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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30, 60 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Intubation
Progression to use of ECMO
Treatment Emergent Adverse Events
Secondary outcome measures
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).

Find a Location

Who is running the clinical trial?

Robert SchilzLead Sponsor
James ReynoldsLead Sponsor
2 Previous Clinical Trials
80 Total Patients Enrolled
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
259,996 Total Patients Enrolled

Media Library

Nitrogen gas (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04528771 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions commonly require SNO treatment?

"SNO is widely accepted as a treatment for actinic keratosis, but can also be employed to help patients manage respiratory challenge tests, hypoxemia and verruca (warts)."

Answered by AI

What further research has been conducted pertaining to SNO?

"Currently, there are 4 ongoing trials probing SNO with none in the Phase 3 phase. While most of these research projects take place at Stanford University (California), 5 other sites across America are contributing to this investigation as well."

Answered by AI

What are the principal goals of this clinical investigation?

"This trial will assess the Length of Intensive Care over a month-long period, as well as use WHO's 9-point clinical status ordinal scale to measure Time to Clinical Status Improvement and Proportion of patients alive and with discontinued oxygen supportive therapy at day 30. Additionally, it will also evaluate the proportion of participants in each stage at maximum severity on this same scale."

Answered by AI

How many participants are engaging in this clinical research?

"At the present moment, this particular medical trial is not recruiting patients. Initially posted on August 5th 2021 and most recently updated June 20th 2022, no further recruitment will be accepted. If you are searching for other studies involving coronavirus disease 2019 (covid‑19), there are 1056 trials actively enrolling participants; 4 experiments related to SNO also have open enrolment at this time."

Answered by AI

Is the inclusion criterion for this clinical trial limited to adults over 55 years of age?

"This trial is suitable for individuals aged 18 to 89 years. There are 141 clinical trials specifically designed for minors, and 922 additional studies tailored towards senior citizens."

Answered by AI

What restrictions apply to those wishing to participate in this clinical investigation?

"Admission to this medical trial requires the subject be afflicted with coronavirus disease 2019 (covid‑19) and between 18–89 years of age. The total number of participants being sought is 24."

Answered by AI

Is enrollment for this trial still open?

"Unfortunately, according to clinicaltrials.gov this trial is not currently accepting new patients. This research was initially shared on August 5th 2021 and last modified in June 20th 2022. However, there are 1060 other trials that require participants at the moment."

Answered by AI
~6 spots leftby Mar 2025