A Dose Escalation Study of NanO2 in Patients with Mild Respiratory Distress
Phase 1
Not yet recruiting
- Conditions
- Mild Respiratory Distress
- Interventions
- Registration Number
- NCT06658535
- Lead Sponsor
- NuvOx LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Requiring supplemental oxygen but ≤ 6L oxygen by nasal cannula to maintain an oxygen saturation >92% or PaO2 >60mmHg
- Admitted to a hospital with symptoms of mild RD
- Signed informed consent obtained from the subject or subject's legally authorized representative
- Agrees to not participate in another clinical trial for the treatment of mild RD through Day 28
Exclusion Criteria
- Presence of extracorporeal membrane oxygenation
- Unstable hypertension
- 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)
- Presence of pulmonary embolism at baseline
- Evidence of right ventricular heart failure
- Unstable hemodynamically as defined by receiving 0.5μg/kg/min or greater norepinephrine
- Inability to comply with the study procedures
- Currently pregnant or breastfeeding
- Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 48 hours
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 0.025 dodecafluoropentane (0.025 mL/kg) Loading dose = 0.025 mL/kg followed sustained IV infusion of 0.375 mL/kg over 21 hours. Cohort 0.050 dodecafluoropentane (0.050 mL/kg) Loading dose of 0.050 mL/kg followed by sustained IV infusion of 0.75 mL/kg over 21 hours. Cohort 0.032 dodecafluoropentane (0.032 mL/kg) Loading dose of 0.032 mL/kg followed sustained IV infusion of 0.48 mL/kg over 21 hours.
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose 28 Days To determine the Maximum Tolerated Dose of NanO2 in subjects with Mild Respiratory Distress.
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 28 days Cumulative incidence of adverse events and serious adverse events