Trial Outcomes & Findings for Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive. (NCT NCT05785390)
NCT ID: NCT05785390
Last Updated: 2026-08-13
Results Overview
Number of DLTS (Dose Limiting Toxicities) in the NP-101 arm at each dose compared to placebo and the safety threshold. This outcome measure ONLY APPLIES TO the Phase-IIa (Dose-finding) component of the trial.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
170 participants
Primary outcome timeframe
Fourteen days per dose (Phase IIA Only)
Results posted on
2026-08-13
Participant Flow
60 participants were enrolled during the Phase-IIa component of the trial during which we identified the Phase-IIb dose. The remaining 110 participants were enrolled on the study during the Phase-IIb component.
Participant eligibility was checked at the time of screening. If the date of randomization is not the same day of screening, the eligibility was checked again before randomization.
Participant milestones
| Measure |
Phase-IIa NP-101, Dose 3g
This is the cohort receiving NP-101 at Dose 3g during the dose finding Phase-IIa component
|
Phase-IIa Placebo, Dose 3g
This is the cohort receiving Placebo at Dose 3g during the dose finding Phase-IIa component
|
Phase-IIa NP-101, Dose 4.8g
This is the cohort receiving NP-101 at Dose 4.8g during the dose finding Phase-IIa component
|
Phase-IIa Placebo, Dose 4.8g
This is the cohort receiving Placebo at Dose 4.8g during the dose finding Phase-IIa component
|
Phase-IIa NP-101, Dose 6g
This is the cohort receiving NP-101 at Dose 6g during the dose finding Phase-IIa component
|
Phase-IIa Placebo, Dose 6g
This is the cohort receiving Placebo at Dose 6g during the dose finding Phase-IIa component
|
Phase-IIb NP-101, Dose 6g
This is the cohort receiving the Phase-II Dose of 6g NP-101during the dose finding Phase-IIb component
|
Phase-IIb Placebo, Dose 6g
This is the cohort receiving the Phase-II Dose of 6g Placebo during the efficacy Phase-IIb component
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
5
|
15
|
5
|
15
|
5
|
50
|
60
|
|
Overall Study
COMPLETED
|
15
|
5
|
15
|
5
|
15
|
5
|
50
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive.
Baseline characteristics by cohort
| Measure |
Phase-IIb NP-101, Dose 6g
n=50 Participants
This is the cohort receiving NP-101 at the Phase-II dose of 6g during the efficacy Phase-IIb component
|
Phase-IIb Placebo, Dose 6g
n=60 Participants
This is the cohort receiving Placebo at the Phase-II dose of 6g during the efficacy Phase-IIb component
|
Total
n=170 Participants
Total of all reporting groups
|
Phase-IIa NP-101, Dose 6g
n=15 Participants
This is the cohort receiving NP-101 at Dose 4.8g during the dose finding Phase-IIa component
|
Phase-IIa Placebo, Dose 6g
n=5 Participants
This is the cohort receiving Placebo at Dose 6g during the dose finding Phase-IIa component
|
Phase-IIa NP-101, Dose 3g
n=15 Participants
This is the cohort receiving tNP-101 at Dose 3g during the dose finding Phase-IIa component
|
Phase-IIa Placebo, Dose 3g
n=5 Participants
This is the cohort receiving Placebo at Dose 3g during the dose finding Phase-IIa component
|
Phase-IIa NP-101, Dose 4.8g
n=15 Participants
This is the cohort receiving NP-101 at Dose 4.8g during the dose finding Phase-IIa component
|
Phase-IIa Placebo, Dose 4.8g
n=5 Participants
This is the cohort receiving Placebo at Dose 4.8g during the dose finding Phase-IIa component
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.04 Year
STANDARD_DEVIATION 14.14 • n=82 Participants
|
43.84 Year
STANDARD_DEVIATION 14.07 • n=78 Participants
|
44.59 Year
STANDARD_DEVIATION 14.49 • n=81 Participants
|
42.53 Year
STANDARD_DEVIATION 13.93
|
47.58 Year
STANDARD_DEVIATION 19.13 • n=5 Participants
|
41.53 Year
STANDARD_DEVIATION 14.03 • n=1 Participants
|
41.05 Year
STANDARD_DEVIATION 7.95 • n=1 Participants
|
47.54 Year
STANDARD_DEVIATION 14.72 • n=1 Participants
|
45.51 Year
STANDARD_DEVIATION 28.22 • n=2 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=82 Participants
|
38 Participants
n=78 Participants
|
116 Participants
n=81 Participants
|
12 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
8 Participants
n=1 Participants
|
3 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=82 Participants
|
22 Participants
n=78 Participants
|
54 Participants
n=81 Participants
|
3 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=1 Participants
|
4 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=82 Participants
|
2 Participants
n=78 Participants
|
2 Participants
n=81 Participants
|
0 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=82 Participants
|
2 Participants
n=78 Participants
|
9 Participants
n=81 Participants
|
1 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=82 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=81 Participants
|
0 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=82 Participants
|
7 Participants
n=78 Participants
|
20 Participants
n=81 Participants
|
2 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=82 Participants
|
34 Participants
n=78 Participants
|
94 Participants
n=81 Participants
|
4 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=82 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=81 Participants
|
0 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=82 Participants
|
15 Participants
n=78 Participants
|
45 Participants
n=81 Participants
|
8 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=82 Participants
|
48 Participants
n=78 Participants
|
127 Participants
n=81 Participants
|
8 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
10 Participants
n=1 Participants
|
4 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=82 Participants
|
12 Participants
n=78 Participants
|
43 Participants
n=81 Participants
|
7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=82 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=81 Participants
|
0 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Fourteen days per dose (Phase IIA Only)Population: This is the dose-escalation cohort treated with NP-101. The trial also had 5 placebo participants at each dose level, who did not have any DLTs, either. Based on the toxicity profiles, the study DSMB recommended the highest dose level, namely, 6g daily dose of NP-101, as the Phase-IIb efficacy dose.
