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Trial record 2 of 106 for:    IVERMECTIN

Ivermectin and Human Immunity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03459794
Recruitment Status : Completed
First Posted : March 9, 2018
Results First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Adrian Wolstenholme, University of Georgia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Ivermectin
Interventions Drug: Ivermectin
Other: Placebo
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ivermectin Control
Hide Arm/Group Description

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

Ivermectin: 150 mcg/kg ivermectin, by mouth.

An oral placebo will be administered once

Placebo: An oral placebo will be administered, once

Period Title: Overall Study
Started 8 4
Completed 8 4
Not Completed 0 0
Arm/Group Title Ivermectin Control Total
Hide Arm/Group Description

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

Ivermectin: 150 mcg/kg ivermectin, by mouth.

An oral placebo will be administered once

Placebo: An oral placebo will be administered, once

Total of all reporting groups
Overall Number of Baseline Participants 8 4 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
4
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
Female
5
  62.5%
4
 100.0%
9
  75.0%
Male
3
  37.5%
0
   0.0%
3
  25.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
Hispanic or Latino
1
  12.5%
1
  25.0%
2
  16.7%
Not Hispanic or Latino
6
  75.0%
3
  75.0%
9
  75.0%
Unknown or Not Reported
1
  12.5%
0
   0.0%
1
   8.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
7
  87.5%
4
 100.0%
11
  91.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  12.5%
0
   0.0%
1
   8.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 4 participants 12 participants
8 4 12
1.Primary Outcome
Title The Number of Cytokines Showing Statistically Significant Changes From Pre-treatment Levels Will be Recorded.
Hide Description 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.
Time Frame Pre-treatment, 4 hours and 24 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Cytokines were measured in sera using the HCYTOMAG-60K-PX41 kit from EMD Millipore. The numbers reported are the number of cytokines with statistically significant changes ( p = <0.05) from pre-treatment levels.
Arm/Group Title Ivermectin 4hrs Ivermectin 24 Hrs Control 4 Hrs Control 24 Hrs
Hide Arm/Group Description:

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

Ivermectin: 150 mcg/kg ivermectin, by mouth. 4 hrs post-treatment

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

Ivermectin: 150 mcg/kg ivermectin, by mouth.24 hrs post-treatment

An oral placebo will be administered once

Placebo: An oral placebo will be administered, once. Sera collected 4hrs post-treatment

An oral placebo will be administered once

Placebo: An oral placebo will be administered, once. Sera collected 24hrs post-treatment

Overall Number of Participants Analyzed 8 8 4 4
Overall Number of Units Analyzed
Type of Units Analyzed: Cytokines
41 41 41 41
Measure Type: Number
Unit of Measure: Cytokines changed from t=0
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ivermectin 4hrs, Ivermectin 24 Hrs, Control 4 Hrs, Control 24 Hrs
Comments All measurements were compared to the same group at t=0, that is before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis We analyzed the changes is level for each cytokine between the groups. P value was adjusted for multiple comparisons and significance determined using the Holm-Sidak method. The threshold value for statistical significance for the mean value between groups was set at p =<0.05 for each cytokine measured. The number of cytokines that met this threshold is reported.
2.Primary Outcome
Title Number of Transcripts in PBMC With Statistically Significant Changes From Pre-treatment Levels.
Hide Description 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.
Time Frame Pre-treatment, 4 hours and 24 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Levels of 770 messenger RNAs (mRNAs) were assayed in PBMC isolated from study participants using the Human Nanostring Myeloid cell panel.
Arm/Group Title Ivermectin 4hrs Ivermectin 24 Hrs Control 4 Hrs Control 24 Hrs
Hide Arm/Group Description:

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

Ivermectin: 150 mcg/kg ivermectin, by mouth. 4 hrs post-treatment

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

Ivermectin: 150 mcg/kg ivermectin, by mouth.24 hrs post-treatment

An oral placebo will be administered once

Placebo: An oral placebo will be administered, once. Sera collected 4hrs post-treatment

An oral placebo will be administered once

Placebo: An oral placebo will be administered, once. Sera collected 24hrs post-treatment

Overall Number of Participants Analyzed 8 8 4 4
Measure Type: Number
Unit of Measure: Transcripts signicantly changed from t=0
0 0 10 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ivermectin 4hrs, Ivermectin 24 Hrs, Control 4 Hrs, Control 24 Hrs
Comments All measurements were compared to the same treated/control group at t=0, before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level. The p-value for each transcript is adjusted for multiple comparisons across all 770 transcripts, using the Benjamini-Yekutieli method. The number reported is the number of transcripts where p=<0.05.
3.Secondary Outcome
Title Complete Blood Counts (CBC)
Hide Description CBCs will be performed before treatment and 24 hrs later
Time Frame Pre-treatment (0hrs), 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ivermectin 0 Hrs Ivermectin 24 Hrs Control 0 Hrs Control 24 Hrs
Hide Arm/Group Description:

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

Ivermectin: 150 mcg/kg ivermectin, by mouth. Blood collected at t=0

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

Ivermectin: 150 mcg/kg ivermectin, by mouth.Blood collected 24 hrs post-treatment

An oral placebo will be administered once

Placebo: An oral placebo will be administered, once. Blood collected at t=0

An oral placebo will be administered once

Placebo: An oral placebo will be administered, once. Blood collected 24hrs post-treatment

Overall Number of Participants Analyzed 8 8 4 4
Mean (Standard Error)
Unit of Measure: Million cells/mL
Neutrophils 3.069  (0.353) 3.341  (0.426) 2.940  (0.18) 3.358  (0.47)
Lymphocytes 1.753  (0.22) 1.864  (0.151) 1.833  (0.161) 2.075  (0.175)
Monocytes 0.483  (0.045) 0.403  (0.057) 0.373  (0.04) 0.375  (0.034)
Eosinophils 0.208  (0.055) 0.205  (0.047) 0.158  (0.015) 0.170  (0.018)
Basophils 0.04  (0.008) 0.046  (0.006) 0.048  (0.008) 0.048  (0.0005)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ivermectin 0 Hrs, Ivermectin 24 Hrs, Control 0 Hrs, Control 24 Hrs
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Time Frame 1 day following administration of the drug/placebo
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ivermectin Control
Hide Arm/Group Description

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

Ivermectin: 150 mcg/kg ivermectin, by mouth.

An oral placebo will be administered once

Placebo: An oral placebo will be administered, once

All-Cause Mortality
Ivermectin Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
Ivermectin Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ivermectin Control
Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)   1/4 (25.00%) 
Gastrointestinal disorders     
Minor gastrointestinal upset *  1/8 (12.50%)  1/4 (25.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Adrian Wolstenholme
Organization: University of Georgia
Phone: 706 542 2404
EMail: adrianw@uga.edu
Layout table for additonal information
Responsible Party: Adrian Wolstenholme, University of Georgia
ClinicalTrials.gov Identifier: NCT03459794    
Other Study ID Numbers: STUDY00005069
First Submitted: February 22, 2018
First Posted: March 9, 2018
Results First Submitted: January 10, 2019
Results First Posted: July 12, 2019
Last Update Posted: July 12, 2019