[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hellenic Institute for the Study of Sepsis\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":175},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,52,83,114,145],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100562348","cardiovascular-disease-progression-in-survivors-of-community-acquired-pneumonia-and-lung-infection-by-covid-19-100562348",false,"NCT06601998","Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.","A Non-interventional, Prospective, Cross-sectional Study of Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Sars-Cov-2","HOMI-LUNG CAP","Inclusion Criteria:\n\nGroup A (healthy controls)\n\n1. Adults (18 years or more) of both genders (Female\u002FMale: 50\u002F50 ratio)\n2. No history of severe pneumonia (sCAP, COVID-19 or HAP)\n3. Presence of no or one of the following comorbidities: obesity (defined as body mass index over 35 kg\u002Fm2), type 2 diabetes mellitus, hypercholesterolemia, essential arterial hypertension, or familial history of CVD.\n\nGroup B (CVRD controls)\n\n1. Adults (18 years or more) of both genders (Female\u002FMale ratio: 50\u002F50)\n2. No history of severe pneumonia (sCAP, COVID-19 or HAP)\n3. At least two of the following comorbidities: obesity (defined as body mass index over 35 kg\u002Fm2), type 2 diabetes mellitus, hypercholesterolemia, essential arterial hypertension, or familial history of CVD\n\nGroup C (COVID-19 survivors)\n\n1. Adults (18 years or more) of both genders (Female\u002FMale ratio: 50\u002F50)\n2. 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\n3. SoC treatment for acute COVID-19 with dexamethasone\n\nGroup D (sCAP survivors)\n\n1. Adults (18 years or more) of both genders\n2. 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.\n3. SoC treatment for sCAP with antibiotics\n\nExclusion Criteria:\n\nGroup A (healthy controls)\n\n1. Presence of two or more comorbidities\n2. Any other co-existing disorder generating CVRD symptoms\n3. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians\n4. Pregnancy or lactation\n\nGroup B (CVRD controls)\n\n1. Any other co-existing disorder generating CVRD symptoms\n2. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians\n3. Pregnancy or lactation\n\nGroup C (COVID-19 survivors)\n\n1. Medical history of severe congestive heart failure (Stage III-IV)\n2. Medical history of stage III or IV dyspnoea according to the New York Heart Association classification before the acute COVID-19\n3. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians\n4. Pregnancy or lactation\n\nGroup D (sCAP survivors)\n\n1. Medical history of severe congestive heart failure (Stage III-IV)\n2. Medical history of stage III or IV dyspnoea according to the New York Heart Association classification before the sCAP\n3. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians\n4. Pregnancy or lactation",true,"ALL","18 Years",{"count":21,"type":22},650,"ESTIMATED","OBSERVATIONAL","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.\n\nThe overall concept underpinning \"Homi-lung\" is to investigate the time course of host-microbiome interactions during \\&amp;amp;amp; 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 \\&amp;amp;amp; CVRD history; iii) develop biomarkers to predict the individual response to the treatment \\&amp;amp;amp; CVRD progression, and iv) preclinically validate therapeutical approaches for CVRD during \\&amp;amp;amp; after pneumonia.",[26,27,28],"Pneumonia, Community-Acquired","COVID-19 Pneumonia","Cardiovascular Diseases",[30,31,32,33,34,35,36,37,38],"Covid-19","SARS-CoV-2","Lung infection","Cardiovascular disease","Respiratory disease","Endotypes","Biomarkers","Cardiorespiratory","Economic cost","RECRUITING","2026-06-09",{"date":42,"type":43},"2026-06-10","ACTUAL",{"date":45,"type":43},"2024-11-08",{"date":47,"type":22},"2028-06-08",{"name":49,"class":50},"Hellenic Institute for the Study of Sepsis","OTHER",18,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100510443","phase-2-safety-and-efficacy-of-anakinra-treatment-for-patients-with-post-acute-covid-syndrome-100510443","NCT05926505","Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome","Safety and Efficacy of Anakinra Treatment for Patients With Persistent Respiratory