[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-respiratory-distress-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-respiratory-distress-syndrome":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,89,0,25,[9,47,79,110,127,142,158,182,207,232,259,277,307,339,364,385,409,435,463,482,507,533,557,584,606],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100652427","serum-srage-cc16-and-syndecan-1-as-predictors-of-ards-and-mortality-after-severe-chest-trauma-100652427",false,"NCT07774338","Serum sRAGE, CC16, and Syndecan-1 as Predictors of ARDS and Mortality After Severe Chest Trauma","Early Admission Serum Soluble Receptor for Advanced Glycation End Products (sRAGE), Club Cell Protein-16 (CC16), and Syndecan-1 as Independent Predictors of Acute Respiratory Distress Syndrome and In-Hospital Mortality Following Severe Isolated Chest Trauma: A Prospective Cohort Study.","Inclusion Criteria:\n\n* Adult patients aged 18 - 60 years old.\n\n  * Patients with blunt or penetrating severe chest trauma.\n  * Chest Abbreviated Injury Scale (Chest AIS ≥3).\n  * Admission within 24 hours of injury.\n  * Patients admitted to the Trauma Unit or Trauma ICU.\n  * Written informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n* h. Age below 18 years or above 60 years old (to ensure a homogeneous adult study population and avoid age- related physiological differences).\n\n  * i. Hospital admission more than 24 hours after injury (to ensure early biomarker measurement before secondary inflammatory changes occur).\n  * j. Previous diagnosis of acute respiratory distress syndrome before admission (to ensure that ARDS outcomes are attributable to the index chest trauma).\n  * k. Pre-existing chronic interstitial lung disease (to avoid baseline pulmonary abnormalities that may influence biomarker levels and respiratory outcomes).\n  * l. Acute exacerbation of chronic obstructive pulmonary disease requiring hospitalization (to minimize confounding from pre-existing acute pulmonary inflammation).\n  * m. Active pulmonary infection before trauma (to exclude pre-existing pulmonary inflammation that may alter biomarker levels and increase the risk of ARDS independently of trauma).\n  * n. End-stage chronic liver disease (to avoid altered inflammatory responses and poor clinical outcomes unrelated to chest trauma).\n  * o. End-stage renal disease requiring dialysis (to avoid altered clearance of circulating biomarkers and independently increased mortality risk).\n  * p. Active malignancy receiving chemotherapy or radiotherapy (to exclude patients with cancer-related systemic inflammation and immunosuppression that may affect biomarker levels and outcomes).\n  * q. Pregnancy (because physiological changes during pregnancy may influence biomarker levels and respiratory function).\n  * r. Patients transferred from another hospital more than 24 hours after injury (to ensure standardized early clinical assessment and biomarker sampling within the predefined study period).\n  * s. Refusal to participate in the study (because informed consent is required for study enrollment).\n  * t. Connective tissue diseases\n  * u. Severe burns and major inhalational injury v. Immunosuppressive therapy\n  * w. Chronic systemic inflammatory diseases\n  * x. Severe obesity ( BMI\\>40), if relevant.\n  * y. Poly trauma with AIS\\> or = 3 outside the chest.","ALL","18 Years","60 Years",{"count":21,"type":22},85,"ESTIMATED","OBSERVATIONAL","This prospective cohort study aims to evaluate whether blood levels of soluble receptor for advanced glycation end products (sRAGE), Club Cell Protein-16 (CC16), and Syndecan-1 measured early after severe chest trauma can predict the development of acute respiratory distress syndrome (ARDS) and in-hospital mortality. Adult patients aged 18 years or older admitted with severe blunt or penetrating chest trauma will be enrolled. Clinical data, injury severity, laboratory findings, imaging results, and clinical outcomes will be recorded. Patients will be followed daily during the first 7 days after admission for the development of ARDS, and in-hospital mortality will be recorded until discharge or death. The findings may help identify patients at high risk of respiratory complications and poor outcomes after severe chest trauma.",[26,27],"Acute Respiratory Distress Syndrome","Chest Trauma",[29,30,31,32,33,34],"Severe chest trauma","Acute respiratory distress syndrome","sRANGE","CC16","Syndecan-1","Trauma biomarker","NOT_YET_RECRUITING","2026-08-17",{"date":38,"type":39},"2026-08-19","ACTUAL",{"date":41,"type":22},"2026-10",{"date":43,"type":22},"2028-12",{"name":45,"class":46},"Assiut University","OTHER",{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100500820","vascular-ards-recruitment-after-inhaled-nitric-oxide-100500820","NCT05801224","Vascular ARDS Recruitment After Inhaled Nitric Oxide","Regional Vascular Recruitment With Inhaled Nitric Oxide in Patients With ARDS","Inclusion Criteria:\n\n* Adult intubated and mechanically ventilated patients (≥ 18 years old) admitted to the intensive care unit (ICU)\n* ARDS diagnosis with mild to moderate severity by Berlin criteria1 (100 mmHg \\\u003C PaO2\u002FFiO2 \\\u003C= 300 mmHg)\n* Presence of an arterial line for blood gas measurement and blood pressure monitoring and of a central line for hypertonic saline injection\n\nExclusion Criteria:\n\n* Suspected pregnancy, pregnancy or less than six weeks postpartum\n* Younger than 18 years or older than 80 years\n* Baseline methemoglobin ≥ 5%\n* Subjects enrolled in another interventional research study\n* Presence of pneumothorax\n* Usage of any devices with electric current generation, such as a pacemaker or internal cardiac defibrillator\n* Preexisting chronic lung disease or pulmonary hypertension\n* Past medical history of lung malignancy or pneumonectomy, or lung transplant\n* Left ventricle ejection fraction \\\u003C20%\n* Hemodynamic instability is defined as:\n\n  * Persistent systolic blood pressure \\\u003C90 mmHg and\u002For \\>180 mmHg despite the use of vasopressor or vasodilators, or\n  * Requiring an increment in inotropic vasopressors over the past two hours just before enrollment: more than 15 mcg\u002Fmin for norepinephrine and dopamine, more than 10 mcg\u002Fmin in epinephrine, and more than 50 mcg\u002F min for phenylephrine.\n* Hypernatremia (serum sodium \\> 150 mEq\u002FL)\n* Patients cannot be enrolled for DECT if they have:\n\n  * History of allergic reaction to intravenous contrast\n  * Renal dysfunction on the day of the study (serum creatinine \\> 1.5 mg\u002FdL)","80 Years",{"count":56,"type":22},70,"INTERVENTIONAL",[59],"NA","Acute respiratory distress syndrome (ARDS) is when a person's lungs become inflamed, which can be caused by infection, trauma, surgery, blood transfusion, or burn. ARDS often leads to a situation where the person cannot breathe independently and needs machines' help. Once the lungs are inflamed, the small air sacs responsible for exchanging gases (i.e., ventilation) and the blood flow in the lungs (i.e., perfusion) can be affected. In the past, most research focused on studying ventilation physiology and how to help people breathe with machines. Less was done on perfusion because it requires imaging techniques such as computed tomography with intravenous contrast and radiation. One treatment option for low oxygen levels is inhaled nitric oxide (iNO), a gas that can dilate the lung blood vessels and improve oxygenation; however, it is not always clear whether this treatment will work.\n\nProne position has been used for several years in the care of ARDS patients and has been demonstrated to improve survival in more severe patients. It is not known how iNO and prone positioning interact in determining the distribution of pulmonary perfusion and whether their combine use can benefit ARDS patients.\n\nElectrical Impedance Tomography (EIT) is a bedside and accessible imaging technique that is radiation-free and non-invasive and can potentially detect changes in lung perfusion. EIT can perform multiple measurements; it is portable and accessible. This prospective interventional study aims to assess changes in regional blood perfusion in the lungs of patients with ARDS in response to iNO and to prone positioning utilizing EIT. The main questions it aims to answer are:\n\n1. If EIT can measure lung regional perfusion response to an iNO challenge of 20ppm for 15 minutes.\n2. If EIT can measure the lung regional perfusion responses to prone position, applied alone and in combination with iNO.\n3. If EIT is comparable to dual-energy computed tomography (DECT), the gold-standard method, in the detection of changes in regional lung perfusion due to iNO.\n4. If EIT can be an imaging marker to identify ARDS severity\n\nParticipants will be divided into three cohorts:\n\n1. Sub-Cohort 1 (n=60): Participants will be asked to be monitored by EIT before, during, and after the administration of iNO (20 ppm) for 15 minutes (OFF-ON-OFF) in the supine position\n2. Sub-Cohort 2 (N=10): Participants will be asked to be monitored by EIT before and during the administration of iNO (20 ppm) for 15 minutes (OFF-ON) in both the supine and in the prone position. The same subjects will be monitored also with DECT in the supine position and then after 30 minutes in the prone position (without NO administration).\n3. Sub-Cohort 3 (N=10): In this subset of Sub-Cohort 1, subjects will be asked to be monitored also with DECT (in addition to EIT) in the supine body position before iNO and after 15 minutes while receiving iNO.",[26,62],"Ventilation Perfusion Mismatch",[30,64,65,66,67],"Ventilation\u002Fperfusion mismatch","Electrical impedance tomography","Inhaled nitric oxide","Dual-energy computed tomography","RECRUITING","2026-08-14",{"date":71,"type":39},"2026-08-18",{"date":73,"type":39},"2026-07-10",{"date":75,"type":22},"2028-12-31",{"name":77,"class":46},"Massachusetts General Hospital",1,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":57,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"100570117","phase-2-just-breathe-breathing-life-into-innovative-therapies-for-ards-master-record-100570117","NCT06703073","JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)","Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)","Inclusion Criteria\n\nEach participant must meet all of the following criteria to be enrolled in this study:\n\n* Participant (or their Legally Authorized Representative (LAR)) provides informed consent and agrees to comply with protocol requirements\n* Participant is at least 18 years of age or older at the time of consent.\n* Participant with signs and symptoms of ARDS according to the Berlin definition of ARDS.\n\nNote that participants on noninvasive ventilation may be screened.