NCT05109611

Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Phase 3 Clinical Efficacy Study Evaluating Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,389 (actual)
• Sponsor: Sanotize Research and Development corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A multicenter, randomized, double-blinded, placebo-controlled, phase 3 clinical efficacy study evaluating nitric oxide nasal spray (NONS) as prevention for treatment of individuals at risk of exposure to COVID-19 infection.

Detailed description

This is a multicenter, randomized, double-blinded, placebo-controlled, Phase 3 clinical efficacy study evaluating NONS in adult volunteers as a prevention treatment for individuals at risk from COVID-19 infection. Up to 13 000 adult participants aged 18 or over with no known history of SARS-CoV-2 infection will be randomized into one of 2 cohorts of this study in a ratio of 1:1 (Treatment: Placebo Control). Participants with or without underlying medical conditions will be eligible to enroll. The NONS formulation proposed for use in this COVID-19 clinical study will be self-administered at a maximum of 3 times per day, morning, noon, and night for 28 days. Participants will be on study for 4 weeks of treatment (to include 5 days of Screening, 1 week of Follow-Up, participants will be followed for a total of approximately 5 weeks) as a viricidal Investigational Medical Product. Participants will self-administer a nasal spray containing either blinded study treatment or placebo (herein called study treatment). Nitric oxide nasal spray will be delivered from manual pump nasal spray container with 25 mL of solution with each nasal spray dispensing approximately 130-150 µL of solution. After the participant blows their nose, each treatment will require 2 sprays per nostril, or about 0.5 mL per treatment. The primary endpoint is to assess the efficacy of NONS in the prevention of symptomatic COVID-19 infection as determined by a positive COVID-19 test (antigen or reverse-transcriptase polymerase chain reaction \[RT-PCR\]),

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
DRUG	Nitric Oxide	The Sponsor designed a dual chamber nasal spray bottle for NORS administration. Components are mixed from two chambers to create the final NO-producing formulation. The liquid contains NO at 0.11 ppm\*hour, which acts as a viricidal agent. Instructions for storing, preparing, and administering the study treatment will be provided to participants.
DEVICE	Nasal spray with isotonic saline	The Sponsor designed a dual chamber nasal spray bottle for NORS administration. The bottle will be filled with normal saline before being provided to the participant.

Timeline

• Start date: 2021-11-20
• Primary completion: 2024-01-30
• Completion: 2024-04-30
• First posted: 2021-11-05
• Last updated: 2025-09-25
• Results posted: 2025-09-25

Locations

6 sites across 2 countries: Canada, Sri Lanka