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NCT03459794 · ClinicalTrials.gov registry record · Early Phase 1
Ivermectin and Human Immunity
A Early Phase 1 study, sponsored by University of Georgia.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT03459794: Completed Early Phase 1 study, sponsored by University of Georgia.
NCT03459794 is a Early Phase 1 study that has completed, run by University of Georgia. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03459794, a Early Phase 1 study, has completed, sponsored by University of Georgia.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
We hypothesize that ivermectin, a drug used to treat parasitic worm infections, interacts with the human innate immune system and that this contributes to its anti-parasitic effects. Participants will donate blood before and after being administered the normal human dose of the drug. We will compare the cell types present in the blood and the chemicals known to influence the human immune system before and after the drug is given, as well as measuring any changes in gene expression in white blood cells 4 and 24hrs after the drug is taken.
Primary Outcome
Changes in serum levels of a panel of 41 cytokines will be compared to baseline levels using Luminex methods (HCYTOMAG-60K-PX41 kit from EMD Millipore). No pre-specified threshold was set for biological significance, and the number of cytokines showing a statistically significant (p=\<0.05) change from time 0 for each group will be reported. The number of cytokines with significant changes is taken from a comparison of the mean levels in each of the groups, not at the level of individual partici
Interventions
- OTHER Placebo
- DRUG Ivermectin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-02-12 |
| Est. Completion | 2018-11-30 |
| Phase | Early Phase 1 |
What the finished NCT03459794 record still lists
NCT03459794 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03459794 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03459794 about?
NCT03459794 is a clinical study titled "Ivermectin and Human Immunity". We hypothesize that ivermectin, a drug used to treat parasitic worm infections, interacts with the human innate immune system and that this contributes to its anti-parasitic effects. Participants will donate blood before and after being administered the normal human dose of the drug. We will compare...
What is the current status of trial NCT03459794?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2018-02-12. Estimated completion is 2018-11-30.
What interventions are being tested in trial NCT03459794?
The interventions under investigation include: Placebo (OTHER), Ivermectin (DRUG).
Who is sponsoring clinical trial NCT03459794?
This trial is sponsored by University of Georgia, which has 59 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03459794's enrollment target sits among peer trials
12 1529th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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