Number of DLTS (Dose Limiting Toxicities) in the NP-101 arm at each dose compared to placebo and the safety threshold. This outcome measure ONLY APPLIES TO the Phase-IIa (Dose-finding) component of the trial.
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=15 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=15 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
n=15 Participants
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Establishment of MTDD
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through Day 45Population: This outcome measure includes both Phase-IIa arms (a total of six arms) and Phase-IIb arms (two arms)
Evaluation of the number of overall adverse events, related adverse reactions, adverse events leading to discontinuation of study drug, hospitalization, or death.
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=5 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=15 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
n=15 Participants
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
n=5 Participants
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
n=15 Participants
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
n=5 Participants
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
n=50 Participants
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
n=60 Participants
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of NP-101 vs Placebo (Phase IIa and IIb)
Number of Patients with adverse events (AE) leading to d/c of study drug, hospitalization or death.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of NP-101 vs Placebo (Phase IIa and IIb)
Number of Participants with Adverse Events (AE) attributable to the study madication
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
8 Participants
|
12 Participants
|
|
Safety and Tolerability of NP-101 vs Placebo (Phase IIa and IIb)
Number of Participants with Adverse Events (AE) regardless of attribution
|
3 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
12 Participants
|
4 Participants
|
19 Participants
|
32 Participants
|
|
Safety and Tolerability of NP-101 vs Placebo (Phase IIa and IIb)
Number of Patients with serious adverse events (SAE) attributable to the study medication
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of NP-101 vs Placebo (Phase IIa and IIb)
No. of Patients with serious adverse events (SAE) regardless of attributable to the study medication
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through Day 5Population: This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. The analysis cohort includes all Phase-IIb participants.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. This outcome measure is defined as the difference of Sustained Clinical Recovery (SCR) rates on Day 5 in patients taking the MTDD of NP-101 vs Placebo.
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=60 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=50 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Time to Sustained Clinical Recovery
|
36 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Enrollment to Day-7 on studyPopulation: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. Baseline RT-PCR assessment was available for 46 patients in the NP-101 arm and 59 for the Phasebo arm. On Day-7, RT-PCR test was positive for 5 participants in NP-101 arm and 8 participants in the Placebo arm. Therefore, our comparison sample size for this aim is only 5 and 8 participants, respectively for NP-101 and Placebo, having both the baseline and Day-7 measurements.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. With this outcome measure, we aim to compare the change in viral load and cycle threshold profiles from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. As Viral Load and Cycle Threshold values were not available on Day-14 as the RT-PCR assessment of Covid-19 was negative, we are able to provide the change only from Baseline to Day-7.
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=8 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=5 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Difference of Change in Log2 of Viral Load From Baseline to Day-7 Between NP-101 and Placebo
|
9.63 Log-2 of the number of copies/mL
Standard Deviation 4.43
|
5.11 Log-2 of the number of copies/mL
Standard Deviation 7.09
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Enrollment to Day-7Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. Baseline RT-PCR assessment was available for 46 patients in the NP-101 arm and 59 for the Phasebo arm. On Day-7, RT-PCR test was positive for 5 participants in NP-101 arm and 8 participants in the Placebo arm. Therefore, our comparison sample size for this aim is only 5 and 8 participants, respectively for NP-101 and Placebo, having both the baseline and Day-7 measurements.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. With this outcome measure, we aim to compare the change in viral load and cycle threshold profiles from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. As Viral Load and Cycle Threshold values were not available on Day-14 as the RT-PCR assessment of Covid-19 was negative, we are able to provide the change only from Baseline to Day-7
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=8 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=5 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Difference of Change in ORF1 Gene From Baseline to Day-7 Between NP-101 and Placebo
|
10.08 No of amplification cycles for detection
Standard Deviation 4.64
|
5.35 No of amplification cycles for detection
Standard Deviation 7.34
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Enrollment to Day-7Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. Baseline RT-PCR assessment was available for 46 patients in the NP-101 arm and 59 for the Phasebo arm. On Day-7, RT-PCR test was positive for 5 participants in NP-101 arm and 8 participants in the Placebo arm. Therefore, our comparison sample size for this aim is only 5 and 8 participants, respectively for NP-101 and Placebo, having both the baseline and Day-7 measurements
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. With this outcome measure, we aim to compare the change in viral load and cycle threshold profiles from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. As Viral Load and Cycle Threshold values were not available on Day-14 as the RT-PCR assessment of Covid-19 was negative, we are able to provide the change only from Baseline to Day-7.
