Trial Outcomes & Findings for Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera (NCT NCT06193408)
NCT ID: NCT06193408
Last Updated: 2026-03-12
Results Overview
Means of stool output data expressed as ml/kg·h-1 for Treatment and Comparator groups.
COMPLETED
PHASE2
150 participants
Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours, e.g. hour 1, hour 6, hour 8, hour 10, hour 11, hour 22, hour 23, hour 26, etc.).
2026-03-12
Participant Flow
This study recruited 150 participants in total, meeting the inclusion criteria, of which 75 participants were double-blindly assigned to the Active Arm and 75 participants were assigned to the Placebo Arm.
Participants were randomized in a 1:1 ratio. VR-AD-1005 oral capsule was administered orally 4 times per day (approximately every 4-5 hours with overnight break to allow for participants rest and recovery) with first administration of 3 capsules as loading dose
Participant milestones
| Measure |
VR-AD-1005
Patients received VR-AD-1005 treatment for three days, or until recovery and discharge, in addition to the general cholera protocol treatment. After completing the 3-day treatment period all participants were followed up for 28 days.
|
Placebo
Patients received Placebo treatment for three days, or until recovery and discharge, in addition to the general cholera protocol treatment. After completing the 3-day treatment period all participants were followed up for 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
70
|
72
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Both genders were included into the study without selection bias. Any differences observed in the number of males and females in each group occurred randomly and were not a result of any selection bias.
Baseline characteristics by cohort
| Measure |
VR-AD-1005
n=70 Participants
Patients randomized to VR-AD-1005 treatment group (Active).
|
Placebo
n=72 Participants
Patients randomized to Placebo group (Placebo).
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=70 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=142 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=70 Participants
|
72 Participants
n=72 Participants
|
142 Participants
n=142 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=70 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=142 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=70 Participants • Both genders were included into the study without selection bias. Any differences observed in the number of males and females in each group occurred randomly and were not a result of any selection bias.
|
17 Participants
n=72 Participants • Both genders were included into the study without selection bias. Any differences observed in the number of males and females in each group occurred randomly and were not a result of any selection bias.
|
42 Participants
n=142 Participants • Both genders were included into the study without selection bias. Any differences observed in the number of males and females in each group occurred randomly and were not a result of any selection bias.
|
|
Sex: Female, Male
Male
|
45 Participants
n=70 Participants • Both genders were included into the study without selection bias. Any differences observed in the number of males and females in each group occurred randomly and were not a result of any selection bias.
|
55 Participants
n=72 Participants • Both genders were included into the study without selection bias. Any differences observed in the number of males and females in each group occurred randomly and were not a result of any selection bias.
|
100 Participants
n=142 Participants • Both genders were included into the study without selection bias. Any differences observed in the number of males and females in each group occurred randomly and were not a result of any selection bias.
|
|
Weight
|
52.35 kg
STANDARD_DEVIATION 8.21 • n=70 Participants
|
52.97 kg
STANDARD_DEVIATION 9.99 • n=72 Participants
|
52.66 kg
STANDARD_DEVIATION 9.13 • n=142 Participants
|
|
Acute watery diarrhea
|
15 hours
STANDARD_DEVIATION 13.9 • n=70 Participants
|
15.57 hours
STANDARD_DEVIATION 11.12 • n=72 Participants
|
15.29 hours
STANDARD_DEVIATION 12.53 • n=142 Participants
|
|
Episodes (diarrhea)
|
26.03 number of episodes
STANDARD_DEVIATION 14.55 • n=70 Participants
|
26.61 number of episodes
STANDARD_DEVIATION 11.71 • n=72 Participants
|
26.32 number of episodes
STANDARD_DEVIATION 13.14 • n=142 Participants
|
|
Vomiting
|
10.56 hours
STANDARD_DEVIATION 9.40 • n=70 Participants
|
10.16 hours
STANDARD_DEVIATION 7.88 • n=72 Participants
|
10.36 hours
STANDARD_DEVIATION 8.64 • n=142 Participants
|
|
Episodes (vomiting)
|
10.88 number of episodes
STANDARD_DEVIATION 7.77 • n=70 Participants
|
9.85 number of episodes
STANDARD_DEVIATION 6.82 • n=72 Participants
|
10.37 number of episodes
STANDARD_DEVIATION 7.30 • n=142 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours, e.g. hour 1, hour 6, hour 8, hour 10, hour 11, hour 22, hour 23, hour 26, etc.).Means of stool output data expressed as ml/kg·h-1 for Treatment and Comparator groups.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants randomized to Placebo treatment group (Placebo).
|
VR-AD-1005
n=75 Participants
Patients randomized to VR-AD-1005 treatment group (Active).
|
|---|---|---|
|
Stool Output Volume During Treatment Period.
Hour 10
|
5.88 ml/kg·h-1
Interval 4.86 to 6.91
|
4.56 ml/kg·h-1
Interval 3.9 to 5.2
|
|
Stool Output Volume During Treatment Period.
Hour 1
|
9.31 ml/kg·h-1
Interval 7.89 to 10.72
|
9.82 ml/kg·h-1
Interval 8.46 to 11.19
|
|
Stool Output Volume During Treatment Period.
Hour 6
|
7.29 ml/kg·h-1
Interval 6.24 to 8.35
|
5.69 ml/kg·h-1
Interval 4.81 to 6.56
|
|
Stool Output Volume During Treatment Period.
Hour 8
|
7.93 ml/kg·h-1
Interval 6.62 to 9.24
|
5.32 ml/kg·h-1
Interval 4.49 to 6.15
|
|
Stool Output Volume During Treatment Period.
Hour 11
|
5.19 ml/kg·h-1
Interval 4.29 to 6.09
|
3.72 ml/kg·h-1
Interval 3.03 to 4.41
|
|
Stool Output Volume During Treatment Period.
