[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pneumonia-viral\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pneumonia-viral":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100448768","phase-2-phase-2a-multiple-ascending-dose-study-in-hospitalized-patients-with-pneumonia-100448768",false,"NCT05123755","Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.","A Randomized, Double-blind, Placebo-controlled, Phase 2a Multiple Ascending Dose Study to Examine the Safety, Tolerability and Efficacy of AV-001 Injection in Patients Hospitalized With Pneumonia Due To COVID-19 or Other Respiratory Infections.","Inclusion Criteria:\n\n* Able and willing to give signed informed consent\n* Patients hospitalized with a presumed diagnosis of pneumonia of \\\u003C 48 hours duration requiring supplemental oxygen therapy. Eligible patients include those hospitalized for a separate non-infectious reason who subsequently develop a presumed pneumonia;\n* Radiologic imaging (chest x-ray, CT scan, etc.) evidence of pulmonary involvement with new and persistent or progressive and persistent infiltrate, consolidation or cavitation.\n\nSigns and symptoms:\n\nAt least 1 of the following signs:\n\n* respiratory rate \\> 30 breaths\u002Fmin;\n* fever (\\> 38.0ºC or \\> 100.4o F);\n* leukopenia (≤ 4,000 WBC\u002Fmm3 or leukocytosis (≥ 12,000 WBC\u002Fmm3);\n* adults ≥ 70 years of age; altered mental status with no other recognized cause;\n\nAND at least 1 of the following symptoms:\n\n* New onset of purulent sputum or change in character of sputum or increased respiratory secretions;\n* New onset or worsening cough, or dyspnea, or tachypnea;\n* Rales or bronchial breath sounds;\n\n  * Female patients of reproductive potential must be on an effective contraceptive method\n\nExclusion Criteria:\n\n* Pregnant and\u002For lactating women\n* Patients included in any other interventional trial\n* Use of endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at screening\n* Any concurrent serious medical condition or concomitant medication that would preclude participation in the study including but not limited to:\n\n  * Septic shock as defined by systolic blood pressure (SBP) \\\u003C 90 mmHg or diastolic blood pressure (DBP) of \\\u003C 60 mmHg;\n  * Multiple organ failure;\n  * Are moribund irrespective of the provision of treatments;\n  * Any significant bleeding disorder or vasculitis;\n  * Any serious, nonhealing wound, peptic ulcer or bone fracture;\n  * Liver cirrhosis;\n  * History of a hypertensive crisis or hypertensive encephalopathy, or current, poorly controlled hypertension or hypotension;\n  * Severe renal insufficiency or end stage renal disease as determined by estimated glomerular filtration rate \\\u003C30mL\u002Fmin\u002F1.73m2;\n  * ARDS risk factors of aspiration pneumonia, non-cardiac shock, trauma, blood transfusion or drug overdose.\n* Any thromboembolic event within the past 3 months;\n* Symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia \\> class II as per New York Heart Association (NYHA) classification;\n* History of autonomic disorders or uncontrolled hypotension\n* Hypersensitivity to drug products containing polyethylene glycol (PEG)\n* Any other condition which the Principal Investigator feels may jeopardize the safety of the patient or the objectives of the study","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","A Phase 2a, randomized, double-blind, placebo-controlled, multiple ascending dose study in patients who are hospitalized with presumed pneumonia requiring supplemental oxygen therapy. The purpose of this study is to examine the safety, tolerability and efficacy of AV-001 Injection administration daily to the earlier of day 28 or EOT (day prior to hospital discharge). A total of 120 eligible patients (20 patients in each of cohort 1, 2 and 3 and 60 patients in cohort 4) will be recruited from up to 25 participating institutions\u002Fhospitals. Patients will be randomized in a 1:1 ratio to receive either AV-001 Injection or AV-001 placebo Injection, together with standard of care (SOC).",[26,27,28,29,30,31],"Acute Respiratory Distress