Trial · NCT04188301
Safety and Efficacy of IDA for Onchocerciasis
NCT04188301, Phase 2, Completed, Washington University School of Medicine; results first posted 2023-05-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of IDA for Onchocerciasis. Trials, record NCT04188301. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04188301
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of IDA for Onchocerciasis
- NCT number
- NCT04188301
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 154 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Onchocerciasis
- Interventions
- IVM w/ ALB, Single dose of IDA, Three daily doses of IDA
- First posted
- 2019-12-05
- Last updated
- 2024-06-04
- Results first posted
- 2023-05-10
- Limitations and caveats
Pause on clinical trial operations between March 2020 - June 2020 due to the COVID-19 pandemic. Decreased health and viability of the adult female worm population in participants may have reduced the study's ability to detect a significant macrofilaricidal effect of IDA. Study enrolled participants with light/moderate infections, which greatly decreased the risk of SAEs occurring. Future studies to assess tolerability of IDA would need to be conducted with higher infection rates.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rates of Severe Adverse Events (SAEs) Across Study Arms | Within 7 days following end of treatment | Rates of severe adverse events (grade 3 or higher) following 1-day or 3-day triple drug treatment will be compared against those of the comparator regimen of 1 day of IVM/ALB. |
| Primary | Percentage of Worms Killed Across Study Arms | 18 months following treatment. | The effect of three treatment regimens for killing adult female O. volvulus worms will be compared based on the percentage of all adult female worms in nodules that are alive with embryos in the uterus 18 months after treatment. |
| Primary | Percentage of Worms Sterilized Across Study Arms | 18 months following treatment. | The effect of three treatment regimens for sterilizing adult female O. volvulus worms will be compared based on the percentage of all adult female worms that are fertile in the nodules 18 months after treatment. |
| Secondary | Rates of SAEs by Treatment Group in Those With Intraocular Microfilariae Just Prior to Treatment With IDA | within 7 days following end of treatment | Rates of adverse events grade 3 or higher that occur within 7 days of treatment in the subset of participants who have intraocular microfilariae just prior to treatment with IDA will be compared by treatment group. |
| Secondary | Rates of Ocular Adverse Events (Any Grade) by Treatment Group | within 3 months of treatment with IDA | Rates of ocular adverse events of any grade within 3 months will be compared by treatment group. |
| Secondary | Effectiveness of Killing Adult Female Worms | 18 months following treatment | The effectiveness of three treatment regimens for killing adult female O. volvulus worms based on the percentage of all adult female worms in nodules that are alive 18 months after treatment. |
| Secondary | Effectiveness of Clearing Microfilariae From Skin by Skin Snips | Baseline, 3 months, 12 months, & 18 months following treatment. | The effectiveness of three treatment regimens for complete clearance of microfilariae from the skin as determined by skin snips at 3, 12, and 18 months after treatment with IDA will be compared by treatment arm. |
| Secondary | Effectiveness for Preventing Reappearance of Microfilariae in the Skin by Skin Snips | Baseline, 12 months, and 18 months following treatment | The effectiveness of three treatment regimens for preventing reappearance of microfilariae in the skin as determined by skin snips at 12 and 18 months after treatment will be compared by treatment arm. Measured by the presence of microfilariae in skin snips. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rates of Severe Adverse Events (SAEs) Across Study Arms | Within 7 days following end of treatment | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Percentage of Worms Killed Across Study Arms | 18 months following treatment. | The analysis was conducted on worms from participants who had nodulectomies conducted at 18 months. Not all participants who completed the study had nodulectomies conducted. | Female worms in nodules | COUNT_OF_UNITS |
