Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of rhLactoferrin on Chronic Inflammation in the Elderly (ELCIE)

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: NCT02968992
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Ventria Bioscience
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Inflammation
Cognitive Deterioration
Interventions Drug: rhLactoferrin
Other: Placebo
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title rhLactoferrin Placebo
Hide Arm/Group Description

rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.

rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.

Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Period Title: Overall Study
Started 18 18
Completed 18 17
Not Completed 0 1
Arm/Group Title rhLactoferrin Placebo Total
Hide Arm/Group Description

rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.

rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.

Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
18
 100.0%
18
 100.0%
36
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
82.6  (6.6) 79.6  (5.6) 81.1  (6.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
11
  61.1%
11
  61.1%
22
  61.1%
Male
7
  38.9%
7
  38.9%
14
  38.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
17
  94.4%
17
  94.4%
34
  94.4%
Unknown or Not Reported
1
   5.6%
1
   5.6%
2
   5.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.6%
0
   0.0%
1
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  16.7%
3
  16.7%
6
  16.7%
White
14
  77.8%
15
  83.3%
29
  80.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
BMI  
Measure Type: Count of Participants
Unit of measure:  Participants
BMI ≥ 30 Number Analyzed 18 participants 18 participants 36 participants
5
  27.8%
8
  44.4%
13
  36.1%
BMI < 30 Number Analyzed 18 participants 18 participants 36 participants
13
  72.2%
10
  55.6%
23
  63.9%
Physical mobility as measured by 4 meter walk test   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  M/sec
Number Analyzed 18 participants 17 participants 35 participants
0.78  (0.17) 0.78  (0.13) 0.78  (0.15)
[1]
Measure Description: A standard measurement of 4 meters is marked on a flat, long floor surface. The test taker is asked to walk the length at their usual pace while the test giver is recording the time with a stop watch. This test is repeated twice, and the average of the two recorded times is used as the data point.
[2]
Measure Analysis Population Description: A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis.
Physical strength as measured by grip strength   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 18 participants 17 participants 35 participants
26.2  (7.3) 25.3  (6.7) 25.8  (6.9)
[1]
Measure Description: Hand grip strength is measured by the amount of static force that the hand can squeeze around a dynamometer. An administrator recorded the reading on the device. The force was measured in kilograms.
[2]
Measure Analysis Population Description: A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis.
Physical mobility as measured by 6 minute walk test   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 17 participants 17 participants 34 participants
358.9  (124.3) 345.8  (88.9) 352.3  (106.6)
[1]
Measure Description: A measured course is set up in an open area on a hard flat surface. The test taker walks on this measured course for 6 minutes, and the test administrators calculates the distance traveled over 6 minutes. The test taker is allowed to rest as is needed.
[2]
Measure Analysis Population Description: A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis. One participant in the treatment group declined to complete the test.
Log Total Activity Count   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Log Total Activity Count
Number Analyzed 18 participants 17 participants 35 participants
14.26  (0.35) 14.46  (0.28) 14.35  (0.33)
[1]
Measure Description: Log total activity count was determined using the Acti-Graph® Link Activity monitor which generates a comprehensive assessment of daily free-living activity. Participants wore the monitor for 7 days. Activity counts are proprietary units generated by the Actigraph company software, Actilife. Counts are unitless quantities of physical activity compiled into one-minute intervals across three planes of movement. The vector magnitude of the sum of square of these counts generate the total activity per minute, per hour and per day.
[2]
Measure Analysis Population Description: A total of 36 participants entered the study, one participant in the placebo group later dropped out and therefore was not included in the analysis.
Attenuating cognitive decline as measured by the trail making test A and B   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Test A Number Analyzed 18 participants 17 participants 35 participants
48.3  (16.7) 54.1  (28.9) 51.1  (23.3)
Test B Number Analyzed 18 participants 16 participants 34 participants
101.1  (34.6) 109.3  (49.3) 104.9  (41.7)
[1]
Measure Description: For test A, the individual is given a sheet of paper that has the numbers 1-25 within individual circles randomly distributed. The individual is asked to connect the numbers sequentially. The score is recorded as the time it takes to complete the task in seconds. For test B, the individual is given a piece of paper that has numbers 1-13 and letters A-L. Each letter or number is inside of a circle. The test taker is instructed to draw a line from one number to the next letter (ie. 1 to A to 2 to B etc.). The score is the seconds it takes to complete the task.
[2]
Measure Analysis Population Description: A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis of test A and test B data. One additional participant in the placebo group was unable to complete Trail Making Test B, so they were not included in the analysis.
Attenuating cognitive decline as measured by the digital symbol substitution test   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Correct answers
Number Analyzed 18 participants 17 participants 35 participants
33  (12) 31  (10) 32  (11)
[1]
Measure Description: The test taker is given a key consisting of numbers 1-9 that are paired with a unique symbol. Below the key is a randomly generated list of the numbers repeated several times. The test taker is allowed 90 seconds to assign the correct symbol to the number on the list. The test administrator then scores the number of correct answers over the 90 second test time, and assigns a total score based on one point for each correct answer.
[2]
Measure Analysis Population Description: A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis.
1.Primary Outcome
Title The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6)
Hide Description The effect of rhlactoferrin on serum levels (picogram/milliliter) of Interleukin-6 (IL-6) will be assessed as a measure of the percentage change of IL-6 serum levels from baseline
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rhLactoferrin Placebo
Hide Arm/Group Description:

rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.

rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.

Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: Percent change of IL-6
-0.640  (1.137) 0.932  (0.265)
2.Primary Outcome
Title The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1)
Hide Description The effect of rhlactoferrin on serum levels (picogram/milliliter) of tumor necrosis factor alpha receptor 1 (TNFR1) assessed as a measure of the percentage change of serum TNFR1 levels from baseline
Time Frame From baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rhLactoferrin Placebo
Hide Arm/Group Description:

rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.

rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.

Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline
19.709  (85.084) 140.748  (43.24)
3.Secondary Outcome
Title Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test
Hide Description The test taker is given a key consisting of numbers 1-9 that are paired with a unique symbol. The test taker is allowed 90 seconds to assign the correct symbol to the number on the list. The test administrator then scores the number of correct answers over the 90 second test time, and assigns a total score based on one point for each correct answer and therefore a higher score is a better outcome.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rhLactoferrin Placebo
Hide Arm/Group Description:

rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.

rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.

Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Overall Number of Participants Analyzed 18 17
Mean (95% Confidence Interval)
Unit of Measure: correct responses
31.61
(26.07 to 37.16)
31
(25.42 to 36.58)
4.Secondary Outcome
Title Attenuating Cognitive Decline as Measured by the Trail Making Test A and B.
Hide Description For test A, the test taker is given a sheet of paper that has the numbers 1-25 within individual circles randomly distributed on the page. The test taker is asked to connect the numbers sequentially over a period of 4 minutes (240 seconds). The score is recorded as the time it takes to complete the task in seconds. For test B, the test taker is given a piece of paper that has numbers 1-13 and letters A-L. Each letter or number is inside of a circle. The test taker must then draw a line from one circled number to the next circled letter (ie. 1 to A to 2 to B to 3 to C etc.) over a period of 6 minutes (360 seconds). The time it takes to complete this task is recorded in seconds.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis. One additional participant in the placebo group was unable to complete Trail Making Test B, so they were not included in the analysis.
Arm/Group Title rhLactoferrin Placebo
Hide Arm/Group Description:

rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.

rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.

Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Overall Number of Participants Analyzed 18 17
Mean (95% Confidence Interval)
Unit of Measure: seconds
Trail Making Test A Number Analyzed 18 participants 17 participants
33.11
(26.36 to 39.85)
42.68
(35.89 to 49.47)
Trail Making Test B Number Analyzed 18 participants 16 participants
122.73
(92.31 to 153.14)
131.24
(100.61 to 161.87)
5.Secondary Outcome
Title Physical Mobility as Measured by 4 Meter Walk Test
Hide Description A standard measurement of 4 meters is marked on a flat, long floor surface. The test taker is asked to walk the length at their usual pace while the test giver is recording the time with a stop watch. This test is repeated twice, and the average of the two recorded times is used as the data point.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rhLactoferrin Placebo
Hide Arm/Group Description:

rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.

rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.

Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Overall Number of Participants Analyzed 18 17
Mean (95% Confidence Interval)
Unit of Measure: m/sec
0.786
(0.701 to 0.871)
0.767
(0.681 to 0.852)
6.Secondary Outcome
Title Physical Mobility as Measured by 6 Minute Walk Test
Hide Description A measured course is set up in an open area on a hard flat surface. The test taker walks on this measured course for 6 minutes, and the test administrators calculates the distance traveled over 6 minutes. The test taker is allowed to rest as is needed.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rhLactoferrin Placebo
Hide Arm/Group Description:

rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.

rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.

Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Overall Number of Participants Analyzed 18 17
Mean (95% Confidence Interval)
Unit of Measure: meter
359.66
(303.02 to 416.3)
334.94
(279.48 to 390.4)
7.Secondary Outcome
Title Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects
Hide Description Study coordinators administered side effect questionnaire at each visit and via phone every two weeks during the treatment period.
Time Frame From baseline through 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rhLactoferrin Placebo
Hide Arm/Group Description:

rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.

rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.

Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: Side effects/100 treatment days
2.23  (3.16) 4.77  (4.23)
8.Secondary Outcome
Title Physical Strength as Measured by Grip Strength
Hide Description Hand grip strength is measured by the amount of static force that the hand can squeeze around a dynamometer. An administrator recorded the reading on the device. The force was measured in kilograms.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rhLactoferrin Placebo
Hide Arm/Group Description:

rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.

rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.

Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Overall Number of Participants Analyzed 18 17
Mean (95% Confidence Interval)
Unit of Measure: kg
23.493
(20.694 to 26.337)
20.294
(17.34 to 23.157)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rhLactoferrin Placebo
Hide Arm/Group Description

rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.

rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.

Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.

All-Cause Mortality
rhLactoferrin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/18 (0.00%)    
Hide Serious Adverse Events
rhLactoferrin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      1/18 (5.56%)    
Infections and infestations     
Hospitalization  [1]  0/18 (0.00%)  0 1/18 (5.56%)  1
Indicates events were collected by systematic assessment
[1]
Participant suffered an infection from cat bite, which required hospitalization, and he was withdrawn from study
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
rhLactoferrin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/18 (72.22%)      15/18 (83.33%)    
Gastrointestinal disorders     
Diarrhea   2/18 (11.11%)  5/18 (27.78%) 
Constipation   3/18 (16.67%)  4/18 (22.22%) 
General disorders     
Loss of Appetite   2/18 (11.11%)  1/18 (5.56%) 
Fatigue   5/18 (27.78%)  4/18 (22.22%) 
Fever/chills  [1]  4/18 (22.22%)  0/18 (0.00%) 
Other conditions  [2]  12/18 (66.67%)  9/18 (50.00%) 
Skin and subcutaneous tissue disorders     
Skin rash   0/18 (0.00%)  1/18 (5.56%) 
Indicates events were collected by systematic assessment
[1]
Fever or chills were associated with respiratory infections
[2]
Other conditions consist of any other medical issues that were not included in the standard side effects.
The primary limitation of this study was the small sample size.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeremy D. Waltson, MD
Organization: Johns Hopkins University
Phone: 410-550-1003
EMail: jwalston@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02968992    
Other Study ID Numbers: IRB00094982
First Submitted: November 15, 2016
First Posted: November 21, 2016
Results First Submitted: January 30, 2020
Results First Posted: March 26, 2020
Last Update Posted: March 26, 2020