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Cholera still remains a global public health concern affecting both children and adults, and patients can succumb in quick time if remain untreated. Cholera is a secretory diarrhea and is generally treated with oral or intravenous rehydration therapy to compensate for the fluid loss. However, antimicrobial treatment is given to patients with moderate to severe diarrhea. The consistent emergence of multidrug-resistant bacteria is a major concern for the management of infectious diseases including cholera. No antisecretory drug has so far been proven successful. In a phase II clinical trial, the investigators will assess the effectiveness of a novel antisecretory drug VR-AD-1005 for treating cholera. Changes in stool volume and rehydration therapy will be assessed for VR-AD-1005 in comparison with placebo. If successful, this will be a huge advance in managing cholera and other secretory diarrhea. The introduction of the antisecretory drug can minimize the hospital stay and reduce antibiotic use, which in turn can reduce the emergence of antibiotic resistance among pathogens
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-AD-1005 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR-AD-1005 | Drug | oral capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Output Volume During Treatment Period. | Means of stool output data expressed as ml/kg·h-1 for Treatment and Comparator groups. | 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.). |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Stool Output in Excess of 200 ml/Hour | 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. | Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icddr,b | Dhaka | Bangladesh |
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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. Following randomization, 5 participants failed stool culture confirmation in the Active group and 3 participants failed in the Placebo group (screen failures), yielding 70 analyzable participants in the Active group and 72 in the placebo group.
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| ID | Title | Description |
|---|---|---|
| BG000 | VR-AD-1005 | Patients randomized to VR-AD-1005 treatment group (Active). |
| BG001 | Placebo | Patients randomized to Placebo group (Placebo). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age of the participant |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stool Output Volume During Treatment Period. | Means of stool output data expressed as ml/kg·h-1 for Treatment and Comparator groups. | Posted | Mean | 95% Confidence Interval | ml/kg·h-1 | 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.). |
|
From enrollment until the end of follow-up, up to 28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 3 days treatment period, 28 day follow up period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Vascular disorders | Systematic Assessment | The SAE was assessed as not related to receiving the invtervention. |
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The limitations included the variability in clinical course among patients, the reliance on a single high-resource center, the relatively small sample size. These constrained the ability to demonstrate statistical significance across all secondary endpoints. Moreover, oral dosing carries inherent limitations in patients with impaired consciousness or vomiting. IP dose was limited by safety concerns as first in-human study. Future studies should examine higher dosing options.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dmitry Kravtsov MD, Chief Scientific Officer | Hunazine Biotech S.L. | +12038368424 | dmitry.kravtsov@hunazinebiotech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2023 | May 6, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002771 | Cholera |
| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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randomized, placebo-controlled, double-blinded
| Drug |
oral capsule |
|
| Number of Unscheduled IV Rehydration Episodes Per Treatment | Average number of unscheduled IV rehydration episodes per participant per study arm. | Unscheduled IV rehydration episodes were measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours). |
| Volume of IV Rehydration, ml/kg | 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. | 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). |
| Time Until Last Liquid Stool | 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. | 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). |
| Duration of Stool Output in Excess of 400 mL/Hour | 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. | Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours). |
| Participants With at Least One Adverse Event | Proportion of participants experiencing at least one adverse event (including serious adverse events) following administration of study treatment during the safety evaluation period. | From enrollment until the end of follow-up, up to 28 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Adults, both genders | 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. | Count of Participants | Participants |
|
| Weight | Average weight of the participants | Mean | Standard Deviation | kg |
|
| Acute watery diarrhea | Duration of diarrhea prior to randomization. | Mean | Standard Deviation | hours |
|
| Episodes (diarrhea) | Number of diarrheal episodes prior to randomization. | Mean | Standard Deviation | number of episodes |
|
| Vomiting | Duration of vomiting prior to randomization | Mean | Standard Deviation | hours |
|
| Episodes (vomiting) | Number of vomiting episodes prior to randomization | Mean | Standard Deviation | number of episodes |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Duration of Stool Output in Excess of 200 ml/Hour | 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. | Posted | Median | Inter-Quartile Range | Time until threshold, hours | Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours). |
|
|
|
|
| Secondary | Number of Unscheduled IV Rehydration Episodes Per Treatment | Average number of unscheduled IV rehydration episodes per participant per study arm. | Posted | Mean | 95% Confidence Interval | episode | Unscheduled IV rehydration episodes were measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours). |
|
|
|
| Secondary | Volume of IV Rehydration, ml/kg | 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. | Posted | Mean | 95% Confidence Interval | ml/kg | 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). |
|
|
|
| Secondary | Time Until Last Liquid Stool | 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. | Posted | Median | 95% Confidence Interval | Time until threshold, hours | 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). |
|
|
|
|
| Secondary | Duration of Stool Output in Excess of 400 mL/Hour | 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. | Posted | Median | Inter-Quartile Range | Time until threshold, hours | Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours). |
|
|
|
|
| Secondary | Participants With at Least One Adverse Event | Proportion of participants experiencing at least one adverse event (including serious adverse events) following administration of study treatment during the safety evaluation period. | Posted | Count of Participants | Participants | From enrollment until the end of follow-up, up to 28 days |
|
|
|
| 1 |
| 75 |
| 1 |
| 75 |
| 0 |
| 75 |
| EG001 | Placebo | 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. | 0 | 75 | 0 | 75 | 0 | 75 |
|
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| D007239 | Infections |
| Total over the entire treatment period |
|