Testing NanO2 for patients with mild respiratory distress
Novel Oxygen Therapeutic NanO2 for Mild Respiratory Distress in Phase 1b
This study is testing a new treatment called NanO2 to see if it can help people with mild breathing problems who might need a ventilator.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NuvOx LLC Industry-sponsored |
| Locations | 2 sites (Edmonton, Alberta and 1 other locations) |
| Trial ID | NCT06658535 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and dosing of NanO2™ in patients experiencing mild respiratory distress who are at risk of requiring mechanical ventilation. It is a Phase 1 dose escalation study that aims to establish appropriate dosing guidelines for future research. Participants will receive varying doses of dodecafluoropentane to assess its effects on their condition.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients requiring supplemental oxygen but not exceeding 6L via nasal cannula to maintain adequate oxygen saturation.
Not a fit: Patients with severe respiratory conditions requiring advanced interventions like extracorporeal membrane oxygenation or those with unstable hemodynamics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with mild respiratory distress, potentially reducing the need for mechanical ventilation.
How similar studies have performed: While this approach is novel, similar studies exploring innovative treatments for respiratory distress have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edmonton, Alberta and 1 other locations
- Grey Nun Community Hospital — Edmonton, Alberta, Canada (Recruiting)
- Hôpital Maisonneuve Rosemont — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: NuvOx Pharma
- Email: EXTEND_Clinical@nuvoxpharma.com
- Phone: 520-624-6688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.