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=8 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=5 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Difference in Change of E-Gene From Baseline to Day-7 Between N101 and Placebo
|
10.14 No of amplification cycles for detection
Standard Deviation 5.01
|
4.92 No of amplification cycles for detection
Standard Deviation 7.76
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From enrollment to Day-7Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. Baseline RT-PCR assessment was available for 46 patients in the NP-101 arm and 59 for the Phasebo arm. On Day-7, RT-PCR test was positive for 5 participants in NP-101 arm and 8 participants in the Placebo arm. Therefore, our comparison sample size for this aim is only 5 and 8 participants, respectively for NP-101 and Placebo, having both the baseline and Day-7 measurements
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. . With this outcome measure, we aim to compare the change in viral load and cycle threshold profiles from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. As Viral Load and Cycle Threshold values were not available on Day-14 as the RT-PCR assessment of Covid-19 was negative, we are able to provide the change only from Baseline to Day-7.
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=8 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=5 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Differenc in Change of N-Gene From Baseline to Day-7 Between NP-101 and Placebo
|
9.79 No of amplification cycles for detection
Standard Deviation 4.00
|
5.78 No of amplification cycles for detection
Standard Deviation 7.26
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 0 to 7Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. RT-PCR results were conclusive only for 46 participants in the NP-101 arm and 54 participants in the Placebo arm.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. In this objective, we aim to compare the percentage of RT-PCR negative/undetectable (i.e., viral clearance) on Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=54 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=42 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
RT-PCR Negative/Undetectable Rate at Day 7
|
46 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day-14Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. RT-PCR results were conclusive on Day-14 for 47 NP-101 and 54 placebo participants.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. In this objective, we aim to compare the percentage of RT-PCR negative/undetectable (i.e., viral clearance) on Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=54 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=47 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
RT-PCR Negative/Undetectable on Day-14
|
54 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day-0 to Day-28Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. All enrolled and randomized patients had at least minimal symptoms data and were included in this outcome measure.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. In this aim, we compare the median days from randomization to the attainment of Sustained Clinical Recovery between NP-101 and Placebo arms
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=60 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=50 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Median Time to Sustained Clinical Recovery
|
4 Days from enrollment
Interval 4.0 to 5.0
|
5 Days from enrollment
Interval 4.0 to 5.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day-0 to Day-28Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. All enrolled and randomized patients had at least minimal symptoms data and were included in this outcome measure.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. In this aim, we compare the median days from randomization to the attainment of Sustained Clinical Recovery between NP-101 and Placebo arms
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=60 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=50 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Median Day to Complete Clinical Recovery
|
20.5 Days from Enrollment
Interval 12.0 to 25.0
|
18 Days from Enrollment
Interval 7.0 to 23.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day-0 to Day-28Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. All enrolled and randomized patients had at least minimal symptoms data and were included in this outcome measure.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. In this aim, we compare the median days from randomization to the attainment of the complete clinical resolution between NP-101 and Placebo.
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=60 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=50 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Median Days to Complete Clinical Resolution
|
23.5 Days from Enrollment
Interval 16.0 to 27.0
|
19 Days from Enrollment
Interval 11.0 to 27.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day-0 to Day-7Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. This is the full analysis set of the study. From the NP-101 arms, flow cytometry assessment was not available for two patients, thus reducing the number of participants from 50 to 48.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. In this objective, we aim to compare the change in effector immune cells, specifically CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. We have a total of 36 markers for CD4+ and CD8+ Flow cytometry markers are combinations of the following immune cell types having various immune responses singly or in combination: CD3, CD5, CD8, CD16, CD19, CD45, CCR7, and CXCR3. The flow-cytomerty markers include the immune cell types: CD3, CD4, CD8, CD16, CD19, CD45, CCR7, and CXCR3. Markers are absolute counts of cells per cubic milimeter.
