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A Study to Examine the Duration of Effect of PrEP-001 in Healthy Subjects Challenged With HRV-16

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ClinicalTrials.gov Identifier: NCT03338556
Recruitment Status : Completed
First Posted : November 9, 2017
Results First Posted : June 27, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
Hvivo
Information provided by (Responsible Party):
Prep Biopharm Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Viral Upper Respiratory Tract Infection
Interventions Drug: PrEP-001
Other: Placebo
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort A - PrEP-001 Cohort A - Placebo Cohort B- PrEP-001 Cohort B - Placebo
Hide Arm/Group Description

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

PrEP-001

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

Placebo

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

PrEP-001

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

Placebo

Period Title: Overall Study
Started 25 27 24 26
Completed 23 23 22 24
Not Completed 2 4 2 2
Arm/Group Title Cohort A - PrEP-001 Cohort A - Placebo Cohort B- PrEP-001 Cohort B - Placebo Total
Hide Arm/Group Description

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

PