Trial Outcomes & Findings for A Phase II/III Study of Sargramostim (NCT NCT04642950)
NCT ID: NCT04642950
Last Updated: 2024-07-19
Results Overview
Number of days to achieve at least 2-rank improvement on a 7-point ordinal scale from baseline until Day 28.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
70 participants
Primary outcome timeframe
Period until Day 28 (including the case after discharge).
Results posted on
2024-07-19
Participant Flow
Participant milestones
| Measure |
NPC-26
Sargramostim (125 μg) will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment.
|
NP-26 Placebo
Physiological saline will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
23
|
|
Overall Study
COMPLETED
|
44
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
NP-26 Placebo
n=23 Participants
Physiological saline will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment.
|
NPC-26
n=47 Participants
Sargramostim (125 μg) will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=23 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=70 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=23 Participants
|
35 Participants
n=47 Participants
|
56 Participants
n=70 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=23 Participants
|
12 Participants
n=47 Participants
|
14 Participants
n=70 Participants
|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 8.3 • n=23 Participants
|
54.1 years
STANDARD_DEVIATION 12.5 • n=47 Participants
|
54.7 years
STANDARD_DEVIATION 11.3 • n=70 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=23 Participants
|
9 Participants
n=47 Participants
|
18 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=23 Participants
|
38 Participants
n=47 Participants
|
52 Participants
n=70 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
23 participants
n=23 Participants
|
47 participants
n=47 Participants
|
70 participants
n=70 Participants
|
PRIMARY outcome
Timeframe: Period until Day 28 (including the case after discharge).Number of days to achieve at least 2-rank improvement on a 7-point ordinal scale from baseline until Day 28.
Outcome measures
| Measure |
NPC-26
n=47 Participants
Sargramostim (125 μg) will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment.
|
NP-26 Placebo
n=23 Participants
Physiological saline will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment.
|
|---|---|---|
|
2-rank Improvement on a 7-point Ordinal Scale
|
9 Number of Days
Interval 8.0 to 9.0
|
8 Number of Days
Interval 7.0 to 10.0
|
SECONDARY outcome
Timeframe: Period until Day 28 (including the case after discharge).Changes from baseline in alveolar-arterial oxygen partial pressure gradient (A-aDO) on Day 5 and at the end of administration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Period until Day 28 (including the case after discharge).Number of days until discharge from baseline (days of shifting to Category 7 on a 7-point ordinal scale).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Period until Day 28 (including the case after discharge).Proportion of subjects whose category has shifted to Category 1 or 2 on a 7-point ordinal scale from baseline until Day 28
Outcome measures
Outcome data not reported
Adverse Events
NPC-26
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
NP-26 Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NPC-26
n=47 participants at risk
Sargramostim (125 μg) will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment.
Sargramostim: 250 μg/vial of sargramostim will be dissolved in 4 mL of physiological saline and 125 μg of which will be administered using inhaler twice daily in approximately 10-15 minutes.
|
NP-26 Placebo
n=23 participants at risk
Physiological saline will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment.
Placebo: 2 mL of physiological saline will be administered using inhaler twice daily in approximately 10-15 minutes.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
2.1%
1/47 • Day1-28
|
0.00%
0/23 • Day1-28
|
|
Infections and infestations
COVID-19 pneumonia
|
2.1%
1/47 • Day1-28
|
0.00%
0/23 • Day1-28
|
Other adverse events
| Measure |
NPC-26
n=47 participants at risk
Sargramostim (125 μg) will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment.
Sargramostim: 250 μg/vial of sargramostim will be dissolved in 4 mL of physiological saline and 125 μg of which will be administered using inhaler twice daily in approximately 10-15 minutes.
|
NP-26 Placebo
n=23 participants at risk
Physiological saline will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment.
Placebo: 2 mL of physiological saline will be administered using inhaler twice daily in approximately 10-15 minutes.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
14.9%
7/47 • Day1-28
|
17.4%
4/23 • Day1-28
|
|
Hepatobiliary disorders
Hepatocellular injury
|
6.4%
3/47 • Day1-28
|
0.00%
0/23 • Day1-28
|
|
Investigations
White blood cell count increased
|
14.9%
7/47 • Day1-28
|
0.00%
0/23 • Day1-28
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.5%
4/47 • Day1-28
|
4.3%
1/23 • Day1-28
|
|
Psychiatric disorders
Insomnia
|
2.1%
1/47 • Day1-28
|
13.0%
3/23 • Day1-28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place