Trial · NCT05109611
Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection
NCT05109611, Phase 3, Terminated, Sanotize Research and Development corp.; results first posted 2025-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection. Trials, record NCT05109611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05109611
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection
- NCT number
- NCT05109611
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,389 participants, actual
- Lead sponsor
- Sanotize Research and Development corp.
- Conditions
- SARS-CoV-2 Infection
- Interventions
- Nitric Oxide, Nasal spray with isotonic saline
- First posted
- 2021-11-05
- Last updated
- 2025-09-25
- Results first posted
- 2025-09-25
- 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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a COVID-19 Infection. | 28 days | Confirmed positive COVID-19 test (Both antigen and SARS-CoV-2 RT-PCR acceptable) by Day 28. |
| Secondary | Number of Participants Requiring Medical Services. | 28 days | Hospitalization or ER/ED visits for COVID-19/flu-like symptoms by Day 28. |
| Secondary | Number of Participants Reporting Safety Concerns. | 28 days | Adverse events captured during treatment (i.e., systemic and local nasal/throat events \[emphasis on respiratory and nervous system disorders\]). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a COVID-19 Infection. | 28 days | All evaluable participants randomized who received at least one dose of the test article (NONS or placebo; mITT) analyzed through the end of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Requiring Medical Services. | 28 days | All randomized participants who received at least 1 dose of study intervention (Safety Population) | participants | NUMBER |
| SECONDARY | Number of Participants Reporting Safety Concerns. | 28 days | All randomized participants who received at least 1 dose of study intervention (Safety Population) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a COVID-19 Infection. | Nitric Oxide Releasing Solution | 2 | Participants | ||
| Number of Participants With a COVID-19 Infection. | Placebo | 2 | Participants | ||
| Number of Participants Requiring Medical Services. | Nitric Oxide Releasing Solution | 1 | participants | ||
| Number of Participants Requiring Medical Services. | Placebo | 0 | participants | ||
| Number of Participants Reporting Safety Concerns. | Nitric Oxide Releasing Solution | 129 | Participants | ||
| Number of Participants Reporting Safety Concerns. | Placebo | 130 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nitric Oxide Nasal Spray (NONS) | 690 | |
| Overall Study | STARTED | Saline Nasal Spray (PLACEBO) | 694 | |
| Overall Study | COMPLETED | Nitric Oxide Nasal Spray (NONS) | 674 | |
| Overall Study | COMPLETED | Saline Nasal Spray (PLACEBO) | 677 | |
| Overall Study | NOT COMPLETED | Nitric Oxide Nasal Spray (NONS) | 16 | |
| Overall Study | NOT COMPLETED | Saline Nasal Spray (PLACEBO) | 17 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Nitric Oxide Releasing Solution | 52 | 690 | 52 |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Placebo | 62 | 694 | 62 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Nitric Oxide Releasing Solution | 28 | 690 | 28 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 34 | 694 | 34 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Nitric Oxide Releasing Solution | 21 | 690 | 21 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Placebo | 23 | 694 | 23 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Nitric Oxide Releasing Solution | 18 | 690 | 18 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Placebo | 22 | 694 | 22 |
| other | Headache | Nervous system disorders | Nitric Oxide Releasing Solution | 40 | 690 | 40 |
| other | Headache | Nervous system disorders | Placebo | 69 | 694 | 69 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nitric Oxide Releasing Solution | 0 | 690 |
| Total, all-cause mortality | Placebo | 0 | 694 |
| Total, other adverse events | Nitric Oxide Releasing Solution | 129 | 690 |
| Total, other adverse events | Placebo | 130 | 694 |
| Total, serious adverse events | Nitric Oxide Releasing Solution | 1 | 690 |
| Total, serious adverse events | Placebo | 0 | 694 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nitric Oxide Releasing Solution vs Placebo: Number of Participants Reporting Safety Concerns. | Trial comparisons |
| Nitric Oxide Releasing Solution vs Placebo: Number of Participants Requiring Medical Services. | Trial comparisons |
| Nitric Oxide Releasing Solution vs Placebo: Number of Participants With a COVID-19 Infection. | Trial comparisons |
| Nitric Oxide Releasing Solution vs Placebo: deaths from any cause | Trial comparisons |
| Nitric Oxide Releasing Solution vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05109611
GET https://conductscience.org/api/trials/v1/NCT05109611/registered