[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NuvOx LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,31],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":4,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":16,"phases":4,"briefSummary":17,"conditions":18,"keywords":4,"overallStatus":23,"whyStopped":4,"lastUpdateSubmitDate":24,"lastUpdatePostDateStruct":25,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":28,"locationsCount":4},"100650443","nuvox-expanded-access-100650443",false,"NCT07748299","NuvOx Expanded Access","* Inclusion Criteria:\n\n  1. Patients must have a condition that is serious or immediately life-threatening.\n  2. Patients must have exhausted other treatment options or are ineligible to participate in ongoing clinical trials.\n  3. The potential benefits of treatment with NanO₂ must outweigh the potential risks, as determined at the discretion of the treating physician and NuvOx.\n* Exclusion criteria:\n\n  1. Providing NanO₂ for the requested use will interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the use.\n\n     * A request will be evaluated against the criteria of 21 CFR 312.305(a) and 312.310(a).\n\n       * NuvOx will consider the totality of available information, including applicable nonclinical and clinical experience, the patient's condition, and the treating physician's rationale for use.","ALL","EXPANDED_ACCESS","NanO₂ is an investigational drug being studied by NuvOx Therapeutics. It has not been approved by the U.S. Food and Drug Administration (FDA) for any use. This record describes a way for a patient's own doctor to request NanO₂ for that patient outside of a clinical trial, through a pathway called \"expanded access\" (sometimes called \"compassionate use\").\n\nThis option may be considered for patients who have a serious or life-threatening illness, who have already tried other available treatments, and who cannot join an ongoing NanO₂ clinical trial. NuvOx's RESTORE study in glioblastoma has finished enrolling patients, and NuvOx does not currently have any other NanO₂ study open for enrollment in the United States.\n\nUnder this pathway, the patient's treating physician - not NuvOx - applies to the FDA and manages the patient's care. NuvOx's role is to review each request, and if approved, provide the drug and the regulatory information the FDA needs to evaluate it. Each request is reviewed individually, and approval is not guaranteed.",[19,20,21,22],"Glioblastoma","Respiratory Distress Syndrom","Ischemic Stroke","Hypoxic Conditions","AVAILABLE","2026-08-03",{"date":26,"type":27},"2026-08-05","ACTUAL",{"name":29,"class":30},"NuvOx LLC","INDUSTRY",{"id":32,"slug":33,"hasResults":11,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":11,"sex":15,"minAge":39,"maxAge":4,"enrollmentInfo":40,"targetDuration":4,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":5},"100566696","phase-1-a-dose-escalation-study-of-nano2-in-patients-with-mild-respiratory-distress-100566696","NCT06658535","A Dose Escalation Study of NanO2 in Patients With Mild Respiratory Distress","Novel Oxygen Therapeutic NanO2 for Mild Respiratory Distress in Phase 1b","EXTEND-1b","Inclusion Criteria:\n\n* Requiring supplemental oxygen but ≤ 6L oxygen by nasal cannula to maintain an oxygen saturation \\>92% or PaO2 \\>60mmHg\n* Admitted to a hospital with symptoms of mild RD\n* Signed informed consent obtained from the subject or subject's legally authorized representative\n* Agrees to not participate in another clinical trial for the treatment of mild RD through Day 28\n\nExclusion Criteria:\n\n* Presence of extracorporeal membrane oxygenation\n* Unstable hypertension\n* History of significantly impaired renal function defined as an eGFR ≤ 30mL\u002Fmin\u002F1.73m2 (MDRD equation or similar) or impaired hepatic function defined as the presence of decompensated cirrhosis (acute deterioration in liver function characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage)\n* Presence of pulmonary embolism at baseline\n* Evidence of right ventricular heart failure\n* Unstable hemodynamically as defined by receiving 0.5μg\u002Fkg\u002Fmin or greater norepinephrine\n* Inability to comply with the study procedures\n* Currently pregnant or breastfeeding\n* Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 48 hours\n* History or evidence of any other clinically significant condition that, in the opinion of the investigator, might pose a safety risk to subjects or interfere with study procedures, evaluation, or completion","18 Years",{"count":41,"type":42},18,"ESTIMATED","INTERVENTIONAL",[45],"PHASE1","EXTEND is a dose escalation study of NanO2™ in patients with mild respiratory distress who are at risk for mechanical ventilation. The study will establish dosing guidelines for a Phase 2 study.",[48],"Mild Respiratory Distress",[50],"respiratory distress","RECRUITING","2026-01-27",{"date":54,"type":27},"2026-01-28",{"date":56,"type":27},"2025-03-13",{"date":58,"type":42},"2026-12",{"name":29,"class":30},""]