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NCT Number: NCT06658535

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

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Grey Nun Community Hospital, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dodecafluoropentane (0.025 mL/kg)

Drug

dodecafluoropentane (0.025 mL/kg)

Other names: NanO2™

dodecafluoropentane (0.032 mL/kg)

Drug

dodecafluoropentane (0.032 mL/kg)

Other names: NanO2™

dodecafluoropentane (0.050 mL/kg)

Drug

dodecafluoropentane (0.050 mL/kg)

Other names: NanO2™

Primary outcomes

  1. Maximum Tolerated Dose

    Time frame: 28 Days

    To determine the Maximum Tolerated Dose of NanO2 in subjects with Mild Respiratory Distress.

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 28 days

    Cumulative incidence of adverse events and serious adverse events

Other outcomes

  1. Change in Respiratory Rate Oxygenation (ROX) Index score

    Time frame: 24 hours

    Change in ROX Index from baseline. ROX Index = 100*(SaO2/FiO2)/respiratory rate

  2. World Health Organization (WHO) 8-point scale for clinical assessments

    Time frame: 28 days

    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.

  3. NanO2 Oxygenation

    Time frame: 2 days

    Duration of NanO2 oxygenation response as measured by pulse oximetry

  4. Determine the effects of NanO2 on PaO2 measurements

    Time frame: 2 days

    Comparisons of PaO2 measurements before, during and after NanO2 infusions

Study contacts

Contact information is provided by the study sponsor or research team.

NuvOx Pharma

CONTACT

[email protected]

520-624-6688

Sponsors and collaborators

Lead sponsor

NuvOx LLC

Industry

Registry information

Official study title

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

Acronym: EXTEND-1b

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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