Hour 22
|
2.93 ml/kg·h-1
Interval 2.23 to 3.64
|
1.44 ml/kg·h-1
Interval 1.01 to 1.87
|
|
Stool Output Volume During Treatment Period.
Hour 23
|
2.12 ml/kg·h-1
Interval 1.58 to 2.66
|
1.30 ml/kg·h-1
Interval 0.9 to 1.7
|
|
Stool Output Volume During Treatment Period.
Hour 26
|
1.59 ml/kg·h-1
Interval 0.88 to 2.3
|
0.71 ml/kg·h-1
Interval 0.39 to 1.04
|
SECONDARY outcome
Timeframe: Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).For analysis, individual stool charts were used to calculate stool output per patient per hour and express it as stool volume in ml/hour. Duration of time during treatment when stool output was in excess of 200ml/hour was calculated for each participant and compared for control and study intervention groups.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants randomized to Placebo treatment group (Placebo).
|
VR-AD-1005
n=75 Participants
Patients randomized to VR-AD-1005 treatment group (Active).
|
|---|---|---|
|
Duration of Stool Output in Excess of 200 ml/Hour
|
15 Time until threshold, hours
Interval 9.0 to 15.0
|
10 Time until threshold, hours
Inter-Quartile Range 2287.5 • Interval 8.5 to 14.5
|
SECONDARY outcome
Timeframe: Unscheduled IV rehydration episodes were measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).Average number of unscheduled IV rehydration episodes per participant per study arm.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants randomized to Placebo treatment group (Placebo).
|
VR-AD-1005
n=75 Participants
Patients randomized to VR-AD-1005 treatment group (Active).
|
|---|---|---|
|
Number of Unscheduled IV Rehydration Episodes Per Treatment
|
1.11 episode
Interval 0.83 to 1.39
|
0.93 episode
Interval 0.71 to 1.16
|
SECONDARY outcome
Timeframe: Volume of administered IV rehydration solution was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).Average volume of IV rehydration per subject per treatment arm was calculated as aggregate per time period. Data were analyzed for three time periods, namely 0-12 hours; 0-24 hours; and the entire duration of treatment. For each period, mean volume of the infusion was calculated and expressed in ml/kg body weight.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants randomized to Placebo treatment group (Placebo).
|
VR-AD-1005
n=75 Participants
Patients randomized to VR-AD-1005 treatment group (Active).
|
|---|---|---|
|
Volume of IV Rehydration, ml/kg
Total over the entire treatment period
|
57 ml/kg
Interval 48.6 to 65.3
|
41.1 ml/kg
Interval 33.6 to 48.7
|
|
Volume of IV Rehydration, ml/kg
0-12 hours period
|
51 ml/kg
Interval 44.1 to 57.9
|
30.8 ml/kg
Interval 24.7 to 37.1
|
|
Volume of IV Rehydration, ml/kg
0-24 hours period
|
57 ml/kg
Interval 48.6 to 65.3
|
40.5 ml/kg
Interval 33.0 to 48.1
|
SECONDARY outcome
Timeframe: Liquid and solid stool output was measured by trained trial personnel and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).Diarrhea duration is measured from the first dose of study drug to resolution. Time (hours) from start of treatment until the last liquid stool was determined for each participant. Data were extracted from individual stool charts, and time-to-criterion was analyzed using log-rank statistics between the Treatment and the Comparator groups.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants randomized to Placebo treatment group (Placebo).
|
VR-AD-1005
n=75 Participants
Patients randomized to VR-AD-1005 treatment group (Active).
|
|---|---|---|
|
Time Until Last Liquid Stool
|
28 Time until threshold, hours
Interval 26.0 to 30.0
|
27 Time until threshold, hours
Interval 25.0 to 29.0
|
SECONDARY outcome
Timeframe: Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).For analysis, individual stool charts were used to calculate stool output per patient per hour and express it as stool volume in ml/hour. Duration of time during treatment when stool output was in excess of 400ml/hour was calculated for each participant and compared for control and study intervention groups.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants randomized to Placebo treatment group (Placebo).
|
VR-AD-1005
n=75 Participants
Patients randomized to VR-AD-1005 treatment group (Active).
|
|---|---|---|
|
Duration of Stool Output in Excess of 400 mL/Hour
|
8 Time until threshold, hours
Interval 3.0 to 8.5
|
5 Time until threshold, hours
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: From enrollment until the end of follow-up, up to 28 daysProportion of participants experiencing at least one adverse event (including serious adverse events) following administration of study treatment during the safety evaluation period.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants randomized to Placebo treatment group (Placebo).
|
VR-AD-1005
n=70 Participants
Patients randomized to VR-AD-1005 treatment group (Active).
|
|---|---|---|
|
Participants With at Least One Adverse Event
|
0 Participants
|
1 Participants
|
Adverse Events
VR-AD-1005
Placebo
Serious adverse events
| Measure |
VR-AD-1005
n=75 participants at risk
Patients received VR-AD-1005 treatment for three days, or until recovery and discharge, in addition to the general cholera protocol treatment. 3 days treatment period, 28 day follow up period.
|
Placebo
n=75 participants at risk
Patients received Placebo treatment for three days, or until recovery and discharge, in addition to the general cholera protocol treatment. 3 days treatment period, 28 day follow up period.
|
|---|---|---|
|
Vascular disorders
Death
|
1.3%
1/75 • From enrollment until the end of follow-up, up to 28 days
|
0.00%
0/75 • From enrollment until the end of follow-up, up to 28 days
|
Other adverse events
Adverse event data not reported
Additional Information
Dmitry Kravtsov MD, Chief Scientific Officer
Hunazine Biotech S.L.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place