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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

Must not have

Participants who underwent a previous tracheostomy

Participants who are receiving any form of oxygen therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

Pivotal Trial

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.

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.

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 below

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I am 18 years old or older.

Exclusion Criteria

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

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I have had a tracheostomy in the past.

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I am currently using oxygen therapy.

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I haven't used any nasal spray medication in the last week.

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I have had COVID-19 before.

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I am not pregnant, breastfeeding, or trying to get pregnant.

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I haven't had a fever, chills, or flu-like symptoms in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 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

COVID19 (disease)

Secondary study objectives

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.

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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%

0 / 7Eligibility criteria met