← Back to Search

Other

S-Nitrosylation Therapy for COVID-19

Phase < 1

Waitlist Available

Led By Robert Schilz, DO, PhD

Research Sponsored by Robert Schilz

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients enrolled and able to start ENO treatment after oxygen stabilization

Spontaneously breathing subjects receiving > 4 liters/min of oxygen

Must not have

COVID-19 patients receiving supplemental oxygen with active ventilatory support, CPAP, etc

Individuals with an inherited or acquired blood coagulation disorder, congenital methemoglobinemia, or a familial hemoglobinopathy that impacts oxygen delivery (e.g. sickle cell)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30, 60 days

Summary

This trial is testing a therapy for people with severe symptoms of Covid-19.

Who is the study for?

This trial is for adults aged 18-89 with confirmed COVID-19, experiencing mild respiratory distress and needing more than 4 liters/min of oxygen but not on active ventilatory support. They must be able to consent or have a representative who can. Excluded are pregnant/breastfeeding individuals, those with certain heart/lung/kidney diseases, anemia, taking specific medications that could interact negatively, or at high risk of methemoglobin formation.

What is being tested?

The study tests S-nitrosylation therapy using SNO and nitrogen gas in treating severe acute respiratory syndrome coronavirus (SARS-CoV2) infection. It aims to see if this treatment can help patients breathe better without the need for more intensive breathing support like ventilators.

What are the potential side effects?

Potential side effects may include issues related to inhaling gases such as discomfort or difficulty due to prolonged mask use. There might also be risks associated with nitrosylation therapy itself which aren't specified here but could involve changes in blood chemistry.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can start ENO treatment after my oxygen levels are stable.

Select...

I need more than 4 liters per minute of oxygen to breathe on my own.

Select...

I am between 18 and 89 years old.

Select...

I have mild breathing difficulties.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a COVID-19 patient using extra oxygen or a machine to help me breathe.

Select...

I have a blood disorder that affects clotting or oxygen delivery.

Select...

I am not taking medication that affects blood pressure or oxygen levels.

Select...

I am currently taking nitrates for my condition.

Select...

I am on a heart-lung machine or intubated with a ventilator.

Select...

I have a history of lung cancer, lung removal, or lung transplant.

Select...

I have COVID-19 but little to no trouble breathing.

Select...

I have had a cardiac arrest and received CPR for more than 30 minutes.

Select...

I am a COVID-19 patient needing high levels of oxygen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30, 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30, 60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30, 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of Intubation

Progression to use of ECMO

Treatment Emergent Adverse Events

Secondary study objectives

All-Cause Mortality

Clinical Status

Discontinuation of Oxygen Therapy

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SNOExperimental Treatment1 Intervention

12 patients in the S-nitrosylation arm will receive SNO (six-hour treatment with a sequential increasing dose regimen of 20 ppm x 2 hr, 40 ppm x 2 hr, 80 ppm x 2 hr).

Group II: PlaceboPlacebo Group1 Intervention

12 patients in the placebo arm will receive nitrogen gas (six-hour treatment).

0 / 13Eligibility criteria met