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=60 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=48 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45+ CCR7 CD8⁺ (Absolute Count as cells/mm^3)
|
553.27 Counts of cells/mm^3
Standard Deviation 317.40
|
648.10 Counts of cells/mm^3
Standard Deviation 362.76
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CCR7⁺ CD8⁺ (Absolute Count as cells/mm^3)
|
750.81 Counts of cells/mm^3
Standard Deviation 505.66
|
647.75 Counts of cells/mm^3
Standard Deviation 411.72
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CXCR3⁺ CD4⁺ (Absolute Count as cells/mm^3)
|
130.01 Counts of cells/mm^3
Standard Deviation 141.1
|
125.86 Counts of cells/mm^3
Standard Deviation 153.98
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CCR7⁺ CXCR3⁺ CD8⁺ (Absolute Count as cells/mm^3)
|
14.17 Counts of cells/mm^3
Standard Deviation 15.66
|
16.80 Counts of cells/mm^3
Standard Deviation 26.67
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CXCR3⁺ CD8⁺ (Absolute Count as cells/mm^3)
|
1496.86 Counts of cells/mm^3
Standard Deviation 518.6
|
1573.88 Counts of cells/mm^3
Standard Deviation 609.67
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD8⁺ CD4⁺ (Absolute Count as cells/mm^3)
|
19.05 Counts of cells/mm^3
Standard Deviation 17.12
|
21.96 Counts of cells/mm^3
Standard Deviation 32.77
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CCR7⁺ CXCR3⁺ CD4⁺ (Absolute Count as cells/mm^3)
|
110.59 Counts of cells/mm^3
Standard Deviation 124.01
|
109.06 Counts of cells/mm^3
Standard Deviation 130.88
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD8⁺ (Absolute Count as cells/mm^3)
|
530.17 Counts of cells/mm^3
Standard Deviation 240.16
|
544.13 Counts of cells/mm^3
Standard Deviation 235.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD4⁺ (Absolute Count as cells/mm^3)
|
1018.03 Counts of cells/mm^3
Standard Deviation 381.23
|
1051.97 Counts of cells/mm^3
Standard Deviation 398.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45_LYMPHOGATE (Absolute Count as cells/mm^3)
|
2198.00 Counts of cells/mm^3
Standard Deviation 655.61
|
2256.04 Counts of cells/mm^3
Standard Deviation 738.12
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7⁺ CD8⁺ (Absolute Count as cells/mm^3)
|
175.87 Counts of cells/mm^3
Standard Deviation 179.88
|
181.45 Counts of cells/mm^3
Standard Deviation 146.63
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CCR7⁺ CD4⁺ (Absolute Count as cells/mm^3)
|
954.23 Counts of cells/mm^3
Standard Deviation 479.38
|
942.70 Counts of cells/mm^3
Standard Deviation 400.62
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7 CD4⁺ (Absolute Count as cells/mm^3)
|
286.70 Counts of cells/mm^3
Standard Deviation 202.4
|
297.09 Counts of cells/mm^3
Standard Deviation 238.68
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CCR7 CD8⁺ (Absolute Count as cells/mm^3)
|
737.71 Counts of cells/mm^3
Standard Deviation 401.83
|
778.96 Counts of cells/mm^3
Standard Deviation 457.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD16⁺ (Absolute Count as cells/mm^3)
|
262.09 Counts of cells/mm^3
Standard Deviation 135.68
|
260.96 Counts of cells/mm^3
Standard Deviation 142.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7⁺ CD4⁺ (Absolute Count as cells/mm^3)
|
903.43 Counts of cells/mm^3
Standard Deviation 411.39
|
945.41 Counts of cells/mm^3
Standard Deviation 464.32
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD19⁺ (Absolute Count as cells/mm^3)
|
314.21 Counts of cells/mm^3
Standard Deviation 134.1
|
323.79 Counts of cells/mm^3
Standard Deviation 143.12
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ (Absolute Count as cells/mm^3)
|
1592.98 Counts of cells/mm^3
Standard Deviation 512.35
|
1640.57 Counts of cells/mm^3
Standard Deviation 577.19
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7 CD8⁺ (Absolute Count as cells/mm^3)
|
33.94 Counts of cells/mm^3
Standard Deviation 15.95
|
34.64 Counts of cells/mm^3
Standard Deviation 17.68
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day-0 to Day-7Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. This is the full analysis set of the study. From the NP-101 arms, flow cytometry assessment was not available for two patients, thus reducing the number of participants from 50 to 48.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. In this objective, we aim to compare the change in the ratio of CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. Both CD4+ and CD8+ are measured as absolute counts of cells per cubic milimeter.
