Recruiting NCT06658535
A Dose Escalation Study of NanO2 in Patients With Mild Respiratory Distress
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dodecafluoropentane (0.025 mL/kg), dodecafluoropentane (0.032 mL/kg), dodecafluoropentane (0.050 mL/kg).
- Who it may be relevant to
- Registry conditions: Mild Respiratory Distress. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Novel Oxygen Therapeutic NanO2 for Mild Respiratory Distress in Phase 1b
Overview
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.
Interventions
- Drug dodecafluoropentane (0.025 mL/kg)
dodecafluoropentane (0.025 mL/kg) - Drug dodecafluoropentane (0.032 mL/kg)
dodecafluoropentane (0.032 mL/kg) - Drug dodecafluoropentane (0.050 mL/kg)
dodecafluoropentane (0.050 mL/kg)
Primary outcome measures
- Maximum Tolerated Dose [Time frame: 28 Days]
Secondary outcome measures (1)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: 28 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- Grey Nun Community Hospital — Edmonton
- Hôpital Maisonneuve Rosemont — Montreal
Identifiers
NCT: NCT06658535 · EXTEND 1b · 75A50123C00034