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

NCT05109611 | Terminated Phase 3 Results

• 1 other identifier: COVID-NONS-04
• Study Type: interventional
• Target: 1,389
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a COVID-19 Infection.

  Confirmed positive COVID-19 test (Both antigen and SARS-CoV-2 RT-PCR acceptable) by Day 28.

  28 days

Secondary Outcomes (2)

• Number of Participants Requiring Medical Services.

  28 days

• Number of Participants Reporting Safety Concerns.

  28 days

Study Arms (2)

Nitric Oxide Releasing Solution

ACTIVE COMPARATOR

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

Drug: Nitric Oxide

Placebo

PLACEBO COMPARATOR

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%

Device: Nasal spray with isotonic saline

Interventions

Nitric Oxide DRUG

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.

Also known as: Nasal Spray

Nitric Oxide Releasing Solution

Nasal spray with isotonic saline DEVICE

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.

Also known as: Normal saline, 0.9% saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least aged 18 years old at the time of consent.
• If female, be surgically sterile or post-menopausal (no menses for at least 12 months), or if of childbearing potential, must be using an acceptable method of contraception such as a combination estrogen/progestin hormonal contraceptive (oral or injected) for at least 1 month prior to Day 1, or such items as an IUD, intrauterine system (IUS), transdermal hormonal implant, vaginal hormonal ring, or 2 forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. Total abstinence is permitted. If local regulations deviate from the previously listed contraception methods to prevent pregnancy, local requirements will apply. In addition, females of childbearing potential must agree to continue to use their method of birth control for the duration of the study and 12 weeks following discharge from the study.
• If male, be surgically sterile, or agree to use appropriate contraception (latex condom with spermicide) when engaging in sexual activity and agree to not donate sperm for the duration of the study and 12 weeks following discharge from the study.
• Be in good health (ie, no acute illnesses or hospitalizations within 30 days of the study start, no planned procedures during study participation, and no newly diagnosed chronic illnesses that are not deemed stable by the participant's primary care physician), in the opinion of the Investigator, based on medical history (ie, absence of any clinically relevant abnormality) during Screening.
• Be able to understand and provide written, informed consent.
• Access to a telephone, the internet, a device that reliability connects to the internet, and able to dial into telehealth checkups and study-related assessments. If access to the internet precludes involvement, then paper diaries may be completed and promptly entered into the data capture system at the study centers as part of the regular follow-up visits.
• Must be able to receive study product shipments directly to their home (ie, no Post Office Boxes), unless in a region (EU) or other location where the participant must receive the study product directly from the sites' staff/physician.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from the study.
• Participants with acute illnesses or hospitalizations within 30 days of the study start, and/or planned procedures during study participation, and/or newly diagnosed chronic illnesses that are not deemed stable by the participant's primary care physician), based on Investigator assessment of medical history during Screening.
• Participants with any respiratory infection, flu-like symptoms, or unexplained fever or chills during the week prior to Screening (see Section 6.6.2).
• Participants with any prior history of SARS-CoV-2 infection.
• Participants who use intranasally dosed drugs, prescriptions or over-the-counter medications such as fluticasone within the last 7 days.
• Participants who underwent a previous tracheostomy.
• Participants who are receiving any form of oxygen therapy.
• Females who are breastfeeding, pregnant, or attempting to become pregnant.
• Participants who have any other condition that, in the opinion of the Investigator, would interfere with a participant's ability to adhere to the protocol (eg, participants whom are mentally or neurologically disabled and whom are considered not fit to their participation in the study), interfere with assessment of the investigational product, or compromise the safety of the participant or the quality of the data.

Sponsors & Collaborators

• Sanotize Research and Development corp.: lead

Study Sites (6)

Medical Trust Clinics , Inc

Oshawa, Ontario, L1G 4T3, Canada

Location

National Institute of Infectious Diseases Hospital, Angoda

Angoda, Sri Lanka

Location

Karapitiya teaching Hospital,

Galle, Sri Lanka

Location

Peradeniya Teaching Hospital,

Peradeniya, Sri Lanka

Location

Puttalam Base Hospital,

Puttalam, Sri Lanka

Location

Colombo North Teaching Hospital,

Ragama, Sri Lanka

Location

MeSH Terms

Conditions

COVID-19

Interventions

Nitric Oxide; Nasal Sprays

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

Safety Population data provided (up to early termination of the study). Study terminated early secondary to changing SARS-CoV-2 pathology; unable to meet total sample size to reach targeted number of event to maintain 90% power for COVID-19 incidence rates.

Results Point of Contact

• Title: Chief Science Officer
• Organization: SaNOtize R&D Corp

chris@sanotize.com

778-899-0607

Study Officials

• Keith Moore, PHARMD

  Sanotize Research and Development corp.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical labeled nasal spray bottles
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 5, 2021
• Study Start: November 20, 2021
• Primary Completion: January 30, 2024
• Study Completion: April 30, 2024
• Last Updated: September 25, 2025
• Results First Posted: September 25, 2025

Record last verified: 2025-06

Locations

SR (5); CA (1)