\n\n* Participant of childbearing potential must agree to either abstinence or use at least one primary form of contraception, not including hormonal contraception, from the time of screening through Day 28. Additional cohort-specific requirements may apply\n* Participant agrees to not participate in another investigational interventional study while participating in this study (i.e., through Day 90).\n\nExclusion Criteria\n\nParticipants will be excluded from the study if any of the following apply:\n\n* Participant with ARDS or at risk of developing ARDS due to the following reasons: trauma, large volume aspiration, or transfusion.\n* Participant with pulmonary edema due to cardiogenic pulmonary edema\u002Ffluid overload or hypoxemia primarily attributable atelectasis, in the absence of a predisposing risk factor for ARDS.\n* Participant who demonstrates an improvement in oxygenation and ventilatory support 24 hours prior to or during screening up to randomization, such that per investigator clinical judgement, the participant is expected to have significant improvement in lung function over subsequent 24 hours regardless of additional interventions.\n* Participant is known to be pregnant, nursing, or with a positive (urine and\u002For serum test) pregnancy test.\n* Participant is anticipated to be transferred to another hospital which is not a study site within 72 hours.\n* Participant is not expected to survive for 72 hours.\n* Participant has been on invasive mechanical ventilation or ECMO for ARDS for more than 48 hours for ARDS at the time of consent.\n* Participant has an underlying clinical condition where, in the opinion of the Investigator and based on their clinical judgement, it would be extremely unlikely that the participant would come off ventilation\n* Participant has severe COPD requiring continuous long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for CPAP or bi-level positive airway pressure used solely for sleep-disordered breathing.\n* Participant has interstitial lung disease or idiopathic pulmonary fibrosis requiring continuous chronic home oxygen therapy.\n* Participant has NY Heart Association Class IV congestive heart failure.\n* Participant has a known allergy to any study medication or any of its excipients.\n* Participant is receiving systemic immunosuppressive therapy for solid organ or hematopoietic cancer or transplant anti-rejection medication therapy OR systemic immunosuppressive corticosteroids (prednisone ≥20 mg daily or equivalent). NOTE: Patients onreceiving chronic low dose immunosuppressive therapy may be enrolled(e.g., prednisone \\\u003C20 mg\u002Fday or equivalent) and patients on stable, long-term maintenance immunosuppression (e.g., tacrolimus, mycophenolate, orsirolimus) and patients receiving physiologic replacement and hormonal therapies for breast cancer (e.g., tamoxifen, letrozole) or prostate cancer (leuprolide, bicalutamide) for \\>60 days may be eligible at the investigator's discretion of the investigator in consultation with the medical monitor.\n* Participant is receiving ongoing cytotoxic chemotherapy (IV or oral), OR combination targeted\u002Fimmunotherapy regimens for cancer within the past 60 days. Note: Participants receiving non-myelosuppressive cancer therapy (e.g., hormonal therapy or selected targeted \u002F immunotherapy regimens) may be eligible if therapy has been stable ≥60 days; The use of hydroxyurea to manage patients with chronic myeloid leukemia, polycythemia vera, essential thrombocythemia or sickle cell disease is permitted.\n* Participant received treatment with an investigational immunomodulator or immunosuppressant drugs within 5 half-lives or 30 days (whichever is longer) before randomization.\n* Participant with concurrent infections or history of the following:\n\n  1. Known active tuberculosis,\n  2. Known active Hepatitis B, or\n  3. HIV and a CD4 count less than 50 or a detectable viral load of \\>200 copies\u002FmL HIV RNA.\n* Participant received treatment with any other investigational drugs within 30 days prior to consent.\n* Participant had a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 28 days of screening or inadequate wound healing secondary to major thoracoabdominal surgery at the time of screening.\n* Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.\n\nParticipant may have additional cohort-specific requirements.",{"count":87,"type":22},600,[89],"PHASE2","This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Participants will be randomized to receive either a placebo or one of the active treatments.\n\nThis record describes the default procedures and analyses for all cohorts. Each specific cohort may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in the corresponding intervention-specific records on clinicaltrials.gov listed below in the detailed description.",[92,93,94,26],"Acute Respiratory Distress Syndrome (ARDS)","ARDS","ARDS (Acute Respiratory Distress Syndrome)",[96,97,93,26,98],"BARDA","JUST BREATHE","Acute Respiratory Failure","2026-07-29",{"date":101,"type":39},"2026-07-31",{"date":103,"type":39},"2025-06-10",{"date":105,"type":22},"2028-09",{"name":107,"class":108},"PPD Development, LP","INDUSTRY",41,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":84,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":57,"phases":118,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":126,"locationsCount":109},"100570010","phase-2-just-breathe-breathing-life-into-innovative-therapies-for-ards--cohort-a-vilobelimab-100570010","NCT06701682","JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab","Inclusion Criteria:\n\nThe following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n* ARDS Severity of moderate or severe based on PaO2\u002FFiO2 or SpO2\u002FFiO2 assessment at the time of randomization\n\nExclusion Criteria:\n\nThe following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n* Participant with established cirrhosis and a modified Child-Pugh Score of 12 or greater",{"count":117,"type":22},200,[89],"This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.\n\nCohort A: Participants will be randomized to receive either a placebo or vilobelimab.\n\nThis record describes the default procedures and analyses for Cohort A. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.",[92,93,94,26],[96,97,93,26,98],{"date":101,"type":39},{"date":124,"type":39},"2025-06-21",{"date":105,"type":22},{"name":107,"class":108},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":84,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":57,"phases":134,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":140,"leadSponsor":141,"locationsCount":109},"100570009","phase-2-just-breathe-breathing-life-into-innovative-therapies-for-ards--cohort-b-paridiprubart-100570009","NCT06701669","JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart","Inclusion Criteria:\n\nThe following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073:\n\n* ARDS Severity of moderate or severe based on PaO2\u002FFiO2 or SpO2\u002FFiO2 assessment at the time of randomization.\n\nExclusion Criteria:\n\nThe following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n* Participant has a known allergy or known hypersensitivity to paridiprubart or its excipients, including polysorbate 80\n* Participant with established cirrhosis and a modified Child-Pugh Score of 12 or greater",{"count":117,"type":22},[89],"This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.\n\nCohort B: Participants will be randomized to receive either a placebo or paridiprubart.\n\nThis record describes the default procedures and analyses for Cohort B. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.",[92,93,94,26],[96,97,93,26,98],{"date":101,"type":39},{"date":103,"type":39},{"date":105,"type":22},{"name":107,"class":108},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":84,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":57,"phases":149,"briefSummary":150,"conditions":151,"keywords":152,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":157,"locationsCount":109},"100570008","phase-2-just-breathe-breathing-life-into-innovative-therapies-for-ards--cohort-c-bevacizumab-100570008","NCT06701656","JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab","Inclusion Criteria:\n\nThe following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n* ARDS Severity of mild, moderate or severe, based on PaO2\u002FFiO2 or SpO2\u002FFiO2 assessment at the time of randomization.\n\nExclusion Criteria:\n\nThe following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n* Participant has a known allergy or hypersensitivity to the active substance\u002Fexcipients, or Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies\n* Participant with established cirrhosis and a modified Child-Pugh Score of 7 or greater\n* Participant was dialysis-dependent prior to hospitalization. Participant must have a urine dipstick for proteinuria \\\u003C 2+\n* The hospitalized participant has a history or currently experiencing the following:\n\n  1. Participant must not have an international normalized ratio (INR) \\>1.5 and\u002For aPTT \\>1.5 × upper limit of normal (ULN) within 7 days prior to initiation of study treatment for participants not receiving anticoagulation. For participants on full dose oral or parenteral anticoagulants for therapeutic purposes the INR and\u002For activated partial thromboplastin time (aPTT) must be within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the participant on a stable dose of anticoagulants for ≥ 2 weeks prior to initiation of study treatment.\n  2. Participant with recent serious hemorrhage or history of recent hemoptysis \\> 2 episodes (defined as ≥2.5 mL of bright red blood per episode) within 1 month of screening.\n  3. Participant with inadequately controlled hypertension (defined as systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg). Antihypertensive therapy is permitted to achieve these parameters.\n  4. Participant with a history of hypertensive crisis or hypertensive encephalopathy.\n  5. Participant with a history of Grade ≥ 4 venous thromboembolisms.\n  6. Participant with significant vascular disease (eg, aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 3 months of study drug treatment.\n  7. Participant with history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months of study drug treatment.\n  8. Participant with serious, non-healing wound, active ulcer, or untreated bone fracture.\n  9. Participant with history or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (ie, in the absence of therapeutic anticoagulation).\n  10. Participant with clinically significant cardiovascular disease including cerebrovascular accident or myocardial infarction within previous 6 months, unstable angina, congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication.\n  11. Participant with a platelet count of \\\u003C75×109\u002FL.\n  12. Participant with current or recent (\\\u003C10 days prior to initiation of study treatment) use of aspirin (\\>325 mg\u002Fday) or clopidogrel (\\>75 mg\u002Fday).