Symptoms Post Acute Covid and Immune System Activation: the Precision Double-blind, Randomized Clinical Trial","PRECISION","Inclusion Criteria:\n\n1. Age equal to or above 18 years\n2. Male or female gender\n3. In the case of women of childbearing age and men, an adequate method of contraception should be used during the study. Contraception should be maintained for at least a period of 3 months after the discontinuation of treatment. As an adequate method of contraception, it is suggested: -male or female condom with or without spermicide -contraceptive cap, a diaphragm or contraceptive sponge with a spermicide Prior to admission to the study, a pregnancy test will be performed to exclude pregnancy to women of childbearing age.\n4. Written informed consent provided by the patient. For subjects without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation in the Member State where the trial is planned.\n5. History of confirmed COVID-19 infection the last 90 days or more\n6. Symptoms compatible with PACS (defined as at least one positive answer to the questionnaire for restriction of daily activities) lasting for more than 2 months\n7. Serum levels of IP-10 more than 250 pg\u002Fml\n8. Presence of ONE of the following two clinical conditions: Condition 1: Impaired Lung Function tests (defined as: DLCOcor \\\u003C76% AND TLC and\u002For FVC lower than 80% of predicted) Condition 2: At least a total radiology score in HRCT more than 20 OR walking of a distance less than 500m in the 6-minute walk test\n\nIf patients meet the criteria for both Conditions 1 and 2, they will be considered for randomization and evaluation for the primary endpoint as in Condition 1.\n\nExclusion Criteria:\n\n1. Age below 18 years\n2. Denial for written informed consent\n3. Any stage IV malignancy\n4. Any primary immunodeficiency\n5. Less than 1,500 neutrophils\u002Fmm3\n6. Known hypersensitivity to anakinra\n7. Known lung fibrosis prior to COVID-19\n8. Medical history of pulmonary hypertension or chronic heart failure\n9. Known chronic obstructive pulmonary disease GOLD stage 3 or 4 prior to COVID-19\n10. Known active tuberculosis (under treatment) or latent tuberculosis (by positive tuberculin test)\n11. Oral or IV intake of corticosteroids at a daily dose equal or greater than 0.4 mg\u002Fkg prednisone for a period greater than the last 15 days.\n12. Any anti-cytokine biological treatment the last one month\n13. Severe hepatic failure defined as Child-Pugh stage of 3\n14. End-stage renal failure necessitating hemofiltration or peritoneal hemodialysis\n15. Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study\n16. Participation in any other interventional trial",{"count":61,"type":22},182,"INTERVENTIONAL",[64,65],"PHASE2","PHASE3","The PRECISION is a proof-of-concept, phase II randomized clinical trial aiming to evaluate the efficacy and safety of anakinra in patients with Post-Acute COVID Syndrome (PACS) of the pro-inflammatory respiratory phenotype. Improvement is measured by a composite endpoint, namely, the \"Score of PACS progression reversal\"",[68,69,70],"Post-Acute COVID-19 Syndrome","Post-Acute COVID-19","Long COVID",[72,70,69,73,58,55],"COVID-19","Anakinra","2026-01-06",{"date":76,"type":43},"2026-01-08",{"date":78,"type":43},"2023-09-06",{"date":80,"type":22},"2028-03",{"name":49,"class":50},24,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":62,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":82},"100538727","phase-3-clarithromycin-treatment-to-prevent-sepsis-progression-in-cap-react-100538727","NCT06294600","Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)","Biomarker-Guided Early Elarithromycin Treatment to Prevent Sepsis Progression in Community-Acquired Pneumonia: The React Randomized Clinical Trial","REACT","Inclusion Criteria:\n\n* Age equal to or above 18 years\n* Male or female gender\n* In case of women of reproductive age, willingness to use dual contraceptive method during the study period\n* Written informed consent provided by the patient. For subjects without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation\n* Community-acquired pneumonia (CAP)\n* Presence of at least two of the following signs: i) cough; ii) purulent sputum expectoration; iii) dyspnea; and\u002For