Syndrome","Viral or Bacterial Infections","Pneumonia","Pneumonia, Viral","Respiratory Infection","COVID-19 Acute Respiratory Distress Syndrome","RECRUITING","2026-02-24",{"date":35,"type":36},"2026-02-27","ACTUAL",{"date":38,"type":36},"2021-12-20",{"date":40,"type":20},"2026-06",{"name":42,"class":43},"Vasomune Therapeutics, Inc.","INDUSTRY",5,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100526419","phase-3-acyclovir-in-ventilated-patients-with-pneumonia-and-hsv-1-in-bal-100526419","NCT06134492","Acyclovir in Ventilated Patients With Pneumonia and HSV-1 in BAL","Effect of Acyclovir Therapy on the Outcome of Ventilated Patients With Lower Respiratory Tract Infection and Detection of Herpes Simplex Virus in Bronchoalveolar Lavage","HerpMV","Inclusion Criteria:\n\n1. ≥ 18 years\n2. need for invasive or non-invasive respiratory support\n3. PCR HSV-1 detection in BAL (≥ 10\\^3 copies\u002Fml)\n4. Pneumonia (community or healthcare acquired, incl. ventilator-associated pneumonia)\n5. declaration of consent by the patient or legal representative\n\nExclusion Criteria:\n\n1. History of hypersensitivity to acyclovir or valacyclovir or other components of the investigational product.\n2. Pregnancy\u002FLactation\n3. Simultaneous participation in another interventional clinical trial\n4. Decision to withhold life-sustaining therapies\n5. Use of a virostatic agent (i.v. or p. os) with activity against herpes simplex (acyclovir, valacyclovir, famciclovir\u002Fpenciclovir, brivudine, cidofovir, foscarnet) for therapeutic or prophylactic reasons at the time of randomization.\n6. Solid organ transplantation, stem cell transplantation\n7. Neutropenia (absolute neutrophil count \\\u003C1500\u002Fμl (\\\u003C1.5 × 109 \u002Fl)\n8. Previous study participation in HerpMV",{"count":54,"type":20},616,[56],"PHASE3","Almost 90 out of 100 people carry herpes simplex viruses (HSV). Once a person has been infected with the herpes viruses, he or she can't get rid of them for the rest of her\u002Fhis life. For the most part, the viruses are in a dormant state. Only when the immune system is weakened, for example in the case of a serious illness or stress, are the viruses reactivated. They then mainly cause cold sores, which are harmless for healthy people and usually heal without therapy. However, especially in people with a weakened immune system, HSV can also cause serious infections, such as meningitis. In almost every second mechanically ventilated patient in intensive care who has pneumonia, HSV can be detected in the respiratory tract. This is caused by reactivation of the viruses as a result of the severe underlying disease and stress during intensive care therapy. Whether treatment of the herpes viruses (e.g. with acyclovir) is necessary in this situation and helps the patients to cure has not been clarified, especially as acyclovir can also cause side effects such as a deterioration in kidney function. Currently, the physicians decide to treat the herpes viruses in about half of the patients. Several studies have shown that patients for whom the physician decided to treat the viruses survived more often. However, all of these studies looked at the course of the disease only retrospectively and thus are subject to many biases (including physician selection of who receives treatment, missing data). A definitive conclusion as to whether herpesvirus therapy can be recommended cannot be drawn without doubt from these studies. Therefore, the investigators would like to investigate in a randomized controlled trial, i.e. patients are randomly assigned to the experimental (therapy of herpesviruses) or control group (no therapy of herpesviruses), the effect of therapy with acyclovir on survival in ventilated intensive care patients with lower respiratory tract infection (pneumonia) in whom a large amount of HSV was found in the respiratory tract. The goal of the study is to provide clarity on whether therapy will help patients recover.",[29,59,60,61,62],"Ventilator Associated Pneumonia","Community-acquired Pneumonia","Herpes Simplex","Hospital-acquired Pneumonia",[28,61,64,65],"Mechanical