Trial Outcomes & Findings for Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection (NCT NCT05109611)
NCT ID: NCT05109611
Last Updated: 2025-09-25
Results Overview
Confirmed positive COVID-19 test (Both antigen and SARS-CoV-2 RT-PCR acceptable) by Day 28.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1389 participants
Primary outcome timeframe
28 days
Results posted on
2025-09-25
Participant Flow
1393 participants screened; 1389 participants randomized, 4 screen failures due to participants' having a prior history of SARS-CoV-2 infection.
Participant milestones
| Measure |
Nitric Oxide Nasal Spray (NONS)
Participants received NONS for 28 days. 695 participants were randomized, 690 participants received at least one dose. 671 (96.5%) participants were compliant with daily use of therapy.
|
Saline Nasal Spray (PLACEBO)
Participants received PLACEBO for 28 days. 694 participants were randomized, 694 participants received at least one dose. 676 (97.4%) participants were compliant with daily use of therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
690
|
694
|
|
Overall Study
COMPLETED
|
674
|
677
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
Reasons for withdrawal
| Measure |
Nitric Oxide Nasal Spray (NONS)
Participants received NONS for 28 days. 695 participants were randomized, 690 participants received at least one dose. 671 (96.5%) participants were compliant with daily use of therapy.
|
Saline Nasal Spray (PLACEBO)
Participants received PLACEBO for 28 days. 694 participants were randomized, 694 participants received at least one dose. 676 (97.4%) participants were compliant with daily use of therapy.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
10
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
4
|
|
Overall Study
Information unavailable
|
1
|
1
|
Baseline Characteristics
Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection
Baseline characteristics by cohort
| Measure |
Intervention
n=690 Participants
Nitric oxide nasal spray (NONS)
|
Control
n=694 Participants
0.9% Sodium chloride nasal spray
|
Total
n=1384 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
667 Participants
n=5 Participants
|
668 Participants
n=7 Participants
|
1335 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 13.90 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 13.68 • n=7 Participants
|
40.0 years
STANDARD_DEVIATION 13.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
364 Participants
n=5 Participants
|
354 Participants
n=7 Participants
|
718 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
326 Participants
n=5 Participants
|
340 Participants
n=7 Participants
|
666 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
689 Participants
n=5 Participants
|
692 Participants
n=7 Participants
|
1381 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
651 Participants
n=5 Participants
|
652 Participants
n=7 Participants
|
1303 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: 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.
Confirmed positive COVID-19 test (Both antigen and SARS-CoV-2 RT-PCR acceptable) by Day 28.
Outcome measures
| Measure |
Nitric Oxide Releasing Solution
n=690 Participants
Nasal spray with nitric oxide releasing solution (NORS) delivered up to 3 times daily morning, mid-day, and evening; 0.5 mL/dose.
|
Placebo
n=694 Participants
Nasal spray with isotonic saline delivered up to 3 times daily morning, mid-day, and evening; 0.5 mL/dose.
|
|---|---|---|
|
Number of Participants With a COVID-19 Infection.
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: All randomized participants who received at least 1 dose of study intervention (Safety Population)
Hospitalization or ER/ED visits for COVID-19/flu-like symptoms by Day 28.
Outcome measures
| Measure |
Nitric Oxide Releasing Solution
n=690 Participants
Nasal spray with nitric oxide releasing solution (NORS) delivered up to 3 times daily morning, mid-day, and evening; 0.5 mL/dose.
|
Placebo
n=694 Participants
Nasal spray with isotonic saline delivered up to 3 times daily morning, mid-day, and evening; 0.5 mL/dose.
|
|---|---|---|
|
Number of Participants Requiring Medical Services.
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: All randomized participants who received at least 1 dose of study intervention (Safety Population)
Adverse events captured during treatment (i.e., systemic and local nasal/throat events \[emphasis on respiratory and nervous system disorders\]).
Outcome measures
| Measure |
Nitric Oxide Releasing Solution
n=690 Participants
Nasal spray with nitric oxide releasing solution (NORS) delivered up to 3 times daily morning, mid-day, and evening; 0.5 mL/dose.
|
Placebo
n=694 Participants
Nasal spray with isotonic saline delivered up to 3 times daily morning, mid-day, and evening; 0.5 mL/dose.
|
|---|---|---|
|
Number of Participants Reporting Safety Concerns.
|
129 Participants
|
130 Participants
|
Adverse Events
Nitric Oxide Releasing Solution
Serious events: 1 serious events
Other events: 129 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 130 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nitric Oxide Releasing Solution
n=690 participants at risk
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
13 (1.9%) Participants ET due to AEs
|
Placebo
n=694 participants at risk
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%
10 (1.4%) Participants ET due to AEs
|
|---|---|---|
|
Infections and infestations
Hospitalization
|
0.14%
1/690 • Number of events 1 • 35 days.
|
0.00%
0/694 • 35 days.
|
Other adverse events
| Measure |
Nitric Oxide Releasing Solution
n=690 participants at risk
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
13 (1.9%) Participants ET due to AEs
|
Placebo
n=694 participants at risk
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%
10 (1.4%) Participants ET due to AEs
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
7.5%
52/690 • Number of events 52 • 35 days.
|
8.9%
62/694 • Number of events 62 • 35 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
28/690 • Number of events 28 • 35 days.
|
4.9%
34/694 • Number of events 34 • 35 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.0%
21/690 • Number of events 21 • 35 days.
|
3.3%
23/694 • Number of events 23 • 35 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
2.6%
18/690 • Number of events 18 • 35 days.
|
3.2%
22/694 • Number of events 22 • 35 days.
|
|
Nervous system disorders
Headache
|
5.8%
40/690 • Number of events 40 • 35 days.
|
9.9%
69/694 • Number of events 69 • 35 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place