Trial Outcomes & Findings for Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease (NCT NCT04382924)
NCT ID: NCT04382924
Last Updated: 2021-12-03
Results Overview
1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
168 participants
Primary outcome timeframe
Day 15
Results posted on
2021-12-03
Participant Flow
Participant milestones
| Measure |
Treatment Arm A
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
Standard of Care only
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
56
|
60
|
|
Overall Study
COMPLETED
|
44
|
46
|
48
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
12
|
Reasons for withdrawal
| Measure |
Treatment Arm A
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
Standard of Care only
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
5
|
4
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Transferred to other hospital/declined in person visits
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
6
|
Baseline Characteristics
Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease
Baseline characteristics by cohort
| Measure |
Treatment Arm A
n=52 Participants
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
n=56 Participants
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
n=60 Participants
Standard of Care only
|
Total
n=168 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
59.7 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 13.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
52 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
30 participants
n=5 Participants
|
88 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
12 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Region of Enrollment
Philippines
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
18 participants
n=5 Participants
|
50 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Patient clinical status on WHO 7 point ordinal scale
|
4.23 scores on a scale
STANDARD_DEVIATION 0.425 • n=5 Participants
|
4.25 scores on a scale
STANDARD_DEVIATION 0.548 • n=7 Participants
|
4.25 scores on a scale
STANDARD_DEVIATION 0.437 • n=5 Participants
|
4.24 scores on a scale
STANDARD_DEVIATION 0.471 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: Analysis performed on the number of patients with WHO-7 data
1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death
Outcome measures
| Measure |
Treatment Arm A
n=46 Participants
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
n=44 Participants
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
n=48 Participants
Standard of Care only
|
|---|---|---|---|
|
Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients:
1. Not hospitalized no limitations on activities
|
10 Participants
|
9 Participants
|
18 Participants
|
|
Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients:
2. Not hospitalized but limitations on activities
|
7 Participants
|
9 Participants
|
2 Participants
|
|
Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients:
3. Hospitalized not requiring supplemental O2
|
13 Participants
|
13 Participants
|
16 Participants
|
|
Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients:
4. Hospitalized and requires supplemental O2
|
13 Participants
|
8 Participants
|
7 Participants
|
|
Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients:
5. Hospitalized and on non-invasive ventilation or high flow O2
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients:
6. Hospitalized and on mechanical ventilation or ECMO
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients:
7. Death
|
0 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 1 through 28WHO status of subjects at timepoints from baseline to day 28 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death
Outcome measures
| Measure |
Treatment Arm A
n=52 Participants
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
n=56 Participants
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
n=60 Participants
Standard of Care only
|
|---|---|---|---|
|
Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients
Baseline
|
4.23 scores on a scale
Standard Deviation 0.425
|
4.25 scores on a scale
Standard Deviation 0.548
|
4.25 scores on a scale
Standard Deviation 0.427
|
|
Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients
Day 3
|
4.22 scores on a scale
Standard Deviation 0.503
|
4.22 scores on a scale
Standard Deviation 0.718
|
4.29 scores on a scale
Standard Deviation 0.7063
|
|
Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients
Day 5
|
4.12 scores on a scale
Standard Deviation 0.627
|
4.14 scores on a scale
Standard Deviation 0.917
|
4.18 scores on a scale
Standard Deviation 0.819
|
|
Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients
Day 8
|
3.89 scores on a scale
Standard Deviation 0.767
|
4.02 scores on a scale
Standard Deviation 1.012
|
4.04 scores on a scale
Standard Deviation 0.988
|
|
Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients
Day 11
|
3.87 scores on a scale
Standard Deviation 0.777
|
4.09 scores on a scale
Standard Deviation 1.156
|
3.97 scores on a scale
Standard Deviation 1.098
|
|
Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients
Day 15
|
2.87 scores on a scale
Standard Deviation 1.343
|
2.95 scores on a scale
Standard Deviation 1.628
|
2.96 scores on a scale
Standard Deviation 1.665
|
|
Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients
Day 28
|
1.59 scores on a scale
Standard Deviation 1.384
|
1.80 scores on a scale
Standard Deviation 1.608
|
1.73 scores on a scale
Standard Deviation 1.730
|
SECONDARY outcome
Timeframe: Days 3, 5, 8, 11, 25, 29Population: NEWS score collected on patients currently hospitalized, or returning for follow up visits
National Early Warning Score assessed between baseline and Day 29 on subjects in 20, 40 mg TID NP-120 arms versus control group The National Early Warning Score (NEWS) scale is a composite of 7 physiological parameters: Respiration Rate (per minute),Oxygen Saturations (%), Any Supplemental Oxygen, Temperature (°C), Systolic BP (mmHg), Heart Rate (per minute), Level of Consciousness. The aggregate results from all 7 physiological parameters are used to obtain the NEW Score., ranging from 0 - 20. Higher values reflect a worse outcome.
