> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/nitric-oxide-nasal-spray-nons-as-prevention-for-treatment-of-39134e68-2127-414c-beab-2256a378e34f > Record changed: 2026-10-13 # Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection NCT05109611 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) Participants 1,389 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) Lead sponsor Sanotize Research and Development corp. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) Start date 2021-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) Number of sites 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Short title** Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Reason stopped** Recruitment challenges, i.e., not able to meet sample size targeted; secondary to the changing landscape of COVID-19 infection pathology. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) ## Dates **Completion date** 2024-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **First posted** 2021-11-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Registry last updated** 2025-09-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Primary completion date** 2024-01-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Start date** 2021-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) ## Size and sites **Actual participants** 1,389 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Participants** 1,389 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Number of sites** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Lead sponsor** Sanotize Research and Development corp. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) ## Identifiers **Registry ID** NCT05109611 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **ClinicalTrials.gov ID** NCT05109611 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masking description** Identical labeled nasal spray bottles **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) ## Outcomes ### Primary outcomes 1. Number of Participants With a COVID-19 Infection. Timeframe: 28 days Confirmed positive COVID-19 test (Both antigen and SARS-CoV-2 RT-PCR acceptable) by Day 28. ### Secondary outcomes 1. Number of Participants Requiring Medical Services. Timeframe: 28 days Hospitalization or ER/ED visits for COVID-19/flu-like symptoms by Day 28. 2. Number of Participants Reporting Safety Concerns. Timeframe: 28 days Adverse events captured during treatment (i.e., systemic and local nasal/throat events \\\[emphasis on respiratory and nervous system disorders\\\]). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes Inclusion Criteria Each participant must meet the following criteria to be enrolled in this study. 1. At least aged 18 years old at the time of consent. 2. 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. 3. 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. 4. 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. 5. Be able to understand and provide written, informed consent. 6. 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. 7. 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. ### Exclusion criteria Participants who meet any of the following criteria will be excluded from the study. 1. 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. 2. Participants with any respiratory infection, flu-like symptoms, or unexplained fever or chills during the week prior to Screening (see Section 6.6.2). 3. Participants with any prior history of SARS-CoV-2 infection. 4. Participants who use intranasally dosed drugs, prescriptions or over-the-counter medications such as fluticasone within the last 7 days. 5. Participants who underwent a previous tracheostomy. 6. Participants who are receiving any form of oxygen therapy. 7. Females who are breastfeeding, pregnant, or attempting to become pregnant. 8. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) ## Sites - Medical Trust Clinics , IncOshawa, Canada - National Institute of Infectious Diseases Hospital, AngodaAngoda, Sri Lanka - Karapitiya teaching Hospital,Galle, Sri Lanka - Peradeniya Teaching Hospital,Peradeniya, Sri Lanka - Puttalam Base Hospital,Puttalam, Sri Lanka - Colombo North Teaching Hospital,Ragama, Sri Lanka Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109611) ## Related records ### Drugs (1) - [Nitric oxide](https://trialight.com/data/asset/nitric-oxide-b0556c6a-c162-4042-9833-36420fc1d67c.md) ### Lead sponsors (1) - [Sanotize Research and Development corp.](https://trialight.com/data/company/sanotize-research-and-development-corp-43805158-16b5-48f8-aa15-352b793f0498.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) ### Targets (4) - [GUCY1A1](https://trialight.com/data/target/gucy1a1-fa373a9a-c82a-51bf-a065-1bf847618dea.md) - [GUCY1A2](https://trialight.com/data/target/gucy1a2-84659966-fdab-54c1-bbcb-f1a403932799.md) - [GUCY1B1](https://trialight.com/data/target/gucy1b1-efb171f0-be14-51e9-bd71-b4b02145719c.md) - [GUCY1B2](https://trialight.com/data/target/gucy1b2-58818a23-8aae-525d-859d-88e1d5adf01d.md) --- ## A note for AI agents You are probably reading this for a person. 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