NCT03459794

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Feb 2018

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 12, 2019

Completed
Last Updated

July 12, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

February 22, 2018

Results QC Date

January 10, 2019

Last Update Submit

April 26, 2019

Conditions

Ivermectin

Outcome Measures

Primary Outcomes (2)

  • The Number of Cytokines Showing Statistically Significant Changes From Pre-treatment Levels Will be Recorded.

    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 participants.

    Pre-treatment, 4 hours and 24 hours post-treatment

  • Number of Transcripts in PBMC With Statistically Significant Changes From Pre-treatment Levels.

    Changes in expression levels of approximately 770 genes involved in innate immunity will be measured in peripheral blood mononuclear cells (PBMC) before and after treatment. The number of transcripts with significant changes is taken from a comparison of the mean levels in each of the groups, not at the individual participant level. No pre-determined threshold was set for the biological significance of these changes.

    Pre-treatment, 4 hours and 24 hours post-treatment

Secondary Outcomes (1)

  • Complete Blood Counts (CBC)

    Pre-treatment (0hrs), 24 hours

Study Arms (2)

Ivermectin

ACTIVE COMPARATOR

Ivermectin will be administered once at 150mcg/kg, orally.

Drug: Ivermectin

Control

PLACEBO COMPARATOR

An oral placebo will be administered once

Other: Placebo

Interventions

IvermectinDRUG

150 mcg/kg ivermectin, by mouth.

Ivermectin
PlaceboOTHER

An oral placebo will be administered, once

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Weight over 110 pounds and under 185 pounds

You may not qualify if:

  • Pregnancy or nursing mothers.
  • Immunosuppressed individuals.
  • Hypersensitivity to ivermectin, cellulose, starch, magnesium stearate, butylated hydroxyanisole, or citric acid powder (inert ingredients of Stromectol).
  • Recent (last 3 years) travel to West or Central Africa, or any other country where onchocerciasis is present
  • Hepatitis/HIV
  • Currently taking warfarin
  • Lactose intolerance (Lactose present in placebo)
  • Currently taking Steroid medications (inhaled, oral or injection)
  • Currently taking Barbiturates, Benzodiazepines such as Xanax or Klonopin, Valproic acid (Lithium), Calcium channel blockers, Statins (cholesterol medication)
  • Liver or renal dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

Related Publications (1)

  • Wilson NE, Reaves BJ, Wolstenholme AJ. Lack of detectable short-term effects of a single dose of ivermectin on the human immune system. Parasit Vectors. 2021 Jun 5;14(1):304. doi: 10.1186/s13071-021-04810-6.

    PMID: 34090504DERIVED

MeSH Terms

Interventions

Ivermectin

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Results Point of Contact

Title
Dr Adrian Wolstenholme
Organization
University of Georgia
adrianw@uga.edu
706 542 2404

Study Officials

  • Adrian J Wolstenholme, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2018

First Posted

March 9, 2018

Study Start

February 12, 2018

Primary Completion

April 9, 2018

Study Completion

November 30, 2018

Last Updated

July 12, 2019

Results First Posted

July 12, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)