Outcome measures
| Measure |
Treatment Arm A
n=52 Participants
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
n=56 Participants
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
n=60 Participants
Standard of Care only
|
|---|---|---|---|
|
NEWS Assessed Days 3, 5, 8 ,11 Daily While Hospitalized and on Days 15 and 29 in IP Versus Control Group Patients
Day 3
|
4.2 scores on a scale
Standard Deviation 1.90
|
3.7 scores on a scale
Standard Deviation 1.60
|
4.4 scores on a scale
Standard Deviation 1.91
|
|
NEWS Assessed Days 3, 5, 8 ,11 Daily While Hospitalized and on Days 15 and 29 in IP Versus Control Group Patients
Day 5
|
3.8 scores on a scale
Standard Deviation 2.04
|
3.3 scores on a scale
Standard Deviation 1.95
|
3.7 scores on a scale
Standard Deviation 1.99
|
|
NEWS Assessed Days 3, 5, 8 ,11 Daily While Hospitalized and on Days 15 and 29 in IP Versus Control Group Patients
Day 8
|
3.5 scores on a scale
Standard Deviation 2.33
|
3.1 scores on a scale
Standard Deviation 2.04
|
3.0 scores on a scale
Standard Deviation 2.51
|
|
NEWS Assessed Days 3, 5, 8 ,11 Daily While Hospitalized and on Days 15 and 29 in IP Versus Control Group Patients
Day 15
|
2.4 scores on a scale
Standard Deviation 2.85
|
1.8 scores on a scale
Standard Deviation 2.38
|
1.8 scores on a scale
Standard Deviation 2.37
|
|
NEWS Assessed Days 3, 5, 8 ,11 Daily While Hospitalized and on Days 15 and 29 in IP Versus Control Group Patients
Baseline
|
4.7 scores on a scale
Standard Deviation 1.83
|
4.5 scores on a scale
Standard Deviation 1.58
|
4.5 scores on a scale
Standard Deviation 1.51
|
|
NEWS Assessed Days 3, 5, 8 ,11 Daily While Hospitalized and on Days 15 and 29 in IP Versus Control Group Patients
Day 11
|
3.0 scores on a scale
Standard Deviation 2.21
|
3.0 scores on a scale
Standard Deviation 2.60
|
3.2 scores on a scale
Standard Deviation 2.39
|
|
NEWS Assessed Days 3, 5, 8 ,11 Daily While Hospitalized and on Days 15 and 29 in IP Versus Control Group Patients
Day 29
|
1.1 scores on a scale
Standard Deviation 1.97
|
1.4 scores on a scale
Standard Deviation 2.10
|
1.3 scores on a scale
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: Up to Day 28Rate of mechanical ventilation in 20 and 40 mg TID NP-120 versus control group
Outcome measures
| Measure |
Treatment Arm A
n=52 Participants
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
n=56 Participants
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
n=60 Participants
Standard of Care only
|
|---|---|---|---|
|
Rate of Mechanical Ventilation in IP Versus Control Group Patients
|
5 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to day 28Duration of mechanical ventilation in 20 and 40 mg TID subjects versus control who experience mechanical ventilation
Outcome measures
| Measure |
Treatment Arm A
n=5 Participants
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
n=2 Participants
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
n=4 Participants
Standard of Care only
|
|---|---|---|---|
|
Duration of Mechanical Ventilation (if Applicable) in IP Versus Control Group Patients
< 6 hours
|
0 participants
|
1 participants
|
0 participants
|
|
Duration of Mechanical Ventilation (if Applicable) in IP Versus Control Group Patients
>= 12 hours but < 24 hours
|
0 participants
|
0 participants
|
0 participants
|
|
Duration of Mechanical Ventilation (if Applicable) in IP Versus Control Group Patients
>= 24 hours but <72 hours
|
1 participants
|
0 participants
|
0 participants
|
|
Duration of Mechanical Ventilation (if Applicable) in IP Versus Control Group Patients
>=72 hours but <120 hours
|
0 participants
|
1 participants
|
1 participants
|
|
Duration of Mechanical Ventilation (if Applicable) in IP Versus Control Group Patients
>= 120 hours
|
3 participants
|
0 participants
|
2 participants
|
|
Duration of Mechanical Ventilation (if Applicable) in IP Versus Control Group Patients
Ongoing at time of EOS (>= 24 hours but <72 hours
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to Day 29Duration in patients only receiving supplemental oxygen in IP versus control group up to Day 29
Outcome measures
| Measure |
Treatment Arm A
n=46 Participants
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
n=48 Participants
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
n=52 Participants
Standard of Care only
|
|---|---|---|---|
|
Duration of Supplemental Oxygen in IP Versus Control Group Patients
< 6 hours
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Duration of Supplemental Oxygen in IP Versus Control Group Patients
>= 12 hours but < 24 hours
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Duration of Supplemental Oxygen in IP Versus Control Group Patients
>= 24 hours but < 72 hours
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Duration of Supplemental Oxygen in IP Versus Control Group Patients
>= 72 hours but < 120 hours
|
7 Participants
|
5 Participants
|
8 Participants
|
|
Duration of Supplemental Oxygen in IP Versus Control Group Patients
>= 120 hours
|
35 Participants
|
38 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Up to Day 29Time to return to room pressure (SpO2 \> 94%) on room air in patients in 20, 40 mg TID NP-120 groups versus control group with 94% blood oxygen levels at enrolment Time-to-event endpoints with competing risk were analysed for each dosing group using the Cumulative Incidence Function-CIF (KM) graphical display. Data represents the time (in Days) it took for all participants in the group to return to room pressure air (e.g. the time when the CIF curve hit 100%).