iv) pleuritic chest pain\n* PCT ≥0.25 ng\u002Fml\n* suPAR ≥6 ng\u002Fml\n\nExclusion Criteria:\n\n* Age below 18 years\n* Denial of written informed consent\n* Any stage IV malignancy\n* Any do not resuscitate decision\n* Patients necessitating non-invasive ventilation or mechanical ventilation\n* Hospitalization in Intensive Care Unit\n* Infection by SARS-CoV-2\n* Oral or IV intake of corticosteroids at a daily dose equal to or greater than 0.4 mg\u002Fkg prednisone for a period greater than the last 15 days\n* Intake of any macrolide for the current episode of CAP under study\n* Known infection by the human immunodeficiency virus\n* Any chronic anti-cytokine treatment for more than two months\n* QTc interval at rest in the ECG ≥500 msec or history of know long QT syndrome\n* Medical history of allergy to macrolides\n* Concomitant oral intake of astemizole, cizapride, doperidone, pimozide, terfenadine, midazolam, ranolazine, ergot alkaloids (e.g. ergotamine and dihydroergotamine), lomitapide and colchicine; patients may be enrolled in the trial if they stop these drugs during trial participation.\n* Medical history of torsades de pointes arrhythmia\n* Concomitant intake of lovostatin or simvastatin; patients may be enrolled in the trial if they stop these drugs during trial participation.\n* Concomitant presence of end-stage liver failure and end-stage renal failure.\n* Severe hypokalemia or severe hypomagnesemia; a patient may be enrolled one any of these electrolyte disturbances are restored.\n* Any contradictions for macrolide uptake\n* Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study\n* Participation in any other interventional trial within the last 30 days",{"count":92,"type":22},330,[65],"The primary objective of the REACT randomized clinical trial (RCT) is to optimize the clinical benefit from adjunctive clarithromycin treatment shown in the ACCESS trial and to provide evidence for the clinical benefit of early start of adjunctive oral clarithromycin guided by suPAR to prevent the progression into sepsis in patients with community-acquired pneumonia (CAP) at risk. This can be achieved by endpoints incorporating clinical benefit with the effect of treatment on the improvement of the immune dysregulation of CAP. The secondary objectives of REACT are to investigate the impact of early adjunctive treatment with clarithromycin on the resolution of CAP at the test-of-cure (TOC) visit.",[96],"Community-acquired Pneumonia",[98,99,100,101,102,103,104,105],"CAP","CLARITHROMYCIN","SEPSIS","suPAR","PCT","ACCESS","SOFA","RSS","2025-12-15",{"date":108,"type":43},"2025-12-16",{"date":110,"type":43},"2024-02-12",{"date":112,"type":22},"2026-07-30",{"name":49,"class":50},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":124,"conditions":125,"keywords":129,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100562875","the-incidence-of-pulmonary-cardiovascular-and-renal-system-non-communicable-complications-associated-with-the-post-acute-phase-of-the-infection-by-covid-19-100562875","NCT06608849","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","POINT","Inclusion Criteria:\n\nGroup A (comparators)\n\n1. Adults (18 years or more) of both genders\n2. Negative history of acute COVID-19\n\nGroup B (patients with ΝΟ dysfunction)\n\n1. Adults (18 years or more) of both genders\n2. History of acute COVID-19 hospitalized or non-hospitalized. All cases appearing from start of the pandemic until the last six months may apply\n3. Absence of any current overt organ dysfunction\n4. Absence of signs of any organ dysfunction during acute COVID-19\n\nGroup C (patients with dysfunctions)\n\n1. Adults (18 years or more) of both genders\n2. History of acute COVID-19 hospitalized or non-hospitalized. All cases appearing from start of the pandemic until the last six months may apply\n3. Presence of signs of organ dysfunction of the lung, the kidneys or the heart during acute COVID-19\n\nExclusion Criteria:\n\nGroup A (comparators)\n\n1. Any other co-existing disorder generating clinical symptoms\n2. Failure to thrive according to the attending physicians\n3. Pregnancy or lactation\n\nGroup B (patients with ΝΟ dysfunction)\n\n1. Any other co-existing disorder generating clinical symptoms\n2. Failure to thrive according