[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PPD Development, LP\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,63,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100570010","phase-2-just-breathe-breathing-life-into-innovative-therapies-for-ards--cohort-a-vilobelimab-100570010",false,"NCT06701682","JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab","Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)","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\n* No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol NCT06703073.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"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.\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.",[26,27,28,29],"Acute Respiratory Distress Syndrome (ARDS)","ARDS","ARDS (Acute Respiratory Distress Syndrome)","Acute Respiratory Distress Syndrome",[31,32,27,29,33],"BARDA","JUST BREATHE","Acute Respiratory Failure","RECRUITING","2026-05-07",{"date":37,"type":38},"2026-05-08","ACTUAL",{"date":40,"type":38},"2025-06-21",{"date":42,"type":20},"2028-09",{"name":44,"class":45},"PPD Development, LP","INDUSTRY",40,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":14,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":62,"locationsCount":46},"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",{"count":19,"type":20},[23],"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.",[26,27,28,29],[31,32,27,29,33],{"date":37,"type":38},{"date":60,"type":38},"2025-06-10",{"date":42,"type":20},{"name":44,"class":45},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":14,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":72,"conditions":73,"keywords":74,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":78,"locationsCount":46},"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)","Inclusion Criteria:\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\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 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.\n\nNOTE: Patients on chronic low dose immunosuppressive therapy may be enrolled at the discretion of the investigator in consultation with the medical monitor.\n\n* Participant is undergoing active cancer systemic chemotherapy.\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":70,"type":20},600,[23],"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.",[26,27,28,29],[31,32,27,29,33],{"date":37,"type":38},{"date":60,"type":38},{"date":42,"type":20},{"name":44,"class":45},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":14,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":94,"locationsCount":46},"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 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.",{"count":19,"type":20},[23],"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.",[26,27,28,29],[31,32,27,29,33],{"date":37,"type":38},{"date":92,"type":38},"2025-10-28",{"date":42,"type":20},{"name":44,"class":45},""]