Outcome measures
| Measure |
Treatment Arm A
n=11 Participants
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
n=11 Participants
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
n=13 Participants
Standard of Care only
|
|---|---|---|---|
|
Time to Return to Room Pressure (SpO2 > 94%) on Room Air
|
4 Days
|
5 Days
|
9 Days
|
SECONDARY outcome
Timeframe: Up to Day 29Duration of subject in ICU in 20 and 40 TID mg groups versus control group patients
Outcome measures
| Measure |
Treatment Arm A
n=8 Participants
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
n=6 Participants
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
n=9 Participants
Standard of Care only
|
|---|---|---|---|
|
Duration in ICU (if Applicable) in IP Versus Control Group Patients
Ongoing at end of study
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Duration in ICU (if Applicable) in IP Versus Control Group Patients
>= 1 day but < 3 days
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Duration in ICU (if Applicable) in IP Versus Control Group Patients
>= 21 days
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Duration in ICU (if Applicable) in IP Versus Control Group Patients
>= 3 days but < 7 days
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Duration in ICU (if Applicable) in IP Versus Control Group Patients
>=7 days but < 14 days
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Duration in ICU (if Applicable) in IP Versus Control Group Patients
>=14 days but < 21 days
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Day 29Rate of Overall Mortality in 20, 40 mg TID groups versus control group
Outcome measures
| Measure |
Treatment Arm A
n=52 Participants
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
n=56 Participants
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
n=60 Participants
Standard of Care only
|
|---|---|---|---|
|
Rate of Mortality in IP Versus Control Group Patients
|
2 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 15, 28Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 15, 28Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to day 15, day 28Outcome measures
Outcome data not reported
Adverse Events
Treatment Arm A
Serious events: 2 serious events
Other events: 36 other events
Deaths: 2 deaths
Treatment Arm B
Serious events: 6 serious events
Other events: 35 other events
Deaths: 5 deaths
Control Arm
Serious events: 5 serious events
Other events: 30 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment Arm A
n=52 participants at risk
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
n=56 participants at risk
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
n=60 participants at risk
Standard of Care only
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
3.8%
2/52 • Number of events 2 • From Day 1 to Day 60
|
1.8%
1/56 • Number of events 1 • From Day 1 to Day 60
|
3.3%
2/60 • Number of events 2 • From Day 1 to Day 60
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.00%
0/52 • From Day 1 to Day 60
|
0.00%
0/56 • From Day 1 to Day 60
|
3.3%
2/60 • Number of events 2 • From Day 1 to Day 60
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/52 • From Day 1 to Day 60
|
0.00%
0/56 • From Day 1 to Day 60
|
1.7%
1/60 • Number of events 1 • From Day 1 to Day 60
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/52 • From Day 1 to Day 60
|
1.8%
1/56 • Number of events 1 • From Day 1 to Day 60
|
0.00%
0/60 • From Day 1 to Day 60
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/52 • From Day 1 to Day 60
|
1.8%
1/56 • Number of events 1 • From Day 1 to Day 60
|
1.7%
1/60 • Number of events 1 • From Day 1 to Day 60
|
|
Investigations
Coagulation test abnormal
|
0.00%
0/52 • From Day 1 to Day 60
|
1.8%
