cov-2
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.
Read the detailed description
Post-acute pneumonia syndrome People believe that there is a "modern pandemic" beyond the pandemic. This is called the post-acute COVID syndrome (PACS), and it is a constellation of symptoms and medical entities which emerge after acute infection by the new coronavirus SARS-CoV-2 (COVID-19). However, in this definition, people are attracted by the apparent symptomatology and ignore that long-term complications may be even more severe. In this regard, it is reported that the incidence of type 2 diabetes mellitus (T2DM) is increasing almost 1.56-fold after acute COVID-19, which may happen without any symptoms. The increase in the incidence of T2DM is supported by two large-scale meta-analyses involving more than 4.2 million patients during the post-COVID-19 follow-up period.
Recent evidence from the Hellenic Sepsis Study group suggests that circulating monocytes of patients after the acute COVID- 19 illness have increased ability for the biosynthesis of interleukin (IL)-1β, many of them do not present symptoms of PACS.
Taking into consideration the importance of IL-1β for the pathogenesis of T2DM through the destruction of β-pancreatic cell islets, it is evident that increased cardiometabolic (CV) risk may also be a counterpart of PACS. In the CANTOS randomized clinical trial published several years ago, survivors of a first myocardial infarct were randomized to treatment with a placebo or canakinumab, one monoclonal antibody targeting IL-1β, for five years. Results showed that anti-IL-1 treatment decreased by 15% the incidence of secondary cardiovascular events outscoring excess IL-1β production as a driver of CV risk. Consequently, it is reasonable to hypothesize that COVID-19 survivors who over-produce IL-1β may present with long-term CV events.
Beyond state of the art: respiratory dysbiosis, a complete reappraisal of the physiopathology of pneumonia for innovative treatments Healthy distal airways have long been considered sterile, and pneumonia was thus supposed to be caused by the contamination of the lungs by exogenous virulent pathogens (for CAP) or during micro- aspirations of the digestive contents in comatose patients (for HAP). Based on this physiopathology, numerous strategies to rapidly eliminate pathogens are recommended and widely used in Europe and worldwide. However, the limits of CAP and HAP treatments which increase bacterial or viral clearance, are highlighted in almost all randomized trials evaluating antibiotics or antiviral drugs in which the rates of treatment failure commonly exceed 30%, and by the 30%-rate of patients presenting with prolonged symptoms after pathogen clearance. A reappraisal of the physiopathology of pneumonia seemed necessary to overcome the relative failure and improve patient outcomes.
We have demonstrated that pneumonia outcomes depend on pathogen clearance and restoring healthy interactions between a weakened microbiome and altered immunity. Since CVRD progression is associated with disruption of the host-microbiome interactions, we hypothesize that the dysbiosis induced by pneumonia participates in the CVRD progression reported after the infection recovery. We thus propose to perform i) a longitudinal follow-up of host-microbiome interactions in large cohorts of patients cured of pneumonia to demonstrate clinically meaningful associations between immune reprogramming, microbiome dysbiosis and CVRD progression, and ii) preclinical investigations in calibrated mice models to demonstrate causality between dysbiosis and CVRD progression.
It is now well established that airways harbour a rich and diverse microbiome in healthy controls. Respiratory tract invasion by pathogens rapidly causes a loss of microbiome diversity and an impoverishment of host-microbiome interactions. These respiratory microbiome alterations play an essential role in the development of lung inflammation during pneumonia and reflect variation in baseline lung innate immunity. In published studies of mechanically ventilated patients, it has been demonstrated that lung microbiota are correlated with alveolar inflammation and that disruption of the gut microbiome (via anti-anaerobic antibiotics) increases patients risk of prolonged mechanical ventilation and mortality. These studies demonstrate the clinical significance of the microbiome in recovery from lung injury. Alterations of the gut microbiome derived metabolites also participate in the long-term immune reprogramming observed after sepsis.
In the healthy state, respiratory mucosal immunity actively controls the commensal bacterial agents in the airways. Numerous studies have revealed profound immune alterations in septic patients, considered immunocompetent" at the time of hospitalization. Partner Nantes Université has demonstrated that pneumonia induces prolonged immune reprogramming, characterized by the formation of paralyzed dendritic cells (DCs) and low phagocytic alveolar macrophages (MAC), that lasts for months in humans and is associated with prolonged susceptibility to bacterial and viral respiratory infections. These results demonstrate that the required immune response to contain respiratory pathogens and interact with the microbiome is rapidly dampened during pneumonia and that this immune reprogramming lasts for years.