Ventilation","Aciclovir","2025-11-18",{"date":68,"type":36},"2025-11-21",{"date":70,"type":36},"2024-02-20",{"date":72,"type":20},"2026-12",{"name":74,"class":75},"Jena University Hospital","OTHER",28,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100554631","ai-based-system-for-assessing-suspected-viral-pneumonia-related-lung-changes-100554631","NCT06501599","AI-based System for Assessing Suspected Viral Pneumonia Related Lung Changes","Artificial Intelligence Based System for Assessing Suspected Viral Pneumonia Related Lung Changes According to Visual Pulmonary Lesion Grading System (CT 0-4): Retrospective Study","Inclusion Criteria:\n\n1. General\n\n   1. Patients over 18 years old;\n   2. Patients who underwent CT without contrast enhancement;\n   3. Patients who underwent a CT scan according to a standardized scanning protocol: 120 kilovolts, slice thickness max. 2 mm, rigid \"lung\" filter (kernel) reconstruction;\n   4. Patients whose studies should be of acceptable quality, performed with breath-holding, without technical artifacts, and respiratory and motor artifacts;\n   5. Patients whose studies must contain DICOM tags responsible for the orientation and position of the patient in the images during the study, as well as DICOM tags responsible for the size of the scans and image parameters;\n   6. Patients in whom the localization of changes is predominantly bilateral, in the basal and subpleural parts of the lungs, may be located peribronchial;\n2. For group Normal\n\n   a. Patients who do not contain COVID-19-related CT patterns;\n3. For groups Mild, Moderate, Severe, and Critical\n\n   1. Patients who contain COVID-19-related CT pattern: ground glass opacities (mild, moderate, and higher intensity);\n   2. Patients who contain COVID-19-related CT pattern: pulmonary consolidation;\n   3. Patients who contain COVID-19-related CT pattern: cobblestone infiltration of the lung parenchyma;\n   4. Patients who contain COVID-19-related CT pattern: hydrothorax;\n   5. Patients who contain a combination of one or more patterns.\n\nExclusion Criteria:\n\n* Patients whose studies contain images with unreported CT patterns;\n* Patients whose examinations do not conform to DICOM format;\n* Patients whose examinations do not contain imaging of the lung region\n* Patients whose examinations contain technical artifacts caused by malfunctions or features of CT scanners;\n* Patients whose examinations contain improper patient positioning;\n* Patients whose examinations contain studies with deleted DICOM tags responsible for scan size and image parameters;\n* Patients whose examinations contain metal artifacts on the patient's body and clothing;\n* Patients whose examinations contain the presence of other pathologic changes of lungs in patients - neoplastic, tuberculosis process, bacterial pneumonia, etc.;\n* Patients under 18 years old.",true,{"count":86,"type":20},563,"OBSERVATIONAL","The AI-based system designed to process chest computed tomography (CT) aims to 1) detect the presence of pathologic patterns associated with interstitial changes in pneumonia; 2) highlight areas on the images with the probable presence of pathologies; 3) provide the physician with the results of image processing, including quantitative indicators of suspected viral pneumonia related lung changes according to visual pulmonary lesion grading system (CT0-4).\n\nThe retrospective study aims to demonstrate the clinical validation of the AI-based system. Clinical validation measures (sensitivity, specificity, accuracy, and area under the ROC curve) will be determined to provide evidence about the clinical efficacy of the AI-based system.\n\nThe hypothesis is that the measures of clinical validation of the AI-based system differ by no more than 8% from those declared by the manufacturer.",[29,90],"COVID-19 Pneumonia",[92,93,94,95],"Artificial Intelligence","Machine Learning","Computed tomography","Chest CT","2024-07-18",{"date":98,"type":36},"2024-07-22",{"date":100,"type":36},"2024-06-03",{"date":102,"type":20},"2025-12-03",{"name":104,"class":75},"Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department",1]