[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652806":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":31,"centralContacts":35,"locations":12,"responsibleParty":45,"collaborators":47,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":12,"enrollmentInfo":73,"targetDuration":12,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":86,"whyStopped":12,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":12},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual Care","NO_INTERVENTION","Usual care of ICU patients with ARDS. Patients randomized to the control arm or usual care will not receive simvastatin or baricitinib for 28 days or discharge from the ICU.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Simvastatin","ACTIVE_COMPARATOR","Simvastatin will be administered at a dose of 80 mg once daily by the enteral route for up to 28 days",[18],"Drug: Simvastatin",{"label":20,"type":15,"description":21,"interventionNames":22},"Baricitinib","Baricitinib will be administered at a dose of 4 mg once daily by the enteral route for up to 10 days.Baricitinib will be prescribed on the participants' in-patient drug administration chart (or equivalent) and administered to the participant by appropriately trained clinical staff with appropriate competencies in accordance with local practice. These staff do not need to be on the study delegation log.\n\nThe dosing regimen below will be used in the setting of renal impairment:\n\neGFR 30 to \\\u003C60 mL\u002Fmin Baricitinib Dose: 2mg\n\neGFR15 to \\\u003C30 mL\u002Fmin Baricitinib Dose:1mg\n\neGFR \\\u003C15 mL\u002Fmin (or receiving RRT) Baricitinib Dose withheld",[23],"Drug: Baricitinib",[25,28],{"type":26,"name":14,"description":16,"armGroupLabels":27,"otherNames":12},"DRUG",[14],{"type":26,"name":20,"description":29,"armGroupLabels":30,"otherNames":12},"Baricitinib will be administered at a dose of 4 mg once daily by the enteral route for up to 10 days.Baricitinib will be prescribed on the participants' in-patient drug administration chart (or equivalent) and administered to the participant by appropriately trained clinical staff with appropriate competencies in accordance with local practice. These staff do not need to be on the study delegation log. The dosing regimen below will be used in the setting of renal impairment: eGFR 30 to \\\u003C60 mL\u002Fmin Baricitinib Dose: 2mg eGFR15 to \\\u003C30 mL\u002Fmin Baricitinib Dose:1mg eGFR \\\u003C15 mL\u002Fmin (or receiving RRT) Baricitinib Dose withheld",[20],[32],{"name":33,"affiliation":5,"role":34},"Neil Aggarwal, MD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":12,"email":40},"Carrie B Higgins, BSN","CONTACT","3037240961","carrie.higgins@cuanschutz.edu",{"name":42,"role":38,"phone":43,"phoneExt":12,"email":44},"Jeffrey McKeehan, MSN AC-AGNP","3037246080","jeffrey.mckeehan@cuanschutz.edu",{"type":46,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[48,50,52,54,56,58,60,62],{"name":49,"class":6},"Vanderbilt University School of Medicine",{"name":51,"class":6},"Emory University",{"name":53,"class":6},"Wake Forest University",{"name":55,"class":6},"New York University",{"name":57,"class":6},"University of California, San Francisco",{"name":59,"class":6},"Montefiore Medical Center",{"name":61,"class":6},"University of Pennsylvania",{"name":63,"class":6},"Intermountain Health Care, Inc.","100652806","phase-2-precision-medicine-adaptive-network-platform-trial-in-hypoxemic-acute-respiratory-failure-100652806",false,"NCT07779642","Precision Medicine Adaptive Network Platform Trial in Hypoxemic Acute Respiratory Failure","US-PANTHER","Inclusion Criteria:\n\nCritically ill patients in hospital and at least 1 of the following:\n\n1. Acute respiratory distress syndrome (ARDS). ARDS as defined by:\n\n   1. a known acute clinical insult or new or worsening respiratory dysfunction\n   2. receiving respiratory support via invasive mechanical ventilation or non- invasive mechanical ventilation including continuous positive airway pressure, or high flow nasal oxygen greater than or equal to 30L\u002Fmin\n   3. within the same 24-hour time period:\n\n   i. bilateral opacities on chest imaging not fully explained by effusion, lobar\u002Flung collapse\u002Fatelectasis, or nodules ii. respiratory failure not fully explained by cardiac failure, fluid overload, pulmonary embolism, acute airway disease iii. Pa02\u002FFi02 ration \\\u003C40 kPa from arterial blood gases, or Sp02 \\\u003C315 from pulse oximetry where Sp02 \\\u003C97\n2. A pandemic associated syndrome\n\nExclusion criteria:\n\nSimvastatin:\n\n1. More than 48 hours from the diagnosis of AHRF\n2. Patient is known to be pregnant\n3. Liver transaminases \\>8 times the upper limit of the normal range\n4. Creatine kinase \\>10 times the upper limit of the normal range\n5. Currently receiving ongoing treatment with any of the following: itraconazole, ketoconazole, HIV protease inhibitors, nefazodone, cyclosporine, amiodarone, verapamil, or diltiazem.\n6. Severe renal impairment (eGFR \\\u003C 30mL\u002Fmin and not receiving renal replacement therapy).\n7. Current or recent treatment (within 2 weeks) with statins\n8. Physician decision that a statin is required for proven indication\n9. Contraindication to enteral drug administration, e.g., patients with mechanical bowel obstruction. Patients with high gastric aspirates due to an ileus are not excluded.\n10. Known hypersensitivity to simvastatin\n\nBaricitinib\n\n1. More than 48 hours from the diagnosis of AHRF\n2. Patient is known to be pregnant\n3. Liver transaminases \\>8 times the upper limit of the normal range\n4. Absolute neutrophil count less than 0.5x10 9\u002FL\n5. Currently receiving ongoing immunosuppressants (high dose corticosteroids, B and T cell targeted therapies, interferon, or JAK inhibitors)\n6. Severe renal impairment (eGFR \\\u003C 15mL\u002Fmin) or receiving renal replacement therapy\n7. Known active tuberculosis infection or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines.\n8. Contraindication to enteral drug administration, e.g., patients with mechanical bowel obstruction. Patients with high gastric aspirates due to an ileus are not excluded.\n9. Known hypersensitivity to baricitinib","ALL","18 Years",{"count":74,"type":75},300,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","The goal of this trial is to accelerate the development of pharmacological therapies for critical illness by identifying biological subphenotypes in patients with acute respiratory distress syndrome (ARDS). The trial will stratify participants by biological markers into different subphenotypes, then randomized 1:1:1 to active treatment 1, active treatment 2, or usual care. Initial stratification will be into hyperinflammatory and hypoinflammatory subphenotypes in ARDS based on plasma biomarker profiles. Regular adaptive analyses will enable efficient identification of treatment effects within each subphenotype, stopping interventions where there is evidence of efficacy or futility, and bringing in new interventions and potentially new subphenotypes.",[81,82],"ARDS (Acute Respiratory Distress Syndrome)","Acute Hypoxic Respiratory Failure",[84,85],"ARDS","acute hypoxic respiratory failure","NOT_YET_RECRUITING","2026-08-18",{"date":89,"type":90},"2026-08-21","ACTUAL",{"date":92,"type":75},"2026-09",{"date":94,"type":75},"2030-09",{"name":5,"class":6}]