Critically ill patients are highly variable in their recovery from lung injury. Much of this variation is attributable to the differential recovery of alveolar epithelial cell integrity and function. An improved understanding of lung epithelial recovery will be necessary to identify therapeutic targets for resolving lung injury and preventing CVRD progression. Lung epithelial cells are subject to constant exposure to 1) microbiota within the respiratory tract and 2) metabolites and translocated bacterial products from the lower gut microbiome. Yet the role of the microbiome in alveolar epithelial recovery is undetermined.
As a summary, we propose a reappraisal of the physiopathology of pneumonia based on the concept of dysbiosis between a weakened microbiome and sepsis-induced immunosuppression, which have the potential to explain the prolonged susceptibility to non-communicable diseases, notably by sustaining epithelial injuries.
Role of host-microbiome interactions in CVRD progression Current pharmaceutical interventions designed to slow the progression of atherosclerosis focus almost exclusively on reducing plasma cholesterol levels. However, clinical and experimental data support an additional critical role for inflammation in atherothrombosis. Notably, inflammation inhibition targeting the central NLRP3 inflammasome to IL-1 to IL-6 pathway of innate immunity is an emerging method for atherosclerosis treatment and prevention. Macrophage accumulation within the vascular wall is a hallmark of atherosclerosis, and in atherosclerotic lesions, macrophages respond to various environmental stimuli, such as modified lipids and cytokines. We have demonstrated that trained immunity develops early during pneumonia, correlates with the inflammatory response, and can help to predict long-term outcomes after viral pneumonia.
This innate immune reprogramming, lasts for months after sepsis recovery and is characterized by exacerbated inflammatory response and prolonged decrease phagocytic activity of monocytes and macrophages during secondary immune stimulation. We thus propose that the functional reprogramming of monocytes and macrophages observed after pneumonia, can alter the control of atherosclerosis plaques, increasing the risk of major CVD events. The gut microbiome has also emerged as a central factor affecting type 2 diabetes, obesity and the progression of atherosclerotic cardiovascular disease.
Integration of host-microbiome interactions to model the response to pneumonia and identify patients at risk of unfavourable outcomes early Each patient likely responds differently to therapeutic intervention and might recover differently after pneumonia. Indeed, some subgroups of patients suffer rapid CVRD progression, and others return to baseline conditions. Several biomarkers have been associated with pneumonia outcomes, but none have reached the accuracy required for clinical implementation. This is mainly because they are usually developed in small mono-centre cohorts and analyzed separately in the microbiome and host status. So, pneumonia treatments and rehabilitation care are "one-fits-all patients" approach leading to a large proportion of treatment failures and CVRD progression.
There is a critical need for reliable biomarkers for the stratification of patients predicting therapy success/failure and risk of CVRD progression/severe. The gold standard to reach these objectives is to use large cohorts of patients, bar coding of the samples, and high-throughput analysis followed by unbiased algorithm-guided analysis. In this setting, the description that the integration of the host response and the microbiome composition have a fair accuracy for the diagnosis of pneumonia demonstrates the potential of protocols investigating the host/microbiome interactions for the development of personalized treatment for respiratory infections.
The development and validation of endotypes to better understand the functional mechanisms associated with CVRD progression will help clinicians to adapt treatment and better prevent these conditions. The definition of phenotypes will also help identify patients at risk early. We thus propose to combine host background (sex/gender, age, ethnicity, medical history and genetic susceptibility, vaccination), CVRD risk factors (dyslipidemia, diabetes, obesity), inflammation and soluble mediators (metabolome, cytokines), immune status (epigenetic regulation) and microbiome composition during and after pneumonia to capture the complexity of the hostmicrobiome interaction time course and define endotypes and phenotypes associating pneumonia with CVRD.
