Trial Outcomes & Findings for Inhaled Nitric Oxide for Preventing Progression in COVID-19 (NCT NCT04388683)
NCT ID: NCT04388683
Last Updated: 2022-04-19
Results Overview
The clinical disease severity was assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization were those with scores of 1 or 2 (below), and randomization was stratified according to score (1 or 2). Study drug began within 1 hour of randomization. Beginning on the day following randomization ("day 1"), we calculated clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM.
TERMINATED
PHASE2
10 participants
28 days
2022-04-19
Participant Flow
Please note that 9 participants signed consent forms. However, only 8 participants completed the study because the last patient was consented the morning the study was shut down, so they did complete treatment steps or have data collected for them.
Participant milestones
| Measure |
Inhaled Nitric Oxide
Will receive study drug treatment.
Nitric Oxide: Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization ("day 1"), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM.
|
Standard of Care
Will receive standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inhaled Nitric Oxide for Preventing Progression in COVID-19
Baseline characteristics by cohort
| Measure |
Intervention
n=6 Participants
Will receive study drug treatment.
Nitric Oxide: Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization ("day 1"), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM.
|
Control
n=3 Participants
Will receive standard of care.
|
Total
n=9 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
58.9 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Clinical Disease Severity Score
Stage 1
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Clinical Disease Severity Score
Stage 2
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysThe clinical disease severity was assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization were those with scores of 1 or 2 (below), and randomization was stratified according to score (1 or 2). Study drug began within 1 hour of randomization. Beginning on the day following randomization ("day 1"), we calculated clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM.
Outcome measures
| Measure |
Intervention
n=5 Participants
Will receive study drug treatment.
Nitric Oxide: Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization ("day 1"), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM.
|
Control
n=3 Participants
Will receive standard of care.
|
|---|---|---|
|
Number of Participants With Average Maximum Disease Severity Assessed Through 28 Days
Max. Clinical Disease Severity Score : Not receiving O2 Supp.; AND room air O2 saturation >95%
|
1 Participants
|
1 Participants
|
|
Number of Participants With Average Maximum Disease Severity Assessed Through 28 Days
Max. Clinical Disease Severity Score : Supplemental O2 ≤2 liters/min; OR room air O2 saturation ≤94%
|
3 Participants
|
1 Participants
|
|
Number of Participants With Average Maximum Disease Severity Assessed Through 28 Days
Max. Clinical Disease Severity Score : Supplemental nasal O2 >2 & ≤5 liters/min
|
1 Participants
|
0 Participants
|
|
Number of Participants With Average Maximum Disease Severity Assessed Through 28 Days
Max. Clinical Disease Severity Score : HFNC or NIV with FiO2 >50%
|
0 Participants
|
1 Participants
|
|
Number of Participants With Average Maximum Disease Severity Assessed Through 28 Days
HFNC or NIV with FiO2 >50%
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 28 daysThe number of days for participants to reach their maximum clinical disease severity score. Severity score assessed by the following table Stage Oxygen support 0 Not receiving O2 supplementation; AND room air O2 saturation ≥95% 1. Supplemental O2 ≤ 2 liters/min; OR room air O2 saturation ≤ 94% 2. Supplemental nasal O2 \>2 and ≤ 5 liters/min 3. Supplemental nasal O2 \>5 liters/min 4. HFNC or NIV with FiO2 \> 50% 5. Intubation, ECMO, or need to intubate with "Do not intubate" order 6. Death
Outcome measures
| Measure |
Intervention
n=5 Participants
Will receive study drug treatment.
Nitric Oxide: Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization ("day 1"), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM.
|
Control
n=3 Participants
Will receive standard of care.
|
|---|---|---|
|
Days to Maximum Clinical Disease Severity Score
|
1.0 Days
Interval 1.0 to 1.0
|
1 Days
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 28 daysThe number of days for patients to reach maximum severity score from randomization. clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM according to the following table: The following severity score 3 times daily, based on the level of oxygenation / ventilation support, where the treatment target is 92% ≤ O2 saturation \< 96%: Stage Oxygen support 0 Not receiving O2 supplementation; AND room air O2 saturation ≥95% 1. Supplemental O2 ≤ 2 liters/min; OR room air O2 saturation ≤ 94% 2. Supplemental nasal O2 \>2 and ≤ 5 liters/min 3. Supplemental nasal O2 \>5 liters/min 4. HFNC or NIV with FiO2 \> 50% 5. Intubation, ECMO, or need to intubate with "Do not intubate" order 6. Death HFNC = high-flow nasal cannula; NIV = non-invasive ventilation
Outcome measures
| Measure |
Intervention
n=5 Participants
Will receive study drug treatment.
Nitric Oxide: Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization ("day 1"), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM.
|
Control
n=3 Participants
Will receive standard of care.
|
|---|---|---|
|
Days to Maximum Outcome Severity Score
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: 28 daysMaximum outcome severity score
Outcome measures
| Measure |
Intervention
n=5 Participants
Will receive study drug treatment.
Nitric Oxide: Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization ("day 1"), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM.
|
Control
n=3 Participants
Will receive standard of care.
|
|---|---|---|
|
Number of Participants in Each Stage at Maximum Severity
Hospitalized, requiring supp. O2
|
1 Participants
|
1 Participants
|
|
Number of Participants in Each Stage at Maximum Severity
Hospitalized, not requiring supp. O2 or ongoing medical care
|
3 Participants
|
2 Participants
|
|
Number of Participants in Each Stage at Maximum Severity
Not hospitalized, no limitations on activities
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysThe numbers of days a patient spent in the hospital.
Outcome measures
| Measure |
Intervention
n=5 Participants
Will receive study drug treatment.
Nitric Oxide: Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization ("day 1"), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM.
|
Control
n=3 Participants
Will receive standard of care.
|
|---|---|---|
|
Length of Hospital Stay
|
3.0 Days
Interval 3.0 to 9.0
|
3.0 Days
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
Intervention
n=5 Participants
Will receive study drug treatment.
Nitric Oxide: Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization ("day 1"), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM.
|
Control
n=3 Participants
Will receive standard of care.
|
|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
Adverse Events
Intervention
Control
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