\n  13. Participant is receiving a direct anticoagulant (DOAC) such as dabigatran (Pradaxa®) and rivaroxaban (Xarelto®) without the availability of a reversal agent at the site.\n  14. Participant is receiving a DOAC such as betrixaban (Bevyxxa®) and edoxaban (Lixiana®) for which there is no approved reversal agent.\n  15. Participant has urine dipstick for proteinuria ≥ 2+",{"count":117,"type":22},[89],"This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.\n\nCohort C: Participants will be randomized to receive either a placebo or bevacizumab.\n\nThis record describes the default procedures and analyses for Cohort C. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.",[92,93,94,26],[96,97,93,26,98],{"date":101,"type":39},{"date":155,"type":39},"2025-10-28",{"date":105,"type":22},{"name":107,"class":108},{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":57,"phases":168,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":78},"100649935","comparison-of-different-peep-strategies-in-moderate-to-severe-ards-based-on-various-bedside-assessment-tools-100649935","NCT07741916","Comparison of Different PEEP Strategies in Moderate-to-Severe ARDS Based on Various Bedside Assessment Tools","Comparison of Different PEEP Strategies in Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS) Based on Various Bedside Assessment Tools","OPTI-PEEP","Inclusion Criteria:\n\n* Patients on invasive mechanical ventilation\n* With moderate-to-severe ARDS :\n\n  1. Bilateral findings on chest X-ray\n  2. PaO₂\u002FFiO₂ ratio \\\u003C200 with PEEP ≥+5 cmH₂O\n  3. No evidence of cardiogenic pulmonary overload\n* Patients without inspiratory effort (curare administration not required)\n* Patient already fitted with an esophageal pressure probe\n* Patient already fitted with a thoracic impedance belt\n* No objection from the patient or a family member to the processing of their clinical data\n\nExclusion Criteria:\n\n* Protected individuals, namely:\n\n  1. Individuals receiving enhanced protection, namely minors\n  2. Individuals deprived of their liberty by a judicial or administrative decision\n  3. Pregnant and breastfeeding women\n  4. Individuals residing in a health or social care facility\n  5. Adults under legal guardianship\n* Patients with a do-not-resuscitate order or a decision to limit care\n* Patients with a pacemaker or an implantable cardioverter-defibrillator\n* Acute cor pulmonale\n* Pneumothorax or ongoing pleural\u002Fthoracic drainage\n* Patients in the prone position\n* Hemodynamic instability\n\n  1. An increase of \\>30% in the norepinephrine dosage over the past 6 hours\n  2. Norepinephrine dosage \\> 0.5 µg\u002Fkg\u002Fmin\n* Patients on veno-venous ECMO",{"count":167,"type":22},45,[59],"Many patients admitted to the intensive care unit (ICU) for a severe lung disease called acute respiratory distress syndrome (ARDS) require mechanical ventilation and positive end-expiratory pressure (PEEP) to improve their oxygenation. Ventilator settings-and particularly the level of PEEP-are critical in the management of these patients. In fact, inappropriate ventilator settings can lead to a worsening of the patients' lung disease or compromise their hemodynamic status.\n\nPEEP is a pressure maintained by the ventilator during the patient's exhalation to keep the alveoli open throughout the respiratory cycle. When PEEP is increased, if many alveoli open, this is called alveolar recruitment, which is the expected beneficial effect. However, in some patients, increasing PEEP can cause already-open alveoli to become overdistended without opening new alveoli; this is known as pulmonary overdistension. This phenomenon of overdistension will worsen the patient's pulmonary condition and may also lead to hemodynamic deterioration. To date, numerous techniques have been proposed for determining the optimal PEP level (alveolar recruitment without pulmonary overdistension) in these patients, but none can be recommended as the gold standard. The objective of our study is therefore to compare the various existing methods for determining the optimal PEEP level, in order to determine whether these methods are interchangeable and which would be the best method to use to optimize the care of these patients.\n\nTo this end, the investigators plan to conduct a prospective, observational, multicenter study in the Intensive Care Units of the Nice University Hospital and the European Hospital of Marseille. Patients on mechanical ventilation for ARDS will be included in the study, and medical and laboratory data from the electronic medical records obtained during the various PEEP measurements to determine the optimal PEEP will be analyzed.",[26],[26,172],"positive end expiratory pression","2026-07-28",{"date":175,"type":39},"2026-08-03",{"date":177,"type":22},"2026-09",{"date":179,"type":22},"2030-01",{"name":181,"class":46},"Centre Hospitalier Universitaire de Nice",{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":57,"phases":191,"briefSummary":192,"conditions":193,"keywords":197,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100555581","phase-2-anti-cd14-treatment-with-ic14-in-hospitalized-ards-patients-100555581","NCT06513949","Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients","Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Anti-CD14 Treatment With a Recombinant Chimeric Monoclonal Antibody (IC14) in Hospitalized Patients With Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\nPatients may be included in the study only if they meet all the following criteria:\n\n1. Adult patients (18+) on mechanical ventilations with acute respiratory distress syndrome (ARDS) by Berlin Criteria (≤48 hours)\n\n   1. P:F ratio \\\u003C 300\n   2. Positive end-expiratory pressure (PEEP) ≥5 cm H2O\n   3. Bilateral opacities on chest x-ray or chest computerized tomography (CT)-- not fully explained by effusions, lobar\u002Flung collapse, or nodules\n   4. Respiratory failure not fully explained by cardiac failure or fluid overload\n   5. Within 1 week of known clinical insult or new or worsening respiratory symptoms\n\n   i. Common Risk Factors for ARDS: Pneumonia, aspiration, inhalation injury, pulmonary contusion, pulmonary vasculitis, drowning, non-pulmonary sepsis, major trauma, pancreatitis, severe burns, non-cardiogenic shock, drug overdose, multiple transfusions\n2. Patient or Legal authorized representative able to understand and give written informed consent\n\nExclusion Criteria:\n\nAn individual fulfilling any of the following criteria should be excluded from enrollment in the study:\n\n1. Significant pre-existing organ dysfunction prior to hospitalization\n\n   1. Lung: Currently receiving home oxygen therapy as documented in medical record\n   2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \\\u003C20% as documented in the medical record\n   3. Renal: End-stage renal disease requiring renal replacement therapy or estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin.\n   4. Liver: Severe chronic liver disease defined as Child-Pugh Class C or hepatic transaminases \\>5 times upper limit of normal\n   5. Hematologic: Baseline platelet count \\\u003C50,000\u002Fmm3\n2. Presence of co-existing infection, including, but not limited to:\n\n   1. HIV infection not virally suppressed and with pre-hospitalization CD4 counts ≤ 500 cell\u002Fmm3\n   2. Active tuberculosis or a history of inadequately treated tuberculosis\n   3. Active hepatitis B or hepatitis C viral infection\n3. Current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (Enbrel®), infliximab (Remicade®), adalimumab (Humira®), certolizumab (Cimzia®), golimumab (Simponi®), anakinra (Kineret®), rilonacept (Arcalyst®), tocilizumab (Actemra®), sarilumab (Kevzara®), siltuximab (Sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments\n4. Receiving comfort measures only\n5. Requiring \\>2 vasopressors\n6. Pregnant\n7. Prisoners\n8. History of hypersensitivity or idiosyncratic reaction to IC14\n9. Women who are currently breastfeeding\n10. Bronchoscopy safety exclusions\n\n    1. P:F \\\u003C100 on 100% FiO2\n    2. Mean pulmonary artery pressure \\> 55 mmHg\n    3. Marked cardiovascular instability (Mean arterial pressure \\\u003C55 mmHg with vasopressor support)\n    4. Intracranial pressure ≥20 mmHg\n    5. Acute ischemic heart disease (unstable angina or ST-elevation myocardial infarction or Type 1 non-ST-elevation myocardial infarction)\n    6. Supported on extracorporeal membrane oxygenation\n    7. Endotracheal tube \\\u003C6.5 mm",{"count":190,"type":22},56,[89],"Hospitalized patients with ARDS will be randomized to intravenous treatment with a monoclonal antibody against CD14, called IC14, or placebo. They will be followed for 28 days.\n\nThe primary outcome is the day 4 oxygenation index assessed as a continuous measure.",[26,194,195,196],"Adult Respiratory Distress Syndrome","Acute Lung Injury","Acute Lung Injury\u002FAcute Respiratory Distress Syndrome (ARDS)",[93,198],"IC14",{"date":99,"type":39},{"date":201,"type":39},"2026-06-17",{"date":203,"type":22},"2029-06-01",{"name":205,"class":108},"Implicit Bioscience",2,{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":214,"sex":17,"minAge":215,"maxAge":18,"enrollmentInfo":216,"targetDuration":4,"studyType":57,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":4},"100648852","ai-guided-mechanical-ventilation-in-children-a-randomized-controlled-trial-100648852","NCT07728136","AI-Guided Mechanical Ventilation in Children: A Randomized Controlled Trial","Randomized Controlled Study on Intelligent Optimization of Ventilator Parameters for Pediatric Patients Undergoing Mechanical Ventilation Based on Large Language Models","Inclusion Criteria:\n\n1. PICU patients aged 1 month to 18 years.\n2. Receiving invasive mechanical ventilation, expected to last ≥ 24 hours.\n3. Informed consent signed before enrollment.