- Being tested
- Blood samples and Oropharyngeal swab, Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptoms
- Keywords
- Covid-19, SARS-CoV-2, Lung infection, Cardiovascular disease, Respiratory disease, Endotypes, Biomarkers, Cardiorespiratory, Economic cost
- Medical subject headings
- Community-Acquired Pneumonia, Cardiovascular Diseases, COVID-19, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples and Oropharyngeal swabOther
Blood samples: EDTA-plasma (proteome, metabolome and lipidome) and PBMCs (transcriptome, epigenome, immune-phenotype and genetic polymorphism)
Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptomsOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Controls with no or one comorbidity, predisposing to significant CV events and without a medical history of severe pneumonia. Receives: Other: Blood samples and Oropharyngeal swab | |
| CVRD controls | Controls with comorbidities predisposing to major CV events and without a medical history of severe pneumonia Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From enrollment to Month 36.
Secondary outcomes (14)
Rates of unplanned hospitalisation
Rates of unplanned hospitalisation
Measured: From enrollment to Month 36.
Rates of COPD exacerbation, hospitalization for respiratory failure and/or respiratory-related mortality at 3 years
Rates of COPD exacerbation, hospitalization for respiratory failure and/or respiratory-related mortality at 3 years
Measured: From enrollment to Month 36.
Rates of secondary episodes of pneumonia, the incidence of non-respiratory infections
Rates of secondary episodes of pneumonia, the incidence of non-respiratory infections
Measured: From enrollment to Month 36.
The rates of major cardiovascular disease event and of poor cardiorespiratory fitness
The rates of major cardiovascular disease event at 6 months and of poor cardiorespiratory fitness at 36 months according to the microbiology of sCAP (viral vs bacterial vs mixed etiology)
Measured: At 6 and 36 months
The rates of major cardiovascular disease event and of poor cardiorespiratory fitness
The rates of major cardiovascular disease event at 6 months and of poor cardiorespiratory fitness at 36 months according to the antibiotic treatments for sCAP
Measured: At 6 and 36 months
Changes in health-related quality of life (HRQoL)
Changes in health-related quality of life (HRQoL) from six (M6) to eighteen months (M18) after hospital discharge measured with the Short Form (SF)-36 scale validated in Greek and Spanish
Measured: From six (M6) to eighteen months (M18) after hospital discharge
Changes in anxiety and depression
Changes in anxiety and depression from M6 to M18, measured with the Hospital Anxiety and Depression Scale (HADS) validated in Greek and Spanish
Measured: From Month 6 to Month 18
Changes in subjective well-being
Changes in subjective well-being from M6 to M18 measured with the Satisfaction With Life Scale (SWLS) validated in Greek and Spanish.
Measured: From Month 6 to Month 18
New metabolic disease
New metabolic disease, as evaluated by laboratory tests: diabetes (HbA1c \> 6.5%), dyslipidemia, denutrition (pre-albumin and albumin blood levels) at hospital discharge, M6 and M18
Measured: At hospital discharge (i.e. an average of 1 Month after enrollment), Month 6 and Month18
Distance at the 6-min walk-test
Distance at the 6-min walk-test at hospital discharge, M6 and M18
Measured: At hospital discharge (i.e. an average of 1 Month after enrollment), Month 6 and Month18
Mean values of lung functions
Mean values of lung functions (maximum expiratory volume per second, vital capacity, expiratory reserve volume and inspiratory reserved volume, DLC50) at hospital discharge, M6 and M18
Measured: At hospital discharge (i.e. an average of 1 Month after enrollment), Month 6 and Month18
Cardiopulmonary exercise stress testing
Cardiopulmonary exercise stress testing: VO2Max at hospital discharge, M6 and M18
Measured: At hospital discharge (i.e. an average of 1 Month after enrollment), Month 6 and Month18
ECG: Percentages of patients with rhythm cardiac alterations, repolarisation abnormality
ECG: Percentages of patients with rhythm cardiac alterations, repolarisation abnormality at hospital discharge, M6 and M18
Measured: At hospital discharge (i.e. an average of 1 Month after enrollment), Month 6 and Month18
Mean values of left ventricular ejection fraction
Mean values of left ventricular ejection fraction at hospital discharge, M6 and M18
Measured: At hospital discharge (i.e. an average of 1 Month after enrollment), Month 6 and Month18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Nov 2024
- Primary completion8 Nov 2027 (estimated)