1/56 • Number of events 1 • From Day 1 to Day 60
|
0.00%
0/60 • From Day 1 to Day 60
|
|
Nervous system disorders
Seizure
|
0.00%
0/52 • From Day 1 to Day 60
|
1.8%
1/56 • Number of events 1 • From Day 1 to Day 60
|
0.00%
0/60 • From Day 1 to Day 60
|
|
Renal and urinary disorders
Pyelonephritis acute
|
0.00%
0/52 • From Day 1 to Day 60
|
1.8%
1/56 • Number of events 1 • From Day 1 to Day 60
|
0.00%
0/60 • From Day 1 to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/52 • From Day 1 to Day 60
|
1.8%
1/56 • Number of events 1 • From Day 1 to Day 60
|
0.00%
0/60 • From Day 1 to Day 60
|
Other adverse events
| Measure |
Treatment Arm A
n=52 participants at risk
NP-120 (Ifenprodil) 20 mg TID + Standard of Care
|
Treatment Arm B
n=56 participants at risk
NP-120 (Ifenprodil) 40 mg TID + Standard of Care
|
Control Arm
n=60 participants at risk
Standard of Care only
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.8%
2/52 • Number of events 2 • From Day 1 to Day 60
|
5.4%
3/56 • Number of events 3 • From Day 1 to Day 60
|
5.0%
3/60 • Number of events 3 • From Day 1 to Day 60
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
3/52 • Number of events 3 • From Day 1 to Day 60
|
1.8%
1/56 • Number of events 1 • From Day 1 to Day 60
|
5.0%
3/60 • Number of events 3 • From Day 1 to Day 60
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
1/52 • Number of events 1 • From Day 1 to Day 60
|
5.4%
3/56 • Number of events 3 • From Day 1 to Day 60
|
1.7%
1/60 • Number of events 1 • From Day 1 to Day 60
|
|
Gastrointestinal disorders
Nausea
|
5.8%
3/52 • Number of events 3 • From Day 1 to Day 60
|
0.00%
0/56 • From Day 1 to Day 60
|
0.00%
0/60 • From Day 1 to Day 60
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.6%
5/52 • Number of events 5 • From Day 1 to Day 60
|
5.4%
3/56 • Number of events 3 • From Day 1 to Day 60
|
1.7%
1/60 • Number of events 1 • From Day 1 to Day 60
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.8%
3/52 • Number of events 3 • From Day 1 to Day 60
|
3.6%
2/56 • Number of events 2 • From Day 1 to Day 60
|
6.7%
4/60 • Number of events 4 • From Day 1 to Day 60
|
|
Infections and infestations
Oral candidiasis
|
11.5%
6/52 • Number of events 6 • From Day 1 to Day 60
|
5.4%
3/56 • Number of events 3 • From Day 1 to Day 60
|
1.7%
1/60 • Number of events 1 • From Day 1 to Day 60
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/52 • From Day 1 to Day 60
|
5.4%
3/56 • Number of events 3 • From Day 1 to Day 60
|
0.00%
0/60 • From Day 1 to Day 60
|
|
Psychiatric disorders
Anxiety
|
1.9%
1/52 • Number of events 1 • From Day 1 to Day 60
|
8.9%
5/56 • Number of events 5 • From Day 1 to Day 60
|
3.3%
2/60 • Number of events 2 • From Day 1 to Day 60
|
|
Psychiatric disorders
Insomnia
|
3.8%
2/52 • Number of events 2 • From Day 1 to Day 60
|
5.4%
3/56 • Number of events 3 • From Day 1 to Day 60
|
5.0%
3/60 • Number of events 3 • From Day 1 to Day 60
|
|
Hepatobiliary disorders
Hepatocellular injury
|
7.7%
4/52 • Number of events 5 • From Day 1 to Day 60
|
8.9%
5/56 • Number of events 5 • From Day 1 to Day 60
|
13.3%
8/60 • Number of events 8 • From Day 1 to Day 60
|
|
Injury, poisoning and procedural complications
Vessel puncture site bruise
|
5.8%
3/52 • Number of events 4 • From Day 1 to Day 60
|
0.00%
0/56 • From Day 1 to Day 60
|
1.7%
1/60 • Number of events 1 • From Day 1 to Day 60
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/52 • From Day 1 to Day 60
|
7.1%
4/56 • Number of events 4 • From Day 1 to Day 60
|
5.0%
3/60 • Number of events 3 • From Day 1 to Day 60
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
5.8%
3/52 • Number of events 3 • From Day 1 to Day 60
|
0.00%
0/56 • From Day 1 to Day 60
|
0.00%
0/60 • From Day 1 to Day 60
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60