\n\nExclusion Criteria:\n\n1. Expected survival \\\u003C 24 hours\n2. Irreversible brain injury (GCS = 3 + absence of brainstem reflexes)\n3. Severe congenital cardiopulmonary malformations affecting ventilation assessment\n4. Pregnancy (must be ruled out in adolescent girls)\n5. Currently participating in other ventilation intervention trials\n6. Guardian refusal to participate",true,"1 Month",{"count":117,"type":22},[59],"This prospective, randomized controlled trial aims to evaluate whether an AI-driven decision support system can improve clinical outcomes for mechanically ventilated pediatric patients (aged 1 month to 18 years) in the PICU, compared to standard care. The primary question addressed is: Do patients whose ventilator parameter optimization decisions are guided by AI assistance achieve a greater number of ventilator-free days within 28 days compared to those managed with standard care by medical staff? Eligible pediatric patients requiring mechanical ventilation following tracheal intubation will be randomly assigned (1:1) to either the AI-guided intervention group or the standard care control group. In the intervention group, physicians will receive real-time, AI-generated recommendations for ventilator parameters to inform clinical adjustments. In contrast, the control group will be managed according to standard clinical protocols. This study seeks to assess whether AI-driven ventilator optimization can effectively improve clinical outcomes and shorten ventilation duration for pediatric patients in the PICU.",[26,220,221,222],"Pneumonia in Children","Respiratory Failure (Pediatric Patients)","Congenital Heart Disease in Children","2026-07-22",{"date":225,"type":39},"2026-07-27",{"date":227,"type":22},"2026-09-01",{"date":229,"type":22},"2027-12-31",{"name":231,"class":46},"Wu Rongzhou",{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":57,"phases":241,"briefSummary":242,"conditions":243,"keywords":244,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100648950","full-course-ecmo-strategy-for-moderate-to-severe-ards-100648950","NCT07726953","Full-Course ECMO Strategy for Moderate-to-Severe ARDS","Establishment and Evaluation of a Full-Course ECMO Management Strategy for Patients With Moderate-to-Severe ARDS","Inclusion Criteria:\n\n* 1\\. Age 18 years or older. 2. Diagnosed with moderate-to-severe acute respiratory distress syndrome according to the global definition of ARDS.\n\nExclusion Criteria:\n\n\\- 1. Patients with tracheostomy before screening. 2. Patients who have received lung transplantation or are receiving venovenous extracorporeal membrane oxygenation as a bridge to lung transplantation.\n\n3\\. Patients with cardiogenic shock requiring venoarterial ECMO or venoarterial-venous ECMO support.",{"count":240,"type":22},500,[59],"China faces major challenges in the ECMO management of patients with moderate-to-severe ARDS, including substantial heterogeneity in clinical practice, low weaning success rates, and high complication rates. A key underlying reason is the lack of a standardized full-course management pathway that is applicable to real-world clinical practice in China. This study focuses on the construction and evidence-based evaluation of a precision full-course ECMO management pathway for patients with moderate-to-severe ARDS, aiming to address fragmented care processes and delayed quality improvement.\n\nThe study includes three main components. First, multidisciplinary consensus and evidence-based findings will be integrated to develop a standardized management pathway covering the full chain of assessment, initiation, maintenance, weaning, and rehabilitation. Second, a nationwide multicenter real-world study with a before-and-after design will be conducted to systematically evaluate the clinical effectiveness of this pathway in reducing mortality and complications and improving patient outcomes. Third, a closed-loop dynamic optimization system based on \"pathway-data-feedback-improvement\" will be established. With the support of an intelligent data platform and multidisciplinary review mechanisms, the pathway will be continuously updated and refined.\n\nThrough this study, a reproducible, traceable, and evaluable full-course ECMO management strategy is expected to be established. The study will also build a national collaborative research network and support the development of living clinical guidance, promoting the transition of ECMO care in China from experience-based practice toward standardized, homogeneous, and intelligent management, and providing a key technical framework and practical model for improving critical care.",[26],[26,245,246,247,248,249],"Moderate-to-Severe ARDS","Extracorporeal Membrane Oxygenation","ECMO","VV-ECMO","ECMO Management Pathway","2026-07-21",{"date":225,"type":39},{"date":253,"type":39},"2026-06-16",{"date":255,"type":22},"2030-02-28",{"name":257,"class":46},"Southeast University, China",39,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":78},"100615215","validation-and-precision-treatment-of-inflammatory-subphenotypes-in-acute-respiratory-distress-syndrome-a-multicenter-cohort-study-100615215","NCT07289711","Validation and Precision Treatment of Inflammatory Subphenotypes in Acute Respiratory Distress Syndrome: A Multicenter Cohort Study","VATIC","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. ARDS with new Global definition.\n3. Onset of ARDS within 72 hours.\n\nExclusion Criteria:\n\n1. Refusal of informed consent by the patient's legally authorized representative.\n2. Patients expected to die within 24 hours\n3. Receiving extracorporeal membrane oxygenation at the time of recruitment",{"count":240,"type":22},"Acute respiratory distress syndrome (ARDS) is a common and life-threatening condition in intensive care units, characterized by substantial biological and clinical heterogeneity. Differences in patients' inflammatory responses, baseline immune function, and organ failure patterns contribute to variability in ARDS severity, treatment response, and clinical outcomes. Precision classification of ARDS based on biological and inflammatory characteristics may therefore be essential for improving patient outcomes. Previous analyses of randomized clinical trials have identified two reproducible inflammatory subphenotypes-\"hyperinflammatory\" and \"hypoinflammatory\"-which differ in organ dysfunction profiles, clinical trajectories, and responses to treatments such as fluid management strategies, corticosteroids, and ventilatory interventions. However, key uncertainties remain, including whether these inflammatory subphenotypes can be validated in Chinese ARDS populations, how various bedside prediction models perform in identifying these subphenotypes, and whether model-based subphenotype identification can guide individualized treatment decisions. This multicenter cohort study aims to: (1) validate inflammatory subphenotypes of ARDS using latent class analysis; (2) compare the predictive performance of existing bedside models for subphenotype identification; and (3) assess whether subphenotype assignment based on prediction models can guide individualized treatment strategies, including fluid management, PEEP titration, and corticosteroid use. In addition to these primary aims, the study may include other exploratory objectives, such as evaluating subphenotype stability over time, characterizing biological pathways associated with subphenotypes, and assessing additional treatment-response patterns to support future precision ARDS management strategies.",[26],"2026-07-09",{"date":271,"type":39},"2026-07-13",{"date":273,"type":39},"2025-12-29",{"date":275,"type":22},"2026-12-31",{"name":257,"class":46},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":57,"phases":285,"briefSummary":286,"conditions":287,"keywords":292,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":78},"100638113","height-measurement-procedures-influence-the-risk-of-ventilator-induced-lung-injury-in-ards-100638113","NCT07595926","Height Measurement Procedures Influence the Risk of Ventilator-induced Lung Injury in ARDS","SIZE-ARDS","Inclusion Criteria:\n\n* Adult patient\n* Mechanical ventilation on volumetric mode\n* Sedated and curarized patient\n* Diagnosis of ARDS according to the Berlin criteria\n* Diagnosis of ARDS \\\u003C 48 hours\n* Signed informed consent\n* Affiliation with a social security or health insurance scheme\n\nExclusion Criteria:\n\n* Patient opposing the use of his\u002Fher data for research purposes.\n* Contraindication to placement of an esophageal balloon catheter (e.g., esophageal fistula, esophageal varices).\n* Contraindication to strict supine positioning for height measurement (e.g., proven or suspected intracranial hypertension with intracranial pressure \\>18 mmHg).\n* Impossibility of measuring height with the reference method (stadiometer) due to deformity or amputation of both lower limbs.\n* Patient under guardianship or curatorship, or deprived of liberty.\n* Pregnant or postpartum patient, or patient currently breastfeeding.",{"count":258,"type":22},[59],"Acute respiratory distress syndrome is characterized by heterogeneous lung injury, with dependent regions often collapsed and non-dependent regions relatively well-aerated, forming the so called \"baby lung.\" Mechanical ventilation, while essential, can induce additional lung injury (VILI) via overdistension (baro\u002Fvolutrauma) or repetitive alveolar collapse (atelectrauma). Protective ventilation strategies with low tidal volumes (VT 6-8 mL\u002Fkg predicted body weight, PBW) reduce mortality, but their efficacy relies on accurate PBW estimation, which is derived from patient height. In critical care, height measurement is often challenging, and common methods such as visual estimation or tape measurement can be inaccurate, leading to inappropriate VT settings and increased risk of lung stress and VILI. Alternative methods, including heel-to-knee distance and laser measurement, may offer more precise PBW estimation, yet their impact on lung mechanics in ARDS remains unexplored. This study addresses the knowledge gap by evaluating whether differences in height measurement methods significantly affect lung stress, tidal volume distribution, and ventilatory mechanics in ARDS patients.\n\nPatients' heights will be measured using five methods (stadiometer, visual, tape, laser, heel-to knee). Corresponding PBW and tidal volumes (VT = 6 mL\u002Fkg PBW) will be calculated and applied in randomized order, each for 30 minutes. Lung stress, ventilatory mechanics, gas exchange, and regional ventilation distribution will be assessed for each VT setting, preceded by a short alveolar recruitment maneuver. During the study, continuous monitoring of hemodynamics and oxygenation will be performed.\n\nVentilatory parameters including plateau pressure, driving pressure, and transpulmonary pressures will be recorded. Electrical impedance tomography will assess regional tidal volume distribution. Each patient's participation is limited to approximately two hours with no further follow-up.",[26,288,289,290,291],"Ventilator-Induced Lung Injury","Tidal Volume","Predicted Body Weight","Height",[293,294,295,296,297],"acute respiratory distress syndrome","ventilator-induced lung injury","tidal volume","predicted body weight","height","2026-07-02",{"date":300,"type":39},"2026-07-06",{"date":302,"type":39},"2026-05-20",{"date":304,"type":22},"2028-05",{"name":306,"class":46},"Centre Hospitalier Universitaire, Amiens",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":57,"phases":317,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":338},"100521200","phase-3-precision-ventilation-vs-standard-care-for-acute-respiratory-distress-syndrome-100521200","NCT06066502","Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome","PREcision VENTilation to Attenuate Ventilator-Induced Lung Injury: A Phase 3 Multicenter Randomized Clinical Trial","PREVENT VILI","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Ventilator-dependent ARDS, with all of the following (a-e):\n\n   1. Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 8 cm H2O or FiO2 ≥ 0.5\n   2. Hypoxemia as characterized by: • If arterial blood gas (ABG) available: the partial pressure of oxygen in the arterial blood (PaO2)\u002FFiO2 ≤ 300 mm Hg, or, • if ABG not available OR overt clinical deterioration in oxygenation since last ABG: SpO2\u002FFiO2 ≤ 316 with SpO2 ≤ 97% (both conditions) on two representative assessments between 1 to 6 hours apart. • If patient is positioned prone or receiving inhaled pulmonary vasodilator at time of screening:\n\n      Qualifying PaO2\u002FFiO2 or SpO2\u002FFiO2 (as defined above) that was recorded within the 6 hours immediately prior to initiating either of these therapies may be used for eligibility determination. • If PEEP has been increased by \\> 5 cm H2O within the last 12 hours immediately prior to screening:\n\n      Qualifying PaO2\u002FFiO2 or SpO2\u002FFiO2 (as defined above) prior to PEEP increase may be used for eligibility determination if recorded within this 12-hour window.\n   3. Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules\n   4. Respiratory failure not fully explained by heart failure or fluid overload\n   5. Onset within 1 week of clinical insult or new\u002Fworsening symptoms\n3. Early in ARDS course\n\n   * Full criteria for ARDS (#2 above) first met within previous 3 days\n   * Current invasive ventilation episode not more than 4 days duration\n   * Current severe hypoxemic episode (receipt of invasive ventilation, noninvasive ventilation, or high-flow nasal cannula) not more than 10 days duration\n\nExclusion Criteria:\n\n1. Esophageal manometry already in use clinically\n2. Severe brain injury: including suspected elevated intracranial pressure, cerebral edema, or Glasgow coma score (GCS) ≤ 8 directly caused by severe brain injury (e.g., ischemia or hemorrhage)\n3. Gross barotrauma or chest tube inserted to treat barotrauma (note: chest tube inserted strictly for drainage of pleural effusion is not an exclusion)\n4. Esophageal pathology that, in judgement of the site investigator, significantly increases risk of esophageal catheter placement, including high-risk esophageal varices, recent oropharyngeal or gastroesophageal surgery; or past esophagectomy\n5. Ongoing severe coagulopathy (platelet \\\u003C 5000\u002FμL or INR \\> 4)\n6. Extracorporeal membrane oxygenation (ECMO) or CO2 removal (ECCO2R)\n7. Neuromuscular disease that impairs spontaneous breathing (including but not limited to amyotrophic lateral sclerosis, Guillain-Barré syndrome, spinal cord injury at C5 or above)\n8. Any of the following severe chronic lung diseases: cystic fibrosis, acute bronchiectasis exacerbation, acute exacerbation of a chronic interstitial lung disease (ILD), chronic pulmonary hypertension (PH) on PH-targeted vasoactive medication, or lung transplant\n9. End-stage chronic cirrhosis with Child-Pugh Class C (Section 12.3)\n10. ICU admission for burn injury\n11. Current ICU stay \\> 2 weeks or acute care hospital stay \\> 4 weeks\n12. Moribund patient not expected to survive 24 hours as assessed by the study physician; if cardiopulmonary resuscitation (CPR) was provided, assessment for moribund status must occur at least 6 hours after CPR was completed\n13. Current limitation on life-sustaining care (other than do-not-resuscitate), or expectation by clinical team that a limitation on life-sustained care will be adopted within next 24 hours.\n14. Treating clinician refusal or unwilling to use protocol-specified ventilator settings\u002Fmodes\n15. Prisoner\n16. Previous enrollment in this trial",{"count":316,"type":22},1100,[318],"PHASE3","The goal of this interventional study is to compare standard mechanical ventilation to a lung-stress oriented ventilation strategy in patients with Acute Respiratory Distress Syndrome (ARDS). Participants will be ventilated according to one of two different strategies. The main question the study hopes to answer is whether the personalized ventilation strategy helps improve survival.",[26,321],"Respiratory Failure",[323,324,325,326,327,328],"critical care","critical illness","esophageal manometry","transpulmonary pressure","mechanical ventilation","lung stress","2026-06-25",{"date":331,"type":39},"2026-06-29",{"date":333,"type":39},"2024-06-24",{"date":335,"type":22},"2030-12-31",{"name":337,"class":46},"Beth Israel Deaconess Medical Center",33,{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":57,"phases":347,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":56},"100512092","phase-2-rhu-pgsn-for-acute-respiratory-distress-syndrome-ards-100512092","NCT05947955","Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)","A Phase 2 Randomized Double-blind Placebo-controlled Study To Evaluate The Efficacy And Safety Of Adjunctive Recombinant Human Plasma Gelsolin With Standard Care For Moderate-to-Severe ARDS Due To Pneumonia Or Other Infections","Inclusion Criteria:\n\n1. Infection followed within a week of documented bilateral infiltrates\u002Fopacities consistent with ARDS, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist\n\n   * Investigator or designee to note radiologic findings in the electronic case report form (eCRF)\n   * Radiology report and conclusion should be summarized in the eCRF\n   * A digital copy of the radiograph uploaded and saved for review\n2. Acute hypoxemic respiratory failure (moderate-to-severe ARDS) for ≤48 hours associated with suspected or confirmed infection (moderate-to-severe ARDS defined by the ratio of arterial pressure of O2 to the fraction of inspired O2 ≤150). Eligible subjects will be intubated for mechanical ventilation, receiving noninvasive ventilation by continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or on HFNO at least 30 L\u002Fmin of 50% or greater inspired O2. Although it is expected that most eligible subjects will be receiving positive end-expiratory pressure (PEEP) or CPAP ≥5 cm H2O consistent with the original Berlin definition (ARDS Definition Task Force 2012), these measures will not be mandated as entry criteria.\n3. Age ≥18 years\n4. Informed consent obtained from subject\u002Fnext of kin\u002Flegal proxy\n5. Clear or convincing evidence of a precipitating infection during the 7 days preceding the diagnosis of ARDS in the judgement of the screening or primary care team\n6. During the course of the study starting at screening and for at least 3 months after their final study treatment:\n\n   1. Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth control methods\n   2. Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner\n   3. All subjects must agree not to donate sperm or eggs\n\nExclusion Criteria:\n\n1. Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, atelectasis, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis are materially contributing to the clinical or radiological findings bas assessed by the care team or Investigator; an echocardiogram is strongly recommended as part of standard care to exclude a significant contribution of systolic or diastolic heart failure and volume overload.\n2. Presence of systemic fungal, yeast, parasitic, or mycobacterial infection\n3. Current or planned receipt of extracorporeal membrane oxygenation (ECMO)\n4. Pregnant or lactating women\n5. Previous splenectomy\n6. Any vaccination in the previous 30 days\n7. Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days\n8. Known allergy to study drug or excipients\n9. Weight \\>125 kg\n10. Active underlying cancer or treatment with systemic chemotherapy or radiation therapy during the last 60 days or likely to require similar treatments during the ensuing 6 months\n11. Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease\n12. Chronic mechanical ventilation or dialysis\n13. Unsuitable for study participation, in the opinion of the Investigator, because of chronic, severe, end-stage, or life-limiting underlying disease unrelated to current infection likely to interfere with management and assessment of ARDS, only comfort or limited (non-aggressive) care is to be given, or life expectancy \\\u003C6 months unrelated to acute infection in the opinion of the Investigator.",{"count":87,"type":22},[89],"BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN plus standard of care (SOC) in subjects with moderate-to-severe ARDS (P\u002FF ratio ≤150) due to pneumonia or other infections. Potential subjects hospitalized with pneumonia or other infections are to be screened within 24 hours of diagnosis of ARDS.",[26,350],"Infections",[352,353,354],"moderate to severe ARDS","respiratory failure","rhu-pGSN","2026-06-12",{"date":357,"type":39},"2026-06-15",{"date":359,"type":39},"2024-10-03",{"date":361,"type":22},"2027-03-01",{"name":363,"class":108},"BioAegis Therapeutics Inc.",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":57,"phases":374,"briefSummary":376,"conditions":377,"keywords":378,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":382,"leadSponsor":383,"locationsCount":4},"100642635","phase-1-r-3750-in-patients-with-late-stage-acute-respiratory-distress-syndrome-ards-100642635","NCT07646028","R-3750 in Patients With Late-Stage Acute Respiratory Distress Syndrome (ARDS)","A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunomodulatory Effects of R-3750 in Patients With Late-Stage Acute Respiratory Distress Syndrome (ARDS)","R-3750 ARDS","Inclusion Criteria:\n\n* Age ≥18 years at the time of consent.\n* Acute Respiratory Distress Syndrome (ARDS) meeting the contemporary clinical definition including all of the following occurring within a 24-hour interval:\n* Hypoxemia defined as PaO2\u002FFiO2 ≤300 mmHg, or SpO2\u002FFiO2 ≤315 if SpO2 is ≤97%;\n* Bilateral pulmonary infiltrates\u002Fopacities on chest imaging consistent with pulmonary edema or fibroproliferative lung injury and not fully explained by pleural effusions, lobar collapse, or atelectasis;\n* Requirement for positive pressure respiratory support, including invasive mechanical ventilation via endotracheal tube;\n* Respiratory failure not fully explained by left atrial hypertension or cardiogenic pulmonary edema; if measured, pulmonary artery wedge pressure should be ≤18 mmHg.\n* Late-stage, non-resolving ARDS, defined as:\n* At least 7 days and no more than 28 days since ARDS onset at the time of enrollment; and\n* Persistent bilateral infiltrates since ARDS onset; and\n* Continued need for substantial respiratory support since ARDS onset.\n* On the day of enrollment, ongoing respiratory impairment demonstrated by:\n* PaO2\u002FFiO2 ≤300 mmHg, or\n* SpO2\u002FFiO2 ≤315 if SpO2 is ≤97%.\n* Subject is receiving invasive mechanical ventilation, or other protocol-defined intensive respiratory support as approved by the Sponsor\u002FMedical Monitor.