- Study completion8 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Community-AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Institute for the Study of Sepsis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof. Evangelos Giamarellos-Bourboulis, Study chair, Hellenic Institute for the Study of Sepsis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601998
- Sponsor's protocol ID
- HOMI-LUNG CAP
- Acronym
- HOMI-LUNG CAP
- Status last verified
- Nov 2025
- First submitted
- 16 Sep 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Prospective, Cross-sectional Study of Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Sars-Cov-2
- ClinicalTrials.gov ID
- NCT06601998
- Acronym / sponsor ID
- HOMI-LUNG CAP / HOMI-LUNG CAP
- Keywords
- Covid-19, SARS-CoV-2, Lung infection, Cardiovascular disease, Respiratory disease, Endotypes, Biomarkers, Cardiorespiratory
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Hellenic Institute for the Study of SepsisUniversity, hospital or other
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 8 Nov 2027 (estimated)
- Study completion
- 8 Jun 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Post-acute pneumonia syndrome People believe that there is a "modern pandemic" beyond the pandemic. This is called the post-acute COVID syndrome (PACS), and it is a constellation of symptoms and medical entities which emerge after acute infection by the new coronavirus SARS-CoV-2 (COVID-19). However, in this definition, people are attracted by the apparent symptomatology and ignore that long-term complications may be even more severe. In this regard, it is reported that the incidence of type 2 diabetes mellitus (T2DM) is increasing almost 1.56-fold after acute COVID-19, which may happen without any symptoms. The increase in the incidence of T2DM is supported by two large-scale meta-analyses involving more than 4.2 million patients during the post-COVID-19 follow-up period.
Recent evidence from the Hellenic Sepsis Study group suggests that circulating monocytes of patients after the acute COVID- 19 illness have increased ability for the biosynthesis of interleukin (IL)-1β, many of them do not present symptoms of PACS.
Taking into consideration the importance of IL-1β for the pathogenesis of T2DM through the destruction of β-pancreatic cell islets, it is evident that increased cardiometabolic (CV) risk may also be a counterpart of PACS. In the CANTOS randomized clinical trial published several years ago, survivors of a first myocardial infarct were randomized to treatment with a placebo or canakinumab, one monoclonal antibody targeting IL-1β, for five years. Results showed that anti-IL-1 treatment decreased by 15% the incidence of secondary cardiovascular events outscoring excess IL-1β production as a driver of CV risk. Consequently, it is reasonable to hypothesize that COVID-19 survivors who over-produce IL-1β may present with long-term CV events.
Beyond state of the art: respiratory dysbiosis, a complete reappraisal of the physiopathology of pneumonia for innovative treatments Healthy distal airways have long been considered sterile, and pneumonia was thus supposed to be caused by the contamination of the lungs by exogenous virulent pathogens (for CAP) or during micro- aspirations of the digestive contents in comatose patients (for HAP). Based on this physiopathology, numerous strategies to rapidly eliminate pathogens are recommended and widely used in Europe and worldwide. However, the limits of CAP and HAP treatments which increase bacterial or viral clearance, are highlighted in almost all randomized trials evaluating antibiotics or antiviral drugs in which the rates of treatment failure commonly exceed 30%, and by the 30%-rate of patients presenting with prolonged symptoms after pathogen clearance. A reappraisal of the physiopathology of pneumonia seemed necessary to overcome the relative failure and improve patient outcomes.
We have demonstrated that pneumonia outcomes depend on pathogen clearance and restoring healthy interactions between a weakened microbiome and altered immunity. Since CVRD progression is associated with disruption of the host-microbiome interactions, we hypothesize that the dysbiosis induced by pneumonia participates in the CVRD progression reported after the infection recovery. We thus propose to perform i) a longitudinal follow-up of host-microbiome interactions in large cohorts of patients cured of pneumonia to demonstrate clinically meaningful associations between immune reprogramming, microbiome dysbiosis and CVRD progression, and ii) preclinical investigations in calibrated mice models to demonstrate causality between dysbiosis and CVRD progression.
