Trial Outcomes & Findings for Ivermectin and Human Immunity (NCT NCT03459794)
NCT ID: NCT03459794
Last Updated: 2019-07-12
Results Overview
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.
COMPLETED
EARLY_PHASE1
12 participants
Pre-treatment, 4 hours and 24 hours post-treatment
2019-07-12
Participant Flow
Participant milestones
| Measure |
Ivermectin
Ivermectin will be administered once at 150mcg/kg, orally.
Ivermectin: 150 mcg/kg ivermectin, by mouth.
|
Control
An oral placebo will be administered once
Placebo: An oral placebo will be administered, once
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
|
Overall Study
COMPLETED
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ivermectin and Human Immunity
Baseline characteristics by cohort
| Measure |
Ivermectin
n=8 Participants
Ivermectin will be administered once at 150mcg/kg, orally.
Ivermectin: 150 mcg/kg ivermectin, by mouth.
|
Control
n=4 Participants
An oral placebo will be administered once
Placebo: An oral placebo will be administered, once
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=39 Participants
|
4 participants
n=41 Participants
|
12 participants
n=35 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment, 4 hours and 24 hours post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Ivermectin 4hrs
n=41 Cytokines
Ivermectin will be administered once at 150mcg/kg, orally.
Ivermectin: 150 mcg/kg ivermectin, by mouth. 4 hrs post-treatment
|
Ivermectin 24 Hrs
n=41 Cytokines
Ivermectin will be administered once at 150mcg/kg, orally.
Ivermectin: 150 mcg/kg ivermectin, by mouth.24 hrs post-treatment
|
Control 4 Hrs
n=41 Cytokines
An oral placebo will be administered once
Placebo: An oral placebo will be administered, once. Sera collected 4hrs post-treatment
|
Control 24 Hrs
n=41 Cytokines
An oral placebo will be administered once
Placebo: An oral placebo will be administered, once. Sera collected 24hrs post-treatment
|
|---|---|---|---|---|
|
The Number of Cytokines Showing Statistically Significant Changes From Pre-treatment Levels Will be Recorded.
|
0 Cytokines changed from t=0
|
0 Cytokines changed from t=0
|
0 Cytokines changed from t=0
|
0 Cytokines changed from t=0
|
PRIMARY outcome
Timeframe: Pre-treatment, 4 hours and 24 hours post-treatmentPopulation: Levels of 770 messenger RNAs (mRNAs) were assayed in PBMC isolated from study participants using the Human Nanostring Myeloid cell panel.
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.
Outcome measures
| Measure |
Ivermectin 4hrs
n=8 Participants
Ivermectin will be administered once at 150mcg/kg, orally.
Ivermectin: 150 mcg/kg ivermectin, by mouth. 4 hrs post-treatment
|
Ivermectin 24 Hrs
n=8 Participants
Ivermectin will be administered once at 150mcg/kg, orally.
Ivermectin: 150 mcg/kg ivermectin, by mouth.24 hrs post-treatment
|
Control 4 Hrs
n=4 Participants
An oral placebo will be administered once
Placebo: An oral placebo will be administered, once. Sera collected 4hrs post-treatment
|
Control 24 Hrs
n=4 Participants
An oral placebo will be administered once
Placebo: An oral placebo will be administered, once. Sera collected 24hrs post-treatment
|
|---|---|---|---|---|
|
Number of Transcripts in PBMC With Statistically Significant Changes From Pre-treatment Levels.
|
0 Transcripts signicantly changed from t=0
|
0 Transcripts signicantly changed from t=0
|
10 Transcripts signicantly changed from t=0
|
0 Transcripts signicantly changed from t=0
|
SECONDARY outcome
Timeframe: Pre-treatment (0hrs), 24 hoursCBCs will be performed before treatment and 24 hrs later
Outcome measures
| Measure |
Ivermectin 4hrs
n=8 Participants
Ivermectin will be administered once at 150mcg/kg, orally.
Ivermectin: 150 mcg/kg ivermectin, by mouth. 4 hrs post-treatment
|
Ivermectin 24 Hrs
n=8 Participants
Ivermectin will be administered once at 150mcg/kg, orally.
Ivermectin: 150 mcg/kg ivermectin, by mouth.24 hrs post-treatment
|
Control 4 Hrs
n=4 Participants
An oral placebo will be administered once
Placebo: An oral placebo will be administered, once. Sera collected 4hrs post-treatment
|
Control 24 Hrs
n=4 Participants
An oral placebo will be administered once
Placebo: An oral placebo will be administered, once. Sera collected 24hrs post-treatment
|
|---|---|---|---|---|
|
Complete Blood Counts (CBC)
Neutrophils
|
3.069 Million cells/mL
Standard Error 0.353
|
3.341 Million cells/mL
Standard Error 0.426
|
2.940 Million cells/mL
Standard Error 0.18
|
3.358 Million cells/mL
Standard Error 0.47
|
|
Complete Blood Counts (CBC)
Lymphocytes
|
1.753 Million cells/mL
Standard Error 0.22
|
1.864 Million cells/mL
Standard Error 0.151
|
1.833 Million cells/mL
Standard Error 0.161
|
2.075 Million cells/mL
Standard Error 0.175
|
|
Complete Blood Counts (CBC)
Monocytes
|
0.483 Million cells/mL
Standard Error 0.045
|
0.403 Million cells/mL
Standard Error 0.057
|
0.373 Million cells/mL
Standard Error 0.04
|
0.375 Million cells/mL
Standard Error 0.034
|
|
Complete Blood Counts (CBC)
Eosinophils
|
0.208 Million cells/mL
Standard Error 0.055
|
0.205 Million cells/mL
Standard Error 0.047
|
0.158 Million cells/mL
Standard Error 0.015
|
0.170 Million cells/mL
Standard Error 0.018
|
|
Complete Blood Counts (CBC)
Basophils
|
0.04 Million cells/mL
Standard Error 0.008
|
0.046 Million cells/mL
Standard Error 0.006
|
0.048 Million cells/mL
Standard Error 0.008
|
0.048 Million cells/mL
Standard Error 0.0005
|
Adverse Events
Ivermectin
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ivermectin
n=8 participants at risk
Ivermectin will be administered once at 150mcg/kg, orally.
Ivermectin: 150 mcg/kg ivermectin, by mouth.
|
Control
n=4 participants at risk
An oral placebo will be administered once
Placebo: An oral placebo will be administered, once
|
|---|---|---|
|
Gastrointestinal disorders
Minor gastrointestinal upset
|
12.5%
1/8 • 1 day following administration of the drug/placebo
|
25.0%
1/4 • 1 day following administration of the drug/placebo
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place