\n* The treating team considers the subject an appropriate candidate for enteral administration of study drug, including by nasogastric (NG), orogastric (OG), or other enteral tube, and there is an intention to provide enteral nutrition or medication administration through the gastrointestinal tract.\n* For subjects unable to provide consent, legally authorized representative (LAR) consent is obtainable in accordance with local regulations and Institutional Review Board (IRB)\u002FEthics Committee requirements.\n* The investigator judges that the subject is likely to remain under protocol-compatible management and follow-up for the duration of the treatment and key follow-up period.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* More than 28 days since onset of ARDS at the time of enrollment.\n* ARDS that is clearly resolving rapidly, in the judgment of the investigator, such that enrollment in a 28-day rescue-therapy study is not clinically appropriate.\n* Pregnancy or breastfeeding.\n* Participation in another interventional investigational drug or biologic study within 30 days prior to enrollment, or within 5 half-lives of the investigational product, whichever is longer, unless approved by the Sponsor and Medical Monitor.\n* Extracorporeal support for gas exchange at the time of study entry, including ECMO.\n* Inability to use the gastrointestinal tract for study drug administration, including but not limited to:\n\n  * Continuous gastric suction\u002Fdrainage that would preclude dosing,\n  * Bowel discontinuity preventing enteral delivery,\n  * Open abdomen,\n  * Dependence on total parenteral nutrition with no enteral access,\n  * Other conditions that, in the investigator's judgment, make enteral dosing infeasible.\n* Known or suspected bowel ischemia, gastrointestinal perforation, uncontrolled GI bleeding, or other severe gastrointestinal disorder that would substantially increase risk from enteral dosing.\n* Not committed to full supportive care, with the exception that subjects with a do-not-resuscitate order may be eligible if all other indicated intensive supportive treatments are being provided.\n* AIDS by CDC criteria, including documented AIDS-defining illness or CD4 count \\\u003C200 cells\u002Fmm³, if known.\n* Severe immunosuppression, including any of the following:\n* Cytotoxic chemotherapy within 3 weeks prior to enrollment,\n* High-dose corticosteroid exposure defined as cumulative prednisone ≥300 mg equivalent within 21 days prior to enrollment,\n* Ongoing systemic corticosteroid therapy \\>15 mg\u002Fday prednisone equivalent within 7 days prior to enrollment, unless justified as part of standard ARDS care and approved by the Medical Monitor,\n* Other severe acquired or iatrogenic immunodeficiency considered clinically significant by the investigator.\n* Active uncontrolled infection outside the lung that, in the judgment of the investigator, would confound safety assessment or increase subject risk.\n* Severe chronic respiratory disease likely to confound ARDS assessment or outcomes, including:\n* Advanced COPD requiring chronic home oxygen,\n* Clinically significant pulmonary fibrosis or interstitial lung disease,\n* Other severe chronic lung, chest wall, or neuromuscular disorders causing chronic respiratory failure.\n* Diffuse alveolar hemorrhage due to vasculitis.\n* Malignancy or other irreversible chronic condition for which estimated 6-month mortality is ≥50%, in the investigator's judgment.\n* Morbid obesity or body habitus that would substantially impair protocol assessments or ventilatory interpretation, if deemed clinically significant by the investigator.\n* Any condition that, in the opinion of the investigator or Medical Monitor, would make participation unsafe, interfere with interpretation of study results, or be inconsistent with study objectives.",{"count":373,"type":22},20,[375],"PHASE1","The goal of this clinical trial is to learn if R-3750 is safe in \\[in patients with late-stage, non-resolving Acute Respiratory Distress Syndrome (ARDS) . The main question\\[s\\] it aims to answer are:\n\n1. the favorable safety profile\n2. clinical improvement that includes reduced ventilator dependence and improved lung function.\n\nParticipants will be given oral capsules daily and\u002For enteral nasogastric or orogastric (NG\u002FOG tube) if necessary.",[26],[93,26],"2026-06-09",{"date":355,"type":39},{"date":227,"type":22},{"date":75,"type":22},{"name":384,"class":108},"Rise Therapeutics LLC",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":17,"minAge":393,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":57,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":78},"100517176","phase-2-volatile-sedation-for-patients-with-the-acute-respiratory-distress-syndrome-100517176","NCT06014138","Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome","Effect of Volatile Sedation on Spontaneous Breathing During Mechanical Ventilation for Patients With the Acute Respiratory Distress Syndrome","ISO-DRIVE","Inclusion Criteria:\n\n* Adult patients admitted to the Intensive Care Unit (ICU)\n* ARDS\n* Invasive mechanical ventilation (IMV)\n* Spontaneous breathing in pressures support mode (PSV) for less than or equal to 48 hours\n* Sedated with intravenous sedation (ie. propofol and \u002F or midazolam and fentanyl or alternate short acting opioid)\n* Anticipated to remain on IMV and PSV and with a stable sedation score for a further 24 hours without planned sedation interruption \u002F spontaneous breathing trial or other significant change in the level of ventilator support\n* Not receiving \u002F anticipated to receive paralysis\n* In supine position\n\nExclusion Criteria:\n\n* Personal or family history of malignant hyperpyrexia\n* Known or suspected elevated intracranial pressure\n* High dose vasopressors (ie. Noradrenaline \\> 0.3mcg\u002Fkg\u002Fmin or equivalent)\n* Contra-indication to oesophageal balloon (i.e. oesophageal \u002F upper gastro-intestinal pathology)\n* Pregnancy\n* High dose oral sedatives (e.g. benzodiazepines) or opioids (e.g. oxycodone \u002F oral morphine) which may affect respiratory drive","17 Years",{"count":373,"type":22},[89,318],"This study will investigate how different types of routine sedation may affect patient's breathing whilst on a ventilator in the Intensive Care Unit (ICU). There are different approaches to sedation which may have advantages and disadvantages. During the study patients will receive both intravenous and inhaled volatile sedation (similar to anaesthetic 'gases' used for general anaesthesia) and the drive to breath, breathing efforts and function of the lung will be assessed.",[26,398,399],"Mechanical Ventilation Complication","Sedation Complication","2026-06-03",{"date":402,"type":39},"2026-06-04",{"date":404,"type":39},"2023-11-01",{"date":406,"type":22},"2027-07-31",{"name":408,"class":46},"Guy's and St Thomas' NHS Foundation Trust",{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":57,"phases":419,"briefSummary":420,"conditions":421,"keywords":423,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":78},"100632276","phase-2-corticosteroids-in-hyperinflammatory-phenotype-of-critical-illness-100632276","NCT07511582","Corticosteroids in Hyperinflammatory Phenotype of Critical Illness","Efficacy, Safety, and Tolerability of Methylprednisolone in Critically Ill Patients With the Hyperinflammatory Phenotype: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Trial","CHIP","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n1. Age ≥18 years.\n2. Diagnosis of acute respiratory distress syndrome (ARDS) or sepsis.\n\nARDS will be defined according to standard criteria:\n\n1. acute onset within 1 week of a known clinical insult or new\u002Fworsening respiratory symptoms;\n2. bilateral pulmonary opacities on chest imaging (X-ray or CT) or bilateral B-lines and\u002For consolidation on lung ultrasound, not fully explained by effusion, atelectasis, or nodules;\n3. respiratory failure not fully explained by cardiac failure or fluid overload;\n4. hypoxemia defined as PaO₂\u002FFiO₂ ≤300 mmHg or SpO₂\u002FFiO₂ ≤315 (with SpO₂ ≤97%) under a minimum positive end-expiratory pressure (PEEP) of 5 cmH₂O.\n\nSepsis will be defined according to the Sepsis-3 criteria as suspected or confirmed infection with an acute increase in SOFA score ≥2 points, assuming a baseline SOFA score of 0 in patients without known prior organ dysfunction.\n\nSepsis-associated ARDS will be defined as ARDS occurring in patients with sepsis.\n\n3\\. Receiving invasive mechanical ventilation. 4. Admission to the intensive care unit (ICU). 5. Hyperinflammatory phenotype, defined as a predicted probability ≥0.5 using a validated AI clinical classifier based on clinical data.\n\n6\\. Randomization within 72 hours of ARDS or sepsis onset. 7. Provision of written informed consent by the patient or their legally authorized representative.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Requirement for high-dose vasopressor support, defined as norepinephrine ≥0.5 μg\u002Fkg\u002Fmin or epinephrine ≥0.25 μg\u002Fkg\u002Fmin.\n2. Post-cardiac surgery patients (e.g., coronary artery bypass grafting or valve replacement).\n3. Conditions requiring systemic corticosteroid therapy exceeding 1 mg\u002Fkg methylprednisolone or an equivalent dose (e.g., acute asthma exacerbation, acute exacerbation of chronic obstructive pulmonary disease, or autoimmune diseases).\n4. Long-term systemic corticosteroid use within the past 6 months.\n5. Pregnancy or lactation.\n6. Brain death.\n7. Advanced malignancy or other end-stage disease with an expected survival of less than 6 months, or anticipated death within 24 hours.\n8. Known hypersensitivity to methylprednisolone, including but not limited to urticaria, eczema, angioedema, bronchospasm, or anaphylaxis.\n9. History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n10. Active life-threatening fungal infection or tuberculosis.\n11. Neuromuscular disorders affecting spontaneous respiration.\n12. Severe inherited or acquired immunodeficiency (e.g., human immunodeficiency virus infection, chronic granulomatous disease, or severe combined immunodeficiency).\n13. Do-not-resuscitate (DNR) orders or withdrawal of life-sustaining treatment.\n14. Concurrent participation in another interventional clinical trial.\n15. Any other condition that, in the opinion of the treating physician or investigator, would make participation in the study inappropriate.",{"count":418,"type":22},150,[89],"The goal of this clinical trial is to learn whether methylprednisolone improves outcomes in critically ill patients with a hyperinflammatory phenotype. It will also evaluate the safety of methylprednisolone at different doses.\n\nThe main questions it aims to answer are:\n\n* Does methylprednisolone improve organ function compared with placebo?\n* Does methylprednisolone reduce the risk of mortality within 30 days?