It is now well established that airways harbour a rich and diverse microbiome in healthy controls. Respiratory tract invasion by pathogens rapidly causes a loss of microbiome diversity and an impoverishment of host-microbiome interactions. These respiratory microbiome alterations play an essential role in the development of lung inflammation during pneumonia and reflect variation in baseline lung innate immunity. In published studies of mechanically ventilated patients, it has been demonstrated that lung microbiota are correlated with alveolar inflammation and that disruption of the gut microbiome (via anti-anaerobic antibiotics) increases patients risk of prolonged mechanical ventilation and mortality. These studies demonstrate the clinical significance of the microbiome in recovery from lung injury. Alterations of the gut microbiome derived metabolites also participate in the long-term immune reprogramming observed after sepsis.
In the healthy state, respiratory mucosal immunity actively controls the commensal bacterial agents in the airways. Numerous studies have revealed profound immune alterations in septic patients, considered immunocompetent" at the time of hospitalization. Partner Nantes Université has demonstrated that pneumonia induces prolonged immune reprogramming, characterized by the formation of paralyzed dendritic cells (DCs) and low phagocytic alveolar macrophages (MAC), that lasts for months in humans and is associated with prolonged susceptibility to bacterial and viral respiratory infections. These results demonstrate that the required immune response to contain respiratory pathogens and interact with the microbiome is rapidly dampened during pneumonia and that this immune reprogramming lasts for years.
Critically ill patients are highly variable in their recovery from lung injury. Much of this variation is attributable to the differential recovery of alveolar epithelial cell integrity and function. An improved understanding of lung epithelial recovery will be necessary to identify therapeutic targets for resolving lung injury and preventing CVRD progression. Lung epithelial cells are subject to constant exposure to 1) microbiota within the respiratory tract and 2) metabolites and translocated bacterial products from the lower gut microbiome. Yet the role of the microbiome in alveolar epithelial recovery is undetermined.
As a summary, we propose a reappraisal of the physiopathology of pneumonia based on the concept of dysbiosis between a weakened microbiome and sepsis-induced immunosuppression, which have the potential to explain the prolonged susceptibility to non-communicable diseases, notably by sustaining epithelial injuries.
Role of host-microbiome interactions in CVRD progression Current pharmaceutical interventions designed to slow the progression of atherosclerosis focus almost exclusively on reducing plasma cholesterol levels. However, clinical and experimental data support an additional critical role for inflammation in atherothrombosis. Notably, inflammation inhibition targeting the central NLRP3 inflammasome to IL-1 to IL-6 pathway of innate immunity is an emerging method for atherosclerosis treatment and prevention. Macrophage accumulation within the vascular wall is a hallmark of atherosclerosis, and in atherosclerotic lesions, macrophages respond to various environmental stimuli, such as modified lipids and cytokines. We have demonstrated that trained immunity develops early during pneumonia, correlates with the inflammatory response, and can help to predict long-term outcomes after viral pneumonia.
This innate immune reprogramming, lasts for months after sepsis recovery and is characterized by exacerbated inflammatory response and prolonged decrease phagocytic activity of monocytes and macrophages during secondary immune stimulation. We thus propose that the functional reprogramming of monocytes and macrophages observed after pneumonia, can alter the control of atherosclerosis plaques, increasing the risk of major CVD events. The gut microbiome has also emerged as a central factor affecting type 2 diabetes, obesity and the progression of atherosclerotic cardiovascular disease.
Integration of host-microbiome interactions to model the response to pneumonia and identify patients at risk of unfavourable outcomes early Each patient likely responds differently to therapeutic intervention and might recover differently after pneumonia. Indeed, some subgroups of patients suffer rapid CVRD progression, and others return to baseline conditions. Several biomarkers have been associated with pneumonia outcomes, but none have reached the accuracy required for clinical implementation. This is mainly because they are usually developed in small mono-centre cohorts and analyzed separately in the microbiome and host status. So, pneumonia treatments and rehabilitation care are "one-fits-all patients" approach leading to a large proportion of treatment failures and CVRD progression.
There is a critical need for reliable biomarkers for the stratification of patients predicting therapy success/failure and risk of CVRD progression/severe. The gold standard to reach these objectives is to use large cohorts of patients, bar coding of the samples, and high-throughput analysis followed by unbiased algorithm-guided analysis. In this setting, the description that the integration of the host response and the microbiome composition have a fair accuracy for the diagnosis of pneumonia demonstrates the potential of protocols investigating the host/microbiome interactions for the development of personalized treatment for respiratory infections.
