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Vasodilator
Nitric Oxide Nasal Spray for COVID-19 Protection
Phase 3
Waitlist Available
Research Sponsored by Sanotize Research and Development corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least aged 18 years old at the time of consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial is testing whether a nasal spray can protect people from COVID-19.
Who is the study for?
This trial is for healthy adults over 18 who can consent and have internet access for telehealth checkups. Women must use contraception if of childbearing potential, and men agree to not donate sperm. Excluded are those with past COVID-19, recent respiratory infections or fever, nasal drug use within 7 days, unstable chronic illnesses, oxygen therapy users, or pregnant/breastfeeding women.Check my eligibility
What is being tested?
The study tests Nitric Oxide Nasal Spray (NONS) against a saline placebo to prevent COVID-19 in at-risk individuals. It's a phase 3 trial where participants are randomly assigned to receive either NONS or placebo without knowing which one they get.See study design
What are the potential side effects?
While the specific side effects of NONS aren't listed here, typical nasal spray reactions may include nasal irritation or discomfort, sneezing, runny nose; systemic effects could potentially arise from nitric oxide but would need clarification from the study details.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
COVID19 (disease)
Secondary outcome measures
Assess tolerability of NONS in participants with all participants including those with COVID-19.
To assess the efficacy of NONS in prevention of severe COVID-19.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Nitric Oxide Releasing SolutionActive Control1 Intervention
Nasal spray with nitric oxide releasing solution (NORS) delivered up to 3 times daily morning, mid-day, and evening.
Maximum volume delivered: 0.56 mL NORS @ 0.11ppm*hrs
Group II: PlaceboPlacebo Group1 Intervention
Nasal spray with isotonic saline delivered up to 3 times daily morning, mid-day, and evening.
Maximum volume delivered: 0.56 mL Saline @ 0.9%
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Who is running the clinical trial?
Sanotize Research and Development corp.Lead Sponsor
8 Previous Clinical Trials
771 Total Patients Enrolled
1 Trials studying COVID-19
306 Patients Enrolled for COVID-19
Keith Moore, PHARMDStudy DirectorSanotize Research and Development corp.
1 Previous Clinical Trials
306 Total Patients Enrolled
1 Trials studying COVID-19
306 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a tracheostomy in the past.I am currently using oxygen therapy.I haven't used any nasal spray medication in the last week.I am a woman who cannot become pregnant or am using birth control.I have had COVID-19 before.I am not pregnant, breastfeeding, or trying to get pregnant.I haven't had a fever, chills, or flu-like symptoms in the last week.I am 18 years old or older.I am a male who is either surgically sterile or will use contraception and not donate sperm.
Research Study Groups:
This trial has the following groups:- Group 1: Nitric Oxide Releasing Solution
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the official stance of the FDA on Nitric Oxide Releasing Solution?
"There is prior clinical data supporting the safety of Nitric Oxide Releasing Solution, so it received a score of 3."
Answered by AI
How many people are signing up to participate in this experiment?
"This study is no longer enrolling patients. The trial was posted on 20/11/2021 and last updated 3/11/2022. However, there are 1864 other studies recruiting patients with communicable diseases and 24 trials for Nitric Oxide Releasing Solution that are still enrolling patients."
Answered by AI
Is this the first time Nitric Oxide Releasing Solution has been tested in a clinical setting?
"At this time, 24 different clinical trials are underway to study the effects of Nitric Oxide Releasing Solution. Of these active studies, 9 have progressed to Phase 3. The largest concentration of research is taking place in Anchorage, Alaska; however, there are 116 total locations running trials for this treatment across the globe."
Answered by AI
Are there any current vacancies in this clinical trial?
"Currently, this clinical trial is not recruiting patients. Based on the information found on clinicaltrials.gov, which was last updated on November 3rd, 2022, the study may be looking for patients in the future. There are 1888 other active trials that are enrolling patients right now."
Answered by AI
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