Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT06658535
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2024-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose Escalation Study of NanO2 in Patients With Mild Respiratory Distress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008806', 'term': 'perfluoropentane'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Up to six subjects will be enrolled at each dose level'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2024-09-26', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Respiratory Rate Oxygenation (ROX) Index score', 'timeFrame': '24 hours', 'description': 'Change in ROX Index from baseline. ROX Index = 100\\*(SaO2/FiO2)/respiratory rate'}, {'measure': 'World Health Organization (WHO) 8-point scale for clinical assessments', 'timeFrame': '28 days', 'description': 'Evaluate distribution of WHO 8-point ordinal scale at various time points throughout the study. Clinical assessment assigning clinical status of increasing severity from 1 to 8.'}, {'measure': 'NanO2 Oxygenation', 'timeFrame': '2 days', 'description': 'Duration of NanO2 oxygenation response as measured by pulse oximetry'}, {'measure': 'Determine the effects of NanO2 on PaO2 measurements', 'timeFrame': '2 days', 'description': 'Comparisons of PaO2 measurements before, during and after NanO2 infusions'}], 'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose', 'timeFrame': '28 Days', 'description': 'To determine the Maximum Tolerated Dose of NanO2 in subjects with Mild Respiratory Distress.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': '28 days', 'description': 'Cumulative incidence of adverse events and serious adverse events'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory distress'], 'conditions': ['Mild Respiratory Distress']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/min/1.73m2 (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/kg/min 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"}, 'identificationModule': {'nctId': 'NCT06658535', 'acronym': 'EXTEND-1b', 'briefTitle': 'A Dose Escalation Study of NanO2 in Patients With Mild Respiratory Distress', 'organization': {'class': 'INDUSTRY', 'fullName': 'NuvOx LLC'}, 'officialTitle': 'Novel Oxygen Therapeutic NanO2 for Mild Respiratory Distress in Phase 1b', 'orgStudyIdInfo': {'id': 'EXTEND 1b'}, 'secondaryIdInfos': [{'id': '75A50123C00034', 'type': 'OTHER_GRANT', 'domain': 'ASPR-BARDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 0.025', 'description': 'Loading dose = 0.025 mL/kg followed sustained IV infusion of 0.375 mL/kg over 21 hours.', 'interventionNames': ['Drug: dodecafluoropentane (0.025 mL/kg)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 0.032', 'description': 'Loading dose of 0.032 mL/kg followed sustained IV infusion of 0.48 mL/kg over 21 hours.', 'interventionNames': ['Drug: dodecafluoropentane (0.032 mL/kg)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 0.050', 'description': 'Loading dose of 0.050 mL/kg followed by sustained IV infusion of 0.75 mL/kg over 21 hours.', 'interventionNames': ['Drug: dodecafluoropentane (0.050 mL/kg)']}], 'interventions': [{'name': 'dodecafluoropentane (0.025 mL/kg)', 'type': 'DRUG', 'otherNames': ['NanO2™'], 'description': 'dodecafluoropentane (0.025 mL/kg)', 'armGroupLabels': ['Cohort 0.025']}, {'name': 'dodecafluoropentane (0.032 mL/kg)', 'type': 'DRUG', 'otherNames': ['NanO2™'], 'description': 'dodecafluoropentane (0.032 mL/kg)', 'armGroupLabels': ['Cohort 0.032']}, {'name': 'dodecafluoropentane (0.050 mL/kg)', 'type': 'DRUG', 'otherNames': ['NanO2™'], 'description': 'dodecafluoropentane (0.050 mL/kg)', 'armGroupLabels': ['Cohort 0.050']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6L 5X8', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Anushka Jayasekara', 'role': 'CONTACT', 'email': 'Anushka.Jayasekara@covenanthealth.ca', 'phone': '587-590-5295'}, {'name': 'Janek Senaratne, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Grey Nun Community Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Danaë Tassy, PhD', 'role': 'CONTACT', 'email': 'danae.tassy.cemtl@ssss.gouv.qc.ca', 'phone': '514-252-3400', 'phoneExt': '4679'}, {'name': 'François Marquis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Maisonneuve Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'NuvOx Pharma', 'role': 'CONTACT', 'email': 'EXTEND_Clinical@nuvoxpharma.com', 'phone': '520-624-6688'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NuvOx LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}