The development and validation of endotypes to better understand the functional mechanisms associated with CVRD progression will help clinicians to adapt treatment and better prevent these conditions. The definition of phenotypes will also help identify patients at risk early. We thus propose to combine host background (sex/gender, age, ethnicity, medical history and genetic susceptibility, vaccination), CVRD risk factors (dyslipidemia, diabetes, obesity), inflammation and soluble mediators (metabolome, cytokines), immune status (epigenetic regulation) and microbiome composition during and after pneumonia to capture the complexity of the hostmicrobiome interaction time course and define endotypes and phenotypes associating pneumonia with CVRD.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Other: Blood samples and Oropharyngeal swabControls with no or one comorbidity, predisposing to significant CV events and without a medical history of severe pneumonia. |
| CVRD controls | – | Other: Blood samples and Oropharyngeal swab, Other: Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptomsControls with comorbidities predisposing to major CV events and without a medical history of severe pneumonia |
| COVID-19 survivors | – | Other: Blood samples and Oropharyngeal swab, Other: Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptomsPatients cured of acute COVID-19 |
| sCAP survivors | – | Other: Blood samples and Oropharyngeal swab, Other: Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptomsPatients cured of severe community-acquired pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples and Oropharyngeal swabBlood samples: EDTA-plasma (proteome, metabolome and lipidome) and PBMCs (transcriptome, epigenome, immune-phenotype and genetic polymorphism) | Other | COVID-19 survivors, CVRD controls, Healthy controls, sCAP survivors |
| Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptoms* 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 | Other | COVID-19 survivors, CVRD controls, sCAP survivors |
Primary outcome
The first primary outcome is the rates of major cardiovascular disease event at 6 months.
Time frame: From enrollment to Month 6.
Major CVD events are all-cause mortality, stroke, non-fatal acute coronary syndrome, pulmonary embolism or venous thrombosis
The second primary endpoint is poor cardiorespiratory fitness at 36 months.
Time frame: From enrollment to Month 36.
Poor fitness is a VO2max lower than normal values for age.
14 secondary outcomes
Rates of unplanned hospitalisation
Time frame: From enrollment to Month 36.
Rates of COPD exacerbation, hospitalization for respiratory failure and/or respiratory-related mortality at 3 years
Time frame: From enrollment to Month 36.
Rates of secondary episodes of pneumonia, the incidence of non-respiratory infections
Time frame: From enrollment to Month 36.
The rates of major cardiovascular disease event and of poor cardiorespiratory fitness
Time frame: At 6 and 36 months
The rates of major cardiovascular disease event and of poor cardiorespiratory fitness
Time frame: At 6 and 36 months
Changes in health-related quality of life (HRQoL)
Time frame: From six (M6) to eighteen months (M18) after hospital discharge
Changes in anxiety and depression
Time frame: From Month 6 to Month 18
Changes in subjective well-being
Time frame: From Month 6 to Month 18
New metabolic disease
Time frame: At hospital discharge (i.e. an average of 1 Month after enrollment), Month 6 and Month18
Distance at the 6-min walk-test
Time frame: At hospital discharge (i.e. an average of 1 Month after enrollment), Month 6 and Month18
Mean values of lung functions
Time frame: At hospital discharge (i.e. an average of 1 Month after enrollment), Month 6 and Month18
Cardiopulmonary exercise stress testing
Time frame: At hospital discharge (i.e. an average of 1 Month after enrollment), Month 6 and Month18
ECG: Percentages of patients with rhythm cardiac alterations, repolarisation abnormality
Time frame: At hospital discharge (i.e. an average of 1 Month after enrollment), Month 6 and Month18
Mean values of left ventricular ejection fraction
Time frame: At hospital discharge (i.e. an average of 1 Month after enrollment), Month 6 and Month18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
Related trials for Pneumonia, Community-Acquired
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Evangelos Giamarellos-Bourboulis study chair
Hellenic Institute for the Study of Sepsis
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Community-Acquired and COVID-19 Pneumonia, run by Hellenic Institute for the Study of Sepsis at 19 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Evangelos Giamarellos-Bourboulis (00302105831994, egiamarel@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first primary outcome is the rates of major cardiovascular disease event at 6 months. (time frame: From enrollment to Month 6.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.