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=60 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=48 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Difference of the Change From Randomization to Day-7 ın the Ratio of the Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
|
2.17 Ratio
Standard Deviation 1.19
|
2.11 Ratio
Standard Deviation 0.83
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day-0 to Day-7 Cell PercentagesPopulation: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. This is the full analysis set of the study. From the NP-101 arms, flow cytometry assessment was not available for two patients, thus reducing the number of participants from 50 to 48.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. In this objective, we aim to compare the change in effector immune cells, specifically CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. We have a total of 36 markers for CD4+ and CD8+ Flow cytometry markers are combinations of the following immune cell types having various immune responses singly or in combination: CD3, CD5, CD8, CD16, CD19, CD45, CCR7, and CXCR3. The flow-cytomerty markers include the immune cell types: CD3, CD4, CD8, CD16, CD19, CD45, CCR7, and CXCR3. These marker entries represent the percentages of the combination of these immune cell types or their percentages in the biological sample.
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=60 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=48 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CXCR3⁺ CD8⁺ (%)
|
-1.21 Percentage (%)
Standard Deviation 8.31
|
0.58 Percentage (%)
Standard Deviation 9.74
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7 CD8⁺ (%)
|
-0.29 Percentage (%)
Standard Deviation 9.77
|
0.99 Percentage (%)
Standard Deviation 8.62
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CXCR3⁺ CD4⁺ (%)
|
-0.27 Percentage (%)
Standard Deviation 7.59
|
-0.35 Percentage (%)
Standard Deviation 9.95
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CCR7⁺ CXCR3⁺ CD8⁺ (%)
|
0.04 Percentage (%)
Standard Deviation 6.30
|
-0.29 Percentage (%)
Standard Deviation 6.83
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7⁺ CD8⁺ (%)
|
-1.99 Percentage (%)
Standard Deviation 7.50
|
-0.50 Percentage (%)
Standard Deviation 10.43
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CCR7⁺ CXCR3⁺ CD4⁺ (%)
|
-0.32 Percentage (%)
Standard Deviation 1.81
|
-0.06 Percentage (%)
Standard Deviation 1.36
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD8⁺ CD4⁺ (%)
|
-0.08 Percentage (%)
Standard Deviation 0.45
|
0.01 Percentage (%)
Standard Deviation 0.88
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD16⁺ (%)
|
-1.43 Percentage (%)
Standard Deviation 6.19
|
-0.94 Percentage (%)
Standard Deviation 4.67
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD4⁺(%)
|
0.06 Percentage (%)
Standard Deviation 3.76
|
0.04 Percentage (%)
Standard Deviation 4.11
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7⁺ CD4⁺ (%)
|
0.34 Percentage (%)
Standard Deviation 11.30
|
-0.49 Percentage (%)
Standard Deviation 9.27
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD8⁺ (%)
|
1.04 Percentage (%)
Standard Deviation 6.47
|
-0.05 Percentage (%)
Standard Deviation 3.18
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CCR7 CD8⁺ (%)
|
1.95 Percentage (%)
Standard Deviation 3.59
|
0.02 Percentage (%)
Standard Deviation 5.33
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ (%)
|
-0.52 Percentage (%)
Standard Deviation 6.34
|
0.22 Percentage (%)
Standard Deviation 4.82
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD19⁺ (%)
|
1.83 Percentage (%)
Standard Deviation 3.03
|
0.62 Percentage (%)
Standard Deviation 2.67
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CCR7⁺ CD4⁺ (%)
|
0.34 Percentage (%)
Standard Deviation 11.30
|
-0.49 Percentage (%)
Standard Deviation 9.27
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7 CD4⁺ (%)
|
2.10 Percentage (%)
Standard Deviation 8.24
|
0.26 Percentage (%)
Standard Deviation 8.61
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day*0 to Day-14Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. This is the full analysis set of the study. From the NP-101 arms, flow cytometry assessment was not available for one patient, thus reducing the number of participants from 50 to 49.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. In this objective, we aim to compare the change in effector immune cells, specifically CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. We have a total of 36 markers for CD4+ and CD8+. Flow cytometry markers are combinations of the following immune cell types having various immune responses singly or in combination: CD3, CD5, CD8, CD16, CD19, CD45, CCR7, and CXCR3. The flow-cytomerty markers include the immune cell types: CD3, CD4, CD8, CD16, CD19, CD45, CCR7, and CXCR3. Markers are absolute count of cells per cubic milimeter.