to the attending physicians\n3. Pregnancy or lactation\n\nGroup C (patients with dysfunctions)\n\n1. Any other co-existing disorder generating clinical symptoms\n2. Medical history of any of:\n\n   * stage III or IV chronic obstructive pulmonary disease according to the GOLD criteria\n   * pulmonary fibrosis or pulmonary hypertension\n   * stage IV solid tumour malignancy under chemotherapy or radiotherapy\n   * systemic sclerosis\n   * congestive heart failure\n   * stage II, III or IV dyspnoea according to the New York Heart Association classification before the acute COVID-19\n3. Limited chance of survival for at least six months due to co-existing comorbidity(-ies) according to the judgement of the attending physicians\n4. Pregnancy or lactation",{"count":123,"type":22},345,"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.\n\nThe 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.",[126,127,128,72],"Pulmonary Complications","Cardiovascular Complications","Renal Complications",[30,31,130,131,132,133,134,36,135],"Pulmonary complications","Cardiovascular complications","Renal complications","Post-acute phase","Non communicable diseases","Prevention","2025-11-14",{"date":138,"type":43},"2025-11-17",{"date":140,"type":43},"2024-12-10",{"date":142,"type":22},"2027-11-04",{"name":49,"class":50},6,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":155,"conditions":156,"keywords":159,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100598589","viscoelastic-coagulation-for-early-sepsis-detection-100598589","NCT07073456","Viscoelastic Coagulation for Early Sepsis Detection","Viscoelastic Coagulation Monitor as an Early Index of Sepsis in Patients Admitted With Infection at the Emergency Department: The VISION Project","VISION","Inclusion Criteria:\n\n* Adults male or female (age 18 years or more)\n* Suspicion of infection, defined according to medical judgment\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Denial for consent\n* Intake of any anti-coagulant medication the last one month\n* Intake of any anti-platelet medication the last one month\n* Intake of any biological disease modifying anti-rheumatic medication the last one month\n* Medical history of inflammatory bowel disease or pulmonary hypertension\n* Any medical history of hemophilia or congenital coagulation disorders\n* Any known solid tumor or hematologic malignancy irrespective the stage and treatment\n* Known infection by the hepatitis viruses B and C\n* Known infection by the human immunodeficiency virus\n* Pregnancy or lactation",{"count":154,"type":22},150,"The goal of this observational study is to investigate whether selected variables of coagulation measured by Viscoelastic Coagulation Monitoring (VCM) can serve as early predictors of progression to sepsis in adult patients presenting to the emergency department (ED) with suspected infection. The main questions it aims to answer are: Can any of the eight VCM-derived coagulation parameters predict early progression into sepsis? Is there a specific VCM profile associated with higher sepsis risk at ED presentation? Participants presenting to the Emergency Department with signs of suspected infection will be asked to provide written informed consent, either personally or via a legal representative. Upon consent, they will be enrolled in the study. All participants will undergo at the Emergency Department blood sampling for VCM analysis, for complete blood count, routine biochemical tests and inflammatory markers (e.g., CRP and procalcitonin). In case of discharge, patients will be contacted by phone for three consecutive days to monitor the course of infection and assess survival status. In case of admission, blood for VCM analysis will be collected daily for three consecutive days. This is a single-center, prospective proof-of-concept study conducted at ATTIKON University General Hospital in collaboration with the 4th Department of Internal Medicine.",[157,158],"Infection","Sepsis",[160,161,162,163,164,165],"blood coagulation","infection","sepsis","clot formation","Viscoelastic Coagulation Monitor","early sepsis detection","2025-07-18",{"date":168,"type":43},"2025-07-23",{"date":170,"type":43},"2024-10-31",{"date":172,"type":22},"2025-11-25",{"name":49,"class":50},1,""]