S-Nitrosylation Therapy for COVID-19

Overseen By Robert Schilz, DO, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Robert Schilz

Must not be taking: Nitrates, PDE-5 inhibitors, others

Disqualifiers: Lung malignancy, Anemia, Pregnancy, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to provide expanded access of S-nitrosylation therapy for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

Research Team

Robert Schilz, DO, PhD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 and can give or have someone to give consent for me.

I am hospitalized with COVID-19 confirmed by a test.

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

Exclusion Criteria

Individuals who are pregnant or breastfeeding

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a 6-hour escalating dose of S-nitrosylation therapy or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

• Nitrogen gas
• SNO

Trial Overview 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.

Participant Groups

Group I: SNO Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Robert Schilz

Lead Sponsor

Trials

1

Recruited

20+

James Reynolds

Lead Sponsor

Trials

3

Recruited

110+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+