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=60 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=49 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45+ CCR7 CD8⁺ (Absolute Count as cells/mm^3)
|
568.31 cells/mm^3
Standard Deviation 329.50
|
630.96 cells/mm^3
Standard Deviation 348.84
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CCR7⁺ CD8⁺ (Absolute Count as cells/mm^3)
|
678.60 cells/mm^3
Standard Deviation 448.71
|
627.99 cells/mm^3
Standard Deviation 401.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CCR7⁺ CXCR3⁺ CD8⁺ (Absolute Count as cells/mm^3)
|
14.84 cells/mm^3
Standard Deviation 18.14
|
16.61 cells/mm^3
Standard Deviation 29.77
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CXCR3⁺ CD8⁺ (Absolute Count as cells/mm^3)
|
1485.02 cells/mm^3
Standard Deviation 506.68
|
1560.93 cells/mm^3
Standard Deviation 521.79
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD8⁺ CD4⁺ (Absolute Count as cells/mm^3)
|
20.10 cells/mm^3
Standard Deviation 17.94
|
18.82 cells/mm^3
Standard Deviation 16.67
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CCR7⁺ CXCR3⁺ CD4⁺ (Absolute Count as cells/mm^3)
|
106.19 cells/mm^3
Standard Deviation 89.02
|
103.07 cells/mm^3
Standard Deviation 123.04
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD8⁺ (Absolute Count as cells/mm^3)
|
496.46 cells/mm^3
Standard Deviation 219.66
|
524.73 cells/mm^3
Standard Deviation 215.27
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD4⁺ (Absolute Count as cells/mm^3)
|
963.24 cells/mm^3
Standard Deviation 403.13
|
1018.27 cells/mm^3
Standard Deviation 396.09
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45_LYMPHOGATE (Absolute Count as cells/mm^3)
|
2075.25 cells/mm^3
Standard Deviation 665.69
|
2219.08 cells/mm^3
Standard Deviation 687.91
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7⁺ CD8⁺ (Absolute Count as cells/mm^3)
|
146.68 cells/mm^3
Standard Deviation 107.73
|
168.47 cells/mm^3
Standard Deviation 125.91
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CCR7⁺ CD4⁺ (Absolute Count as cells/mm^3)
|
912.86 cells/mm^3
Standard Deviation 445.05
|
924.25 cells/mm^3
Standard Deviation 345.16
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7 CD4⁺ (Absolute Count as cells/mm^3)
|
266.41 cells/mm^3
Standard Deviation 181.75
|
278.61 cells/mm^3
Standard Deviation 168.56
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CCR7 CD8⁺ (Absolute Count as cells/mm^3)
|
672.74 cells/mm^3
Standard Deviation 362.52
|
775.97 cells/mm^3
Standard Deviation 401.74
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD16⁺ (Absolute Count as cells/mm^3)
|
252.65 cells/mm^3
Standard Deviation 137.30
|
662.39 cells/mm^3
Standard Deviation 2851.03
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7⁺ CD4⁺ (Absolute Count as cells/mm^3)
|
841.36 cells/mm^3
Standard Deviation 426.28
|
937.05 cells/mm^3
Standard Deviation 440.55
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD19⁺ (Absolute Count as cells/mm^3)
|
288.91 cells/mm^3
Standard Deviation 125.42
|
325.93 cells/mm^3
Standard Deviation 135.74
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ (Absolute Count as cells/mm^3)
|
1501.06 cells/mm^3
Standard Deviation 522.98
|
1587.71 cells/mm^3
Standard Deviation 561.10
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7 CD8⁺ (Absolute Count as cells/mm^3)
|
32.75 cells/mm^3
Standard Deviation 15.22
|
35.26 cells/mm^3
Standard Deviation 16.31
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day-0 to Day-14Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. This is the full analysis set of the study. From the NP-101 arms, flow cytometry assessment was not available for one patient, thus reducing the number of participants from 50 to 49.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. In this objective, we aim to compare the change in the ratio of CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. Both CD4+ and CD8+ are measured as absolute counts of cells per cubic milimeter.
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=60 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=49 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Difference of the Change From Randomization to Day-14 ın the Ratio of the Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
|
2.20 Ratio
Standard Deviation 1.11
|
2.10 Ratio
Standard Deviation 0.81
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day-0 to Day-14Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. This is the full analysis set of the study. From the NP-101 arms, flow cytometry assessment was not available for one patient, thus reducing the number of participants from 50 to 49.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. In this objective, we aim to compare the change in effector immune cells, specifically CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. We have a total of 36 markers for CD4+ and CD8+. Flow cytometry markers are combinations of the following immune cell types having various immune responses singly or in combination: CD3, CD5, CD8, CD16, CD19, CD45, CCR7, and CXCR3. The flow-cytomerty markers include the immune cell types: CD3, CD4, CD8, CD16, CD19, CD45, CCR7, and CXCR3. These Markers represent the percentages of the combination of these immune cell types or their percentages in the biological sample.