\n\nResearchers will compare high-dose methylprednisolone (160mg\u002Fd), low-dose methylprednisolone (80mg\u002Fd), and placebo (normal saline) to evaluate effectiveness and safety.\n\nParticipants will:\n\n* Receive high-dose methylprednisolone, low-dose methylprednisolone, or placebo every 12 hours for the first 3 days\n* Be reassessed on Day 4 based on their inflammatory status If the hyperinflammatory phenotype persists, the treatment dose will be reduced by half and continued until Day 7 or ICU discharge, whichever occurs first If the patient transitions to a hypoinflammatory phenotype, the study treatment will be discontinued\n* Be monitored daily in the intensive care unit for organ function, inflammatory status, and need for organ support\n* Be followed for up to 30 days after randomization to assess survival and recovery",[422,26],"Sepsis",[424,425,422,30],"Corticosteroids","Hyperinflammatory phenotype","2026-05-21",{"date":428,"type":39},"2026-05-26",{"date":430,"type":39},"2026-04-15",{"date":432,"type":22},"2028-06-01",{"name":434,"class":46},"Bin Du",{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":57,"phases":445,"briefSummary":446,"conditions":447,"keywords":448,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":462},"100581770","effect-of-continuous-prolonged-prone-position-versus-intermittent-daily-prone-position-in-ards-100581770","NCT06854627","Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position in ARDS","Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position on Mortality in ARDS Patients: A Multicenter Randomized Controlled Trial","ePRONE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Endotracheal intubation and mechanical ventilation for less than 72 hours\n* Moderate-severe ARDS defined as:\n\n  1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms\n  2. Bilateral infiltrates not fully explained by effusions, lobar\u002Flung collapse, or nodules\n  3. Respiratory failure not fully explained by cardiac failure or fluid overload\n  4. PaO2\u002FFiO2 \\\u003C 150 mmHg in supine position\n* Prone positioning has been indicated by the attending physician, OR has already been initiated within the last 16 hours\n\nExclusion Criteria:\n\n* Contraindications for prone positioning such as intracranial pressure \\> 20 mmHg, massive hemoptysis, recent tracheal surgery or sternotomy or abdominal surgery with an open wound, recent facial trauma or facial surgery, unstable spine, femur, or pelvic fractures, or a single anterior chest tube with air leaks\n* Patient on extracorporeal membrane oxygenation (ECMO) before randomization\n* Chronic respiratory failure requiring oxygen therapy or non-invasive ventilation (NIV)\n* Known pregnancy\n* Anticipating withdrawal of life support or shift to palliative care",{"count":444,"type":22},780,[59],"Prone position (placing the patient on his abdomen) has been shown to be an effective intervention to decrease mortality in adults connected to mechanical ventilation for moderate to severe Acute Respiratory Distress Syndrome (ARDS). Patients may require one or more sessions of prone position. However, the optimal duration of prone sessions is unknown. The goal of this clinical trial is to learn if applying prone position in prolonged sessions (\\> 48 hours - prolonged prone position) is more effective than applying it in daily sessions (16 to 24 hours - intermittent prone position). The trial will also learn about the safety of prolonged prone position compared to intermittent prone position. The main questions it aims to answer are:\n\n* Does prolonged prone position increase survival compared to intermittent prone position in participants with moderate to severe ARDS ?\n* How does prolonged prone position compare to intermittent prone position in terms of medical problems associated to prone position ?\n\nResearchers will compare prolonged versus intermittent prone position to see which approach is better to treat moderate to severe ARDS.\n\nParticipants will:\n\n* Receive prone position either in prolonged (\\> 48 hours) or daily (16 to 24 hours) sessions during the first 7 days\n* Be followed for up to 90 days to assess their clinical evolution",[26],[449,450,451,452],"ACUTE RESPIRATORY DISTRESS SYNDROME","RESPIRATORY FAILURE","PRONE POSITION","MECHANICAL VENTILATION","2026-05-14",{"date":455,"type":39},"2026-05-18",{"date":457,"type":39},"2025-04-07",{"date":459,"type":22},"2028-01",{"name":461,"class":46},"Pontificia Universidad Catolica de Chile",38,{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":78},"100402732","prediction-of-inspiratory-effort-response-to-high-peep-in-patients-recovering-from-ards-100402732","NCT04524091","Prediction of Inspiratory Effort Response to High PEEP in Patients Recovering From ARDS","Inclusion Criteria:\n\n* Need of invasive mechanical ventilation\n* Patients who had fulfill ARDS criteria based on Berlin definition during any time of invasive mechanical ventilation.\n* Patient ventilated in pressure support ventilation.\n* Time of invasive ventilation expected to be longer than 24 hs after the day of enrollment.\n\nExclusion Criteria:\n\n* Neuromuscular diseases (e.g., amyotrophic lateral sclerosis, Duchenne Erb)\n* previous diagnosis of chronic obstructed pulmonary disease\n* not resolved pneumothorax\n* bronchopleural fistula\n* suspicion of central respiratory drive alteration (e.g., benzodiazepines intoxication).",{"count":470,"type":22},30,"Spontaneous breathing during the transition from controlled to assisted ventilation in ARDS may be harmful, as high respiratory drive can generate large transpulmonary pressure swings and worsen lung injury. Higher PEEP may mitigate this by reducing inspiratory effort and lung stress, but patient response is variable and difficult to predict. While improved lung compliance appears to mediate the protective effects of PEEP, its bedside assessment is complex. Preclinical data suggest that changes in compliance are inversely reflected by changes in respiratory rate, but this relationship and its clinical utility in ARDS patients remain unclear.",[26],"2026-04-13",{"date":475,"type":39},"2026-04-16",{"date":477,"type":39},"2020-08-01",{"date":479,"type":22},"2026-08-01",{"name":481,"class":46},"Sanatorio Anchorena San Martin",{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":57,"phases":492,"briefSummary":493,"conditions":494,"keywords":496,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":506},"100578672","phase-3-continuous-positive-airway-pressure-on-venovenous-extracorporeal-membrane-oxygenation-for-acute-respiratory-distress-syndrome-100578672","NCT06814340","\"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme\"","\"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme\" - CALMDOWN","CALMDOWN","Inclusion Criteria:\n\n1. Severe acute respiratory distress syndrome refractory to conventional therapy placed on VV-ECMO support in the 48 hours (maximum tolerance : +2h) preceding inclusion.\n2. Obtain informed consent from a close relative or surrogate. According to the specifications of emergency inclusion, randomization without the close relative\u002Fsurrogate consent could be performed if the patient is unable to give his\u002Fher consent and when the close relative\u002Fsurrogate\u002Ffamily member are absent. Close relative\u002Fsurrogate\u002Ffamily member consent will be asked as soon as possible after randomization. The patient will be asked as soon as possible to give his\u002Fher consent for the continuation of the trial when his\u002Fher condition will allow.\n3. French Social security registration (except AME)\n\nExclusion Criteria:\n\n1. Age \\\u003C 18\n2. Pregnancy or breastfeeding\n3. Initiation of VV-ECMO \\> 48 h (maximum tolerance : +2h)\n4. Cardiac arrest with cumulated no flow time \\>10 minutes before ECMO (within 48 hours prior to inclusion)\n5. Irreversible neurological pathology\n6. End-stage chronic lung disease\n7. Contraindications for high PEEP level: untreated pneumothorax, barotrauma\n8. Irreversible ARDS with no hope for lung function recovery\n9. Patient moribund on the day of randomization, SAPS II \\>90\n10. Liver cirrhosis (Child B or C)\n11. Lung transplantation\n12. Burns on more than 20 % of the body surface\n13. Participation in another interventional study with a similar primary endpoint (mortality, lung transplantation, or duration of ECMO) or being in the exclusion period at the end of a previous study\n14. Individuals under guardianship, or permanently legally incompetent adults",{"count":491,"type":22},280,[318],"The CALMDOWN trial is a prospective, open-label, multicenter, comparative, controlled trial randomizing patients who received near apneic ventilation vs usual care on ECMO (ultra-protective lung ventilation).\n\nThe study goal is to investigate the benefit of early apneic ventilation in the most severe forms of acute respiratory distress syndrome (ARDS) rescued by ECMO.\n\nIndeed, our hypothesis is that that early (near) apneic ventilation on venovenous ECMO for severe ARDS can enhance ventilator injury prevention and therefore reduce ECMO duration and mortality at Day 60.",[26,495],"Extracorporeal Membrane Oxygenation Complication",[247,93,497],"CPAP","2026-04-08",{"date":473,"type":39},{"date":501,"type":39},"2025-05-06",{"date":503,"type":22},"2030-05-06",{"name":505,"class":46},"Assistance Publique - Hôpitaux de Paris",11,{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":514,"targetDuration":4,"studyType":57,"phases":516,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":4},"100629774","phase-3-to-evaluate-the-safety-and-potential-therapeutic-activity-of-jadicell-an-investigational-umbilical-cord-derived-mesenchymal-stem-cell-therapy-in-patients-diagnosed-with-acute-respiratory-distress-syndrome-ards-100629774","NCT07479043","To Evaluate the Safety and Potential Therapeutic Activity of JadiCell™, an Investigational Umbilical Cord-Derived Mesenchymal Stem Cell Therapy, in Patients Diagnosed With Acute Respiratory Distress Syndrome (ARDS).","Phase III Clinical Study of JadiCell™ (Umbilical Cord-Derived Mesenchymal Stem Cells) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)","Inclusion Criteria:\n\n1. Patients currently hospitalized\n2. Laboratory confirmation of ARDS\n3. Aged between 18 and 80 years\n4. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent\n5. SpO2 \\\u003C94% on room air requiring supplemental oxygen above baseline\n6. PaO2\u002FFiO2 \\\u003C300 mmHg\n7. Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan\n8. Requiring one of the following ï High Flow Oxygen Therapy ï Non-invasive Positive Pressure Ventilation (NIPPV, e.g. BiPAP and CPAP) ï Invasive Mechanical Ventilation (INV = intubated)\n\nExclusion Criteria:\n\n1. Greater than 96 h since hospitalization at the time of enrollment\n2. Greater than 48 h since intubation at the time of enrollment\n3. A previous MSC infusion not related to this trial\n4. History of Pulmonary Hypertension (WHO Class III\u002FIV)\n5. History of left atrial hypertension or decompensated left heart failure.