| SECONDARY | Rates of SAEs by Treatment Group in Those With Intraocular Microfilariae Just Prior to Treatment With IDA | within 7 days following end of treatment | For the Arm IDA x 3 doses, no participants had intraocular microfilariae present at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rates of Ocular Adverse Events (Any Grade) by Treatment Group | within 3 months of treatment with IDA | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Effectiveness of Killing Adult Female Worms | 18 months following treatment | Analysis conducted on participants who had nodulectomies conducted at 18 months. Not all participants who completed the study had nodulectomies conducted. | Female worms in nodule | COUNT_OF_UNITS |
| SECONDARY | Effectiveness of Clearing Microfilariae From Skin by Skin Snips | Baseline, 3 months, 12 months, & 18 months following treatment. | Count of Skin Microfilaria | GEOMETRIC_MEAN | |
| SECONDARY | Effectiveness for Preventing Reappearance of Microfilariae in the Skin by Skin Snips | Baseline, 12 months, and 18 months following treatment | Count of microfilarae+ participants | NUMBER | |
| PRIMARY | Percentage of Worms Sterilized Across Study Arms | 18 months following treatment. | The analysis was conducted on worms from participants who had nodulectomies conducted at 18 months. Not all participants who completed the study had nodulectomies conducted. Female worms were excluded who had collapsed uteri that could not be evaluated for fertility. | Female worms with intact uterus | COUNT_OF_UNITS |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rates of Severe Adverse Events (SAEs) Across Study Arms | IVM + ALB | 0 | Participants | ||
| Rates of Severe Adverse Events (SAEs) Across Study Arms | IDA x 1 Dose | 0 | Participants | ||
| Rates of Severe Adverse Events (SAEs) Across Study Arms | IDA x 3 Doses | 0 | Participants | ||
| Percentage of Worms Killed Across Study Arms | IVM + ALB | 127 | Female worms in nodules | ||
| Percentage of Worms Killed Across Study Arms | IDA x 1 Dose | 142 | Female worms in nodules | ||
| Percentage of Worms Killed Across Study Arms | IDA x 3 Doses | 159 | Female worms in nodules | ||
| Rates of SAEs by Treatment Group in Those With Intraocular Microfilariae Just Prior to Treatment With IDA | IVM + ALB | 0 | Participants | ||
| Rates of SAEs by Treatment Group in Those With Intraocular Microfilariae Just Prior to Treatment With IDA | IDA x 1 Dose | 0 | Participants | ||
| Rates of SAEs by Treatment Group in Those With Intraocular Microfilariae Just Prior to Treatment With IDA | IDA x 3 Doses | 0 | Participants | ||
| Rates of Ocular Adverse Events (Any Grade) by Treatment Group | IVM + ALB | 4 | Participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline | STARTED | IVM + ALB | 52 | |
| Baseline | STARTED | IDA x 1 Dose | 51 | |
| Baseline | STARTED | IDA x 3 Doses | 51 | |
| Baseline | COMPLETED | IVM + ALB | 52 | |
| Baseline | COMPLETED | IDA x 1 Dose | 51 | |
| Baseline | COMPLETED | IDA x 3 Doses | 51 | |
| Baseline | NOT COMPLETED | IVM + ALB | 0 | |
| Baseline | NOT COMPLETED | IDA x 1 Dose | 0 | |
| Baseline | NOT COMPLETED | IDA x 3 Doses | 0 | |
| Month 3 | STARTED | IVM + ALB | 52 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chills | General disorders | IVM + ALB | 1 | 52 | 1 |
| other | Chills | General disorders | IDA x 1 Dose | 3 | 51 | 3 |
| other | Chills | General disorders | IDA x 3 Doses | 1 | 51 | 1 |
| other | Diarrhea | Gastrointestinal disorders | IVM + ALB | 2 | 52 | 2 |
| other | Diarrhea | Gastrointestinal disorders | IDA x 1 Dose | 2 | 51 | 2 |
| other | Diarrhea | Gastrointestinal disorders | IDA x 3 Doses | 2 | 51 | 2 |
| other | Headache | Nervous system disorders | IVM + ALB | 1 | 52 | 1 |
| other | Headache | Nervous system disorders | IDA x 1 Dose | 4 | 51 | 4 |
| other | Headache | Nervous system disorders | IDA x 3 Doses | 0 | 51 | 0 |
| other | Itching skin | Skin and subcutaneous tissue disorders | IVM + ALB | 1 | 52 | 1 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IVM + ALB | 1 | 52 |
| Total, all-cause mortality | IDA x 1 Dose | 1 | 51 |
| Total, all-cause mortality | IDA x 3 Doses | 0 | 51 |
| Total, other adverse events | IVM + ALB | 11 | 52 |
| Total, other adverse events | IDA x 1 Dose | 15 | 51 |
| Total, other adverse events | IDA x 3 Doses | 11 | 51 |
| Total, serious adverse events | IVM + ALB | 0 | 52 |
| Total, serious adverse events | IDA x 1 Dose | 0 | 51 |
| Total, serious adverse events | IDA x 3 Doses | 0 | 51 |
Source ClinicalTrials.gov
Papers42
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04188301
GET https://conductscience.org/api/trials/v1/NCT04188301/results?page=2