NanO2 for Shortness of Breath

(EXTEND-1b Trial)

Recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called NanO2, an experimental therapy for individuals experiencing mild respiratory distress and at risk of needing a ventilator. The goal is to determine the optimal dose for future use. Participants will receive varying amounts of NanO2 to assess their reactions. Candidates may qualify if hospitalized for breathing problems and require extra oxygen through a nasal tube, but not exceeding 6 liters per minute. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that NanO2 is likely to be safe for humans?

In a previous study, patients who took NanO2 did not experience any serious safety issues. Early reports suggest it is well-tolerated. NanO2 is currently in Phase 1, the early testing phase. Researchers are still learning about its safety in humans, and it hasn't been fully proven yet.

Research has shown that NanO2 is based on sodium nitrite. High amounts of sodium nitrite can cause breathing problems, headaches, nausea, and other issues, depending on the dose and exposure level. This trial carefully checks safe dose levels to avoid such problems.

Since this treatment is in the early testing phase, its complete safety profile is not yet known. Researchers closely monitor participants to ensure their safety and to determine the right dose for future studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for shortness of breath, which often include inhalers, oxygen therapy, or medications like bronchodilators and steroids, NanO2 offers a unique approach. It utilizes a novel delivery method involving a specific intravenous (IV) infusion that is designed to enhance oxygen delivery directly to the bloodstream. This method could potentially provide more immediate and sustained relief from symptoms. Researchers are excited about NanO2 because it promises a new mechanism of action that directly targets oxygen transport, which could revolutionize how we manage breathing difficulties.

What evidence suggests that NanO2 might be an effective treatment for shortness of breath?

Research has shown that sodium nitrite, the key ingredient in NanO2, may help improve lung function. In a study with heart failure patients, a short-term infusion of sodium nitrite into the bloodstream produced positive results, suggesting it might also aid with breathing problems. Additionally, in asthma patients, it improved lung function, including the volume of air exhaled in one second. While these results are encouraging, further research is needed to confirm if it can reduce the need for machines during severe respiratory issues. Participants in this trial will receive different dosages of NanO2 to evaluate its effectiveness for shortness of breath. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. researchgate.net researchgate.net/publication/347951793_Efficacy_and_safety_of_inhaled_nebulized_sodium_nitrite_in_asthmatic_patients

(PDF) Efficacy and safety of inhaled nebulized sodium ... The primary outcome was the forced expiratory volume in 1 s (FEV1). The secondary outcomes were other lung function parameters, unplanned asthma ...

2. ahajournals.org ahajournals.org/doi/10.1161/circheartfailure.114.001716

Short-Term Intravenous Sodium Nitrite Infusion Improves ... This first-in-human HF efficacy/safety study demonstrates an attractive profile during short-term systemic NaNO2 infusion that may be beneficial ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK592476/

HEALTH EFFECTS - Toxicological Profile for Nitrate and Nitrite There was no evidence of exposure-related pulmonary effects (e.g., respiratory resistance, static lung performance, functional residual capacity) in ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1344622322001341

Four cases of sodium nitrite suicidal ingestion: A new trend ... We present four cases of suicidal sodium nitrite ingestion that closely occurred within a two months-period.

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/02/NCT03015402/Prot_SAP_000.pdf

Oral Nitrite in Patients with Pulmonary Hypertension and ... Spirometry infrequently can make the chest tight or lead to shortness of breath. Albuterol will be available if this occurs. Rarely, a subject may have ...

6. fishersci.com fishersci.com/content/dam/fishersci/en_US/documents/programs/education/regulatory-documents/sds/chemicals/chemicals-s/S25560.pdf

Safety Data Sheet Give artificial respiration if necessary. If breathing is difficult give oxygen.Loosen clothing and place exposed in a comfortable position.

7. nj.gov nj.gov/health/eoh/rtkweb/documents/fs/2258.pdf

Sodium nitrite Exposure to very high levels can cause trouble breathing, collapse and even death. ► Sodium Nitrite can cause headache, nausea, vomiting, diarrhea and ...

8. sigmaaldrich.com sigmaaldrich.com/DE/en/sds/aldrich/563218?srsltid=AfmBOorRPx-YQThzVvPmFc5H20uDIiemA6ASPfKZrXUpiXhgFIDYBb0n

• SAFETY DATA SHEET Special protective equipment for fire- fighters. : Stay in danger area only with self-contained breathing apparatus. Prevent skin contact by keeping a safe.

9. chemtradelogistics.com chemtradelogistics.com/wp-content/uploads/2020/08/SDS-Sodium_Nitrite_Solution_40_CHE-2021S.pdf

Sodium Nitrite Solution 40% Signal Word. : Danger. Hazard Statements. : H301 - Toxic if swallowed. H319 - Causes serious eye irritation. H400 - Very toxic to aquatic life.

10. physics.purdue.edu physics.purdue.edu/primelab/safety/MSDS/SDS/sodium%20nitrite%20%20%20-%20Spectrum.pdf

SODIUM NITRITE, GRANULAR, USP Dyspnea (Shortness of breath and difficulty breathing). May cause chemical pneumonitis. May cause pulmonary edema. May cause methemoglobinemia and cyanosis ...