\n6. Pregnant or lactating patient\n7. Unstable arrhythmia\n8. Patients currently receiving immunosuppression with exception of up to 10 mg Prednisone equivalents daily\n9. Patients currently receiving chronic dialysis\n10. Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO)\n11. Presence of any active malignancy (except non-melanoma skin cancer)\n12. Moderate to severe liver disease (AST and ALT \\>5 X ULN)\n13. Severe chronic respiratory disease with a PaCO2 \\> 50 mm Hg or the use of home oxygen at rest\n14. Septic Shock (with \\>1 vasopressor)\n15. Multi-organ failure\n16. Not expected to survive \\> 48 hours",{"count":515,"type":22},128,[318],"This study evaluates the safety and potential therapeutic activity of JadiCell™, an investigational umbilical cord-derived mesenchymal stem cell therapy, in patients diagnosed with Acute Respiratory Distress Syndrome (ARDS). JadiCells are administered intravenously and are intended to modulate inflammatory responses and promote tissue repair in injured lung tissue.",[26],[26,93,520,521,522,523],"Mesenchymal Stem Cells","Cell Therapy","Regenerative Medicine","Inflammation","2026-03-17",{"date":526,"type":39},"2026-03-19",{"date":528,"type":22},"2026-07",{"date":530,"type":22},"2026-12",{"name":532,"class":108},"Breathe Biologics, Inc.",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":539,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":541,"targetDuration":542,"studyType":23,"phases":4,"briefSummary":543,"conditions":544,"keywords":546,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":555,"locationsCount":78},"100627608","incidence-and-evolution-of-heart-lung-interaction-in-acute-respiratory-distress-syndrome-100627608","NCT07450846","Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome","Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome: the IVOLIA Study","IVOLIA","Inclusion Criteria:\n\n* Age ≥18 years old\n* Hospitalization in intensive care undergoing mechanical ventilation\n* Presence of ARDS according to the current consensus definition (Berlin definition)\n* Performance of at least one echocardiography during the first 24 hours of treatment, between the 2nd and 3rd day, between the 5th and 7th day, and within 48 hours of extubation\n\nExclusion Criteria:\n\nPregnancy Poor echogenicity preventing reliable measurement of the dimensions of the right and left ventricles.",{"count":240,"type":22},"2 Months","Acute respiratory distress syndrome (ARDS) is an inflammatory injury of the lungs caused by various serious illnesses, such as a bacterial or viral lung infection. It is treated by artificial ventilation with the application of positive pressure. Pulmonary injury, coupled with artificial ventilation, can lead to right heart failure which hinders the ejection of blood to the pulmonary circulation. Modern mechanical ventilation modalities have reduced the frequency (\"incidence\") of this right heart failure in acute respiratory distress syndrome. A large-scale study has shown this a few years ago. However, the evolution of right heart failure during artificial ventilation, and the consequences it has on the patient's cardiovascular status are poorly determined. This study is conducted to improve knowledge in this area. In adult patients hospitalized in intensive care presenting acute respiratory distress syndrome, the investigators will collect the data recorded on cardiac ultrasound, doses of cardiovascular drugs as well as variables reflecting hemodynamic status and cell oxygenation. Data will be collected during the course of ARDS and mechanical ventilation, as well as after weaning from artificial ventilation.",[26,545],"Right Heart Failure",[93,547,327,548],"heart-lung interactions","shock","2026-02-26",{"date":551,"type":39},"2026-03-05",{"date":553,"type":39},"2022-12-22",{"date":459,"type":22},{"name":556,"class":46},"Bicetre Hospital",{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":57,"phases":566,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":583},"100448768","phase-2-phase-2a-multiple-ascending-dose-study-in-hospitalized-patients-with-pneumonia-100448768","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",{"count":565,"type":22},120,[89],"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).",[26,569,570,571,572,573],"Viral or Bacterial Infections","Pneumonia","Pneumonia, Viral","Respiratory Infection","COVID-19 Acute Respiratory Distress Syndrome","2026-02-24",{"date":576,"type":39},"2026-02-27",{"date":578,"type":39},"2021-12-20",{"date":580,"type":22},"2026-06",{"name":582,"class":108},"Vasomune Therapeutics, Inc.",5,{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":591,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":57,"phases":594,"briefSummary":595,"conditions":596,"keywords":597,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":604,"locationsCount":78},"100626762","phase-1-mesenchymal-stem-cells-mscs-and-conditioned-medium-mesenchymal-stem-cells-as-adjuvant-therapy-for-sepsis-100626762","NCT07439848","Mesenchymal Stem Cells (MSCs) and Conditioned Medium Mesenchymal Stem Cells as Adjuvant Therapy for Sepsis","A Randomized, Double-Blind, Controlled Trial Evaluating the Potential of Mesenchymal Stem Cells and Their Secretome as Adjuvant Therapy to Reduce Length of Hospital Stay and Mortality in Patients With Sepsis Due to Pneumonia","Inclusion Criteria:\n\n* Male or female at least 40 years old when the Informed Consent Form (ICF) is signed by the family, as evidenced by an identity card.\n* Patients with severe ARDS according to Berlin criteria\n* Families are willing to participate in clinical trial procedures including not participating in other clinical trials for the duration of participation.\n\nExclusion Criteria:\n\n* A pregnant woman is proven by a pregnancy test.\n* The results of the SGOT or SGPT examination increased \\> 5 times the upper limit of the normal laboratory value in the hospital.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 ml\u002Fmin, including patients undergoing routine hemodialysis.\n* Having more than 2 of the following co-morbidities; hypertension, diabetes, chronic heart disease, chronic lung disease, COPD, asthma, tuberculosis, cancer, chronic kidney disease, immunosuppressive disease, HIV.\n* The results of the lipid profile are far above normal (what is the cut off number?). Normal cholesterol levels for women aged 20 years and over are 125-200 mg\u002FdL with LDL below 100 mg\u002FdL and HDL above 40 mg\u002FdL. It is said to have high cholesterol when the level in the blood reaches more than 239 mg\u002FdL. Normal cholesterol levels for men aged 20 years or older are 125-200 mg\u002FdL with LDL below 100 mg\u002FdL and HDL above 40 mg\u002FdL. It is said to have high cholesterol when the level in the blood reaches more than 239 mg\u002FdL.\n* PT APTT, C Peptide","40 Years",{"count":593,"type":22},15,[375,89],"This study was conducted to determine the effect of Umbilical Cord Mesenchymal Stem Cell (UC-MSC) and Secretome in severe ARDS patients. The study is a randomized control trial - double blind, which has 3 arms intervention namely, Control treatment, UC-MSC treatment, and UC-MSC and Secretome treatment.",[26],[26,520,598],"Secretome","2026-02-23",{"date":576,"type":39},{"date":602,"type":39},"2023-12-25",{"date":530,"type":22},{"name":605,"class":108},"PT. Prodia Stem Cell Indonesia",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":613,"enrollmentInfo":614,"targetDuration":4,"studyType":57,"phases":616,"briefSummary":617,"conditions":618,"keywords":619,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":628,"locationsCount":630},"100466469","phase-3-extracellular-vesicle-treatment-for-acute-respiratory-distress-syndrome-ards-extinguish-ards-100466469","NCT05354141","Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)","Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles for Hospitalized Patients With Moderate-to-Severe ARDS: A Phase III Clinical Trial","Inclusion Criteria:\n\n1. Men and women aged 18-75 years of age\n2. Presence of the following criteria for moderate to severe ARDS as defined by the Berlin Criteria within 24 hours of the first infustion:\n\n   1. Onset within 7 days of known clinical insult or requiring increasing respiratory rate, increasing oxygen flows, or increased work of breathing, and\n   2. Bilateral lung opacities not fully explained by pleural effusions, atelectasis, or nodules, and\n   3. PaO2\u002FFiO2 (P\u002FF ratio) ≤ 200 mm Hg, and\n   4. Invasive or noninvasive ventilation with a minimum PEEP 5 cm H2O or minimum of continuous positive airway pressure (CPAP) 5 cm H2O, or High Flow Nasal Oxygen at ≥ 30 L\u002Fmin, and\n   5. Respiratory failure not fully explained by cardiac failure or fluid overload.\n\nExclusion Criteria:\n\n1. Lack of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).\n2. Stated unwillingness to comply with all study procedures and availability for the duration of the study\n3. Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent.\n4. Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers.\n5. Major physical trauma in the last 2 days, including motor vehicle accidents, assaults, mechanical falls with sequelae of significant bleeding or craniofacial bruising, and surgeries, such that not one or more injury may be undiagnosed at time of screening.\n6. Duration of mechanical ventilation exceeds 3 days or 72 hours from diagnosis of ARDS.\n7. ALT or AST \\> 8 x Upper Limit of Normal (ULN).\n8. Documented history of cirrhosis.\n9. DNR order, as in electing not to receive chest compressions, cardiac defibrillation, cardiac drugs, or intubation.\n10. Moribund-expected survival \\\u003C 24 hours.\n11. Severe metabolic disturbances at randomization (e.g., ketoacidosis, pH \\\u003C 7.2)\n12. Patient currently connected to Extracorporeal Membrane Oxygenation at initiation of screening.\n13. If the candidate, either a male or female of reproductive potential, is unwilling to two methods of highly effective birth control contraception such as condoms with oral contraceptive pill or choose to remain abstinent if already practicing abstinence during the screening period. The required duration of usage of double method OR maintenance of abstinence must include the time from the beginning of the screening period until Day 61, day of withdrawal or early termination\n14. Use of investigational COVID-19 agents or any other investigational agents within 30 days prior to the first dose.","75 Years",{"count":615,"type":22},970,[318],"To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for the treatment of hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).",[26,93],[620,621,622,93],"ExoFlo","Extracellular Vesicles","Exosome","2026-02-20",{"date":599,"type":39},{"date":626,"type":39},"2022-07-01",{"date":229,"type":22},{"name":629,"class":108},"Direct Biologics, LLC",32]