Trial Outcomes & Findings for NO Prevention of COVID-19 for Healthcare Providers (NCT NCT04312243)
NCT ID: NCT04312243
Last Updated: 2026-03-20
Results Overview
Percentage of subjects with COVID-19 diagnosis in the two groups
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
14 days
Results posted on
2026-03-20
Participant Flow
Participant milestones
| Measure |
Treatment Group
Inhaled NO (160 ppm) before and after the work shift. Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.
Inhaled nitric oxide gas: Control group: a SARS-CoV2 rt-PCR will be performed if symptoms arise.
Treatment group: the subjects will breathe NO at the beginning of the shift and before leaving the hospital. Inspired NO will be delivered at 160 parts per million (ppm) for 15 minutes in each cycle. A SARS-CoV-2 rt-PCR will be performed if symptoms arise. Safety: Oxygenation and methemoglobin levels will be monitored via a non-invasive CO-oximeter. If methemoglobin levels rise above 5% at any point of the gas delivery, inhaled NO will be halvened. NO2 gas will be monitored and maintained below 5 ppm.
|
Control Group
Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NO Prevention of COVID-19 for Healthcare Providers
Baseline characteristics by cohort
| Measure |
Treatment Group
n=12 Participants
Inhaled NO (160 ppm) before and after the work shift. Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.
Inhaled nitric oxide gas: Control group: a SARS-CoV2 rt-PCR will be performed if symptoms arise.
Treatment group: the subjects will breathe NO at the beginning of the shift and before leaving the hospital. Inspired NO will be delivered at 160 parts per million (ppm) for 15 minutes in each cycle. A SARS-CoV-2 rt-PCR will be performed if symptoms arise. Safety: Oxygenation and methemoglobin levels will be monitored via a non-invasive CO-oximeter. If methemoglobin levels rise above 5% at any point of the gas delivery, inhaled NO will be halvened. NO2 gas will be monitored and maintained below 5 ppm.
|
Control Group
n=12 Participants
Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 12.7 • n=154 Participants
|
40.2 years
STANDARD_DEVIATION 10.8 • n=151 Participants
|
41.7 years
STANDARD_DEVIATION 11.6 • n=305 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=154 Participants
|
9 Participants
n=151 Participants
|
15 Participants
n=305 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=154 Participants
|
3 Participants
n=151 Participants
|
9 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=154 Participants
|
1 Participants
n=151 Participants
|
1 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
2 Participants
n=305 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=154 Participants
|
11 Participants
n=151 Participants
|
18 Participants
n=305 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
1 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
2 Participants
n=305 Participants
|
|
BMI
|
28.9 kg/m2
STANDARD_DEVIATION 5.57 • n=154 Participants
|
28.8 kg/m2
STANDARD_DEVIATION 5.18 • n=151 Participants
|
28.8 kg/m2
STANDARD_DEVIATION 5.26 • n=305 Participants
|
|
Smoking Status
Current Smoker
|
1 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
1 Participants
n=305 Participants
|
|
Smoking Status
Former Smoker
|
2 Participants
n=154 Participants
|
3 Participants
n=151 Participants
|
5 Participants
n=305 Participants
|
|
Smoking Status
Never Smoked
|
9 Participants
n=154 Participants
|
9 Participants
n=151 Participants
|
18 Participants
n=305 Participants
|
|
Hypertension
|
2 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
2 Participants
n=305 Participants
|
|
Diabetes
|
2 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
2 Participants
n=305 Participants
|
|
Asthma
|
1 Participants
n=154 Participants
|
1 Participants
n=151 Participants
|
2 Participants
n=305 Participants
|
PRIMARY outcome
Timeframe: 14 daysPercentage of subjects with COVID-19 diagnosis in the two groups
Outcome measures
| Measure |
Treatment Group
n=12 Participants
Inhaled NO (160 ppm) before and after the work shift. Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.
Inhaled nitric oxide gas: Control group: a SARS-CoV2 rt-PCR will be performed if symptoms arise.
Treatment group: the subjects will breathe NO at the beginning of the shift and before leaving the hospital. Inspired NO will be delivered at 160 parts per million (ppm) for 15 minutes in each cycle. A SARS-CoV-2 rt-PCR will be performed if symptoms arise. Safety: Oxygenation and methemoglobin levels will be monitored via a non-invasive CO-oximeter. If methemoglobin levels rise above 5% at any point of the gas delivery, inhaled NO will be halvened. NO2 gas will be monitored and maintained below 5 ppm.
|
Control Group
n=12 Participants
Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.
|
|---|---|---|
|
COVID-19 Diagnosis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 daysPercentage of subjects with a positive test in the two groups
Outcome measures
| Measure |
Treatment Group
n=12 Participants
Inhaled NO (160 ppm) before and after the work shift. Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.
Inhaled nitric oxide gas: Control group: a SARS-CoV2 rt-PCR will be performed if symptoms arise.
Treatment group: the subjects will breathe NO at the beginning of the shift and before leaving the hospital. Inspired NO will be delivered at 160 parts per million (ppm) for 15 minutes in each cycle. A SARS-CoV-2 rt-PCR will be performed if symptoms arise. Safety: Oxygenation and methemoglobin levels will be monitored via a non-invasive CO-oximeter. If methemoglobin levels rise above 5% at any point of the gas delivery, inhaled NO will be halvened. NO2 gas will be monitored and maintained below 5 ppm.
|
Control Group
n=12 Participants
Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.
|
|---|---|---|
|
Positive SARS-CoV-2 Rt-PCR Test
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 daysMean/ Median in the two groups
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 daysPercentage in the two groups
Outcome measures
Outcome data not reported
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place