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RecruitingPhase 1NCT06658535

A Dose Escalation Study of NanO2 in Patients With Mild Respiratory Distress

Novel Oxygen Therapeutic NanO2 for Mild Respiratory Distress in Phase 1b

Sponsor

NuvOx LLC

Enrollment

18 participants

Start Date

Mar 13, 2025

Study Type

INTERVENTIONAL

Conditions

Mild Respiratory Distress

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria10

  • 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

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Interventions

DRUGdodecafluoropentane (0.025 mL/kg)

dodecafluoropentane (0.025 mL/kg)

DRUGdodecafluoropentane (0.032 mL/kg)

dodecafluoropentane (0.032 mL/kg)

DRUGdodecafluoropentane (0.050 mL/kg)

dodecafluoropentane (0.050 mL/kg)

Locations(2)

Grey Nun Community Hospital

Edmonton, Alberta, Canada

Hôpital Maisonneuve Rosemont

Montreal, Quebec, Canada

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NCT06658535