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=60 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=49 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CXCR3⁺ CD8⁺ (%)
|
2.40 Percentage
Standard Deviation 8.03
|
1.68 Percentage
Standard Deviation 9.12
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CCR7⁺ CD8⁺ (%)
|
-2.31 Percentage
Standard Deviation 10.78
|
-0.29 Percentage
Standard Deviation 9.76
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7 CD8⁺ (%)
|
1.53 Percentage
Standard Deviation 6.91
|
0.77 Percentage
Standard Deviation 8.06
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CXCR3⁺ CD4⁺ (%)
|
-0.07 Percentage
Standard Deviation 7.12
|
-0.38 Percentage
Standard Deviation 7.40
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CCR7⁺ CXCR3⁺ CD8⁺ (%)
|
0.15 Percentage
Standard Deviation 5.69
|
-0.43 Percentage
Standard Deviation 6.17
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7⁺ CD8⁺ (%)
|
-3.18 Percentage
Standard Deviation 8.86
|
-0.10 Percentage
Standard Deviation 10.67
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CCR7⁺ CXCR3⁺ CD4⁺ (%)
|
-0.23 Percentage
Standard Deviation 1.86
|
0.05 Percentage
Standard Deviation 2.13
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD8⁺ CD4⁺ (%)
|
0.00 Percentage
Standard Deviation 0.99
|
0.01 Percentage
Standard Deviation 0.52
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD16⁺ (%)
|
-1.34 Percentage
Standard Deviation 5.54
|
-0.86 Percentage
Standard Deviation 4.81
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD4⁺(%)
|
-0.08 Percentage
Standard Deviation 3.54
|
-0.42 Percentage
Standard Deviation 4.75
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7⁺ CD4⁺ (%)
|
1.31 Percentage
Standard Deviation 7.82
|
0.58 Percentage
Standard Deviation 7.87
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD8⁺ (%)
|
-0.46 Percentage
Standard Deviation 4.77
|
-0.35 Percentage
Standard Deviation 2.66
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CCR7 CD8⁺ (%)
|
1.71 Percentage
Standard Deviation 3.50
|
-0.07 Percentage
Standard Deviation 4.86
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ (%)
|
-0.60 Percentage
Standard Deviation 5.50
|
-0.50 Percentage
Standard Deviation 4.84
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CD3⁺ CD19⁺ (%)
|
1.57 Percentage
Standard Deviation 2.91
|
1.17 Percentage
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45⁺ CCR7⁺ CD4⁺ (%)
|
0.78 Percentage
Standard Deviation 7.53
|
-0.38 Percentage
Standard Deviation 6.34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
CD45 CCR7 CD4⁺ (%)
|
1.31 Percentage
Standard Deviation 7.82
|
0.58 Percentage
Standard Deviation 7.87
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day-0 to Day28Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. We compare the symptom progression rates between the two Phase-IIb arms. Both arms had sufficient symptom data to estimate the progression rates.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. In this objective, we aim to compare the rate of disease progression measured by the worsening by the Covid-19 symptoms from 'none' or 'mild' to 'moderate' or 'severe' and remaining at that level for at least two days before alleviation or resolution, or the experience of hospitalization or death due to Covid-19 symptom worsening in participants taking the MED of NP-101 versus placebo
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=60 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=50 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With Symptom Progression
|
24 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day-29 to Day-45Population: This analysis cohort includes only the participants of the two arms of Phase-IIb component of the trial. The long-covid symptom data was available for 49 NP-101 participants and 57 Placebo participants
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. In this objective, we aim to compare the rate of Long- Covid symptoms in participants taking the MED of NP-101 versus placebo. A patient will be classified as having experienced symptoms indicative of Long- Covid if they reported any new or ongoing mild, moderate, or severe Long- Covid symptoms captured on the daily symptom questionnaire, on any of the following days: Day 30 ± 2 days, Day 37 ± 2 days, or Day 45 ± 2 days
Outcome measures
| Measure |
Phase-IIb Placebo, Dose 6g
n=57 Participants
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb NP-101, Dose 6g
n=49 Participants
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIa NP-101, Dose 4.8
NP-101 Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 4.8g
Placebo Dose of 4.8g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa NP-101, Dose 6g
NP-101 Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIa Placebo, Dose 6g
Placebo Dose of 6g during the dose escalation Phase-IIa component of the trial
|
Phase-IIb NP-101, Dose 6g
NP-101 Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
Phase-IIb Placebo, Dose 6g
Placebo Phase-II Dose of 6g during the efficacy Phase-IIb component of the trial
|
|---|---|---|---|---|---|---|---|---|
|
Proportion of Paticipants With Long-Covid Symptoms
|
24 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase-IIa NP-101 Dose 3g
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase-IIa Placebo, Dose 3g
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase-IIa NP-101, Dose 4.8g
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase-IIa Placebo, Dose 4.8g
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase-IIa NP-101, Dose 6g
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase-IIa Placebo, Dose 6g
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase-IIb NP-101, Dose 6g
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase-IIb Placebo, Dose 6g
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase-IIa NP-101 Dose 3g
n=15 participants at risk
This arm includes participants treated with NP-101 Dose of 3g during the dose-escalation trial (Phase-IIa)
|
Phase-IIa Placebo, Dose 3g
n=5 participants at risk
This arm includes participants treated with Placebo Dose of 3g during the dose-escalation trial (Phase-IIa)
|
Phase-IIa NP-101, Dose 4.8g
n=15 participants at risk
This arm includes participants treated with NP-101 Dose of 4.8gg during the dose-escalation trial (Phase-IIa)
|
Phase-IIa Placebo, Dose 4.8g
n=5 participants at risk
This arm includes participants treated with Placebo Dose of 4.8g during the dose-escalation trial (Phase-IIa)
|
Phase-IIa NP-101, Dose 6g
n=15 participants at risk
This arm includes participants treated with NP-101 Dose of 6g during the dose-escalation trial (Phase-IIa)
|
Phase-IIa Placebo, Dose 6g
n=5 participants at risk
This arm includes participants treated with Placebo Dose of 6g during the dose-escalation trial (Phase-IIa)
|
Phase-IIb NP-101, Dose 6g
n=50 participants at risk
This arm includes participants treated with NP-101 at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
Phase-IIb Placebo, Dose 6g
n=60 participants at risk
This arm includes participants treated with Placebo at the Phase-II dose of 6g during the efficacy trial (Phase-IIb)
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Dry Eyes
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Nervous system disorders
Dysgeusia
|
13.3%
2/15 • Number of events 2 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
5.0%
3/60 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
|
Endocrine disorders
Polydipsia
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Eye disorders
Watery Eyes
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Blood and lymphatic system disorders
Wbc Decreased
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Eye disorders
Eye Itching
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.0%
3/50 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
8.3%
5/60 • Number of events 5 • From enrollment until the end of Day 45
Adverse Events
|
|
Eye disorders
Eye Swelling
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.0%
3/50 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
4/60 • Number of events 4 • From enrollment until the end of Day 45
Adverse Events
|
|
Eye disorders
Eye Discharge
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
2.0%
1/50 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
10.0%
6/60 • Number of events 6 • From enrollment until the end of Day 45
Adverse Events
|
|
Eye disorders
Eye Crusting
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
4.0%
2/50 • Number of events 2 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
4/60 • Number of events 4 • From enrollment until the end of Day 45
Adverse Events
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
8.3%
5/60 • Number of events 5 • From enrollment until the end of Day 45
Adverse Events
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
6.0%
3/50 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
8.3%
5/60 • Number of events 5 • From enrollment until the end of Day 45
Adverse Events
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
2.0%
1/50 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
4/60 • Number of events 4 • From enrollment until the end of Day 45
Adverse Events
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
40.0%
2/5 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 2 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
2.0%
1/50 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Hepatobiliary disorders
Alt Increased
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Psychiatric disorders
Anorexia
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Nervous system disorders
Anosmia
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
1.7%
1/60 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
|
Hepatobiliary disorders
Ast Increased
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
13.3%
2/15 • Number of events 2 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Metabolism and nutrition disorders
Bicarbonate Decreased Serum
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Renal and urinary disorders
Blood Bicarbonate Low
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Cardiac disorders
Chest pain
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
General disorders
Chills
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
5.0%
3/60 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Congestion Nasal
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
2.0%
1/50 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
5.0%
3/60 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
40.0%
2/5 • Number of events 2 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
3/15 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
13.3%
2/15 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
60.0%
3/5 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
16.0%
8/50 • Number of events 8 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
12/60 • Number of events 13 • From enrollment until the end of Day 45
Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
60.0%
3/5 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
13.3%
2/15 • Number of events 2 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
13.3%
2/15 • Number of events 2 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.0%
3/50 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
4/60 • Number of events 4 • From enrollment until the end of Day 45
Adverse Events
|
|
Renal and urinary disorders
Creatinine Blood Decreased
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Renal and urinary disorders
Creatinine Blood Increased
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.0%
3/50 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
5.0%
3/60 • Number of events 3 • From enrollment until the end of Day 45
Adverse Events
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
2.0%
1/50 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
3.3%
2/60 • Number of events 2 • From enrollment until the end of Day 45
Adverse Events
|
|
Gastrointestinal disorders
Increased Belching
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Investigations
Lactate Dehydrogenase Increased
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Runny Nose
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Metabolism and nutrition disorders
Sodium Blood Decreased
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/60 • From enrollment until the end of Day 45
Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
2.0%
1/50 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
3.3%
2/60 • Number of events 2 • From enrollment until the end of Day 45
Adverse Events
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/15 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/5 • From enrollment until the end of Day 45
Adverse Events
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
20.0%
1/5 • Number of events 1 • From enrollment until the end of Day 45
Adverse Events
|
0.00%
0/50 • From enrollment until the end of Day 45
Adverse Events
|
3.3%
2/60 • Number of events 2 • From enrollment until the end of Day 45
Adverse Events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place