NanO2 for Shortness of Breath

(EXTEND-1b Trial)

Recruiting at 1 trial location

Overseen By NuvOx Pharma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NuvOx LLC

Disqualifiers: Unstable hypertension, Renal impairment, Hepatic impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 days

18 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for hospitalized patients with mild respiratory distress who need a little extra oxygen (up to 6L by nasal cannula) to keep their oxygen levels above 92% or PaO2 over 60mmHg. Participants must consent and agree not to join another RD treatment study until Day 28.

Inclusion Criteria

I have signed the consent form or my legal representative has.

I was hospitalized with mild respiratory distress.

I need extra oxygen but no more than 6L/min to keep my oxygen levels above 92%.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a loading dose followed by a sustained IV infusion of NanO2 over 21 hours

2 days

1 visit (in-patient)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and clinical assessments

28 days

Treatment Details

Interventions

• NanO2

Trial Overview The EXTEND study tests different doses of NanO2™, a drug intended to help with breathing issues without needing mechanical ventilation. It's a step towards finding the right dose for future studies.

Participant Groups

Group I: Cohort 0.050 Experimental Treatment 1 Intervention

Loading dose of 0.050 mL/kg followed by sustained IV infusion of 0.75 mL/kg over 21 hours.

Group II: Cohort 0.032 Experimental Treatment 1 Intervention

Loading dose of 0.032 mL/kg followed sustained IV infusion of 0.48 mL/kg over 21 hours.

Group III: Cohort 0.025 Experimental Treatment 1 Intervention

Loading dose = 0.025 mL/kg followed sustained IV infusion of 0.375 mL/kg over 21 hours.

Who Is Running the Clinical Trial?

NuvOx LLC

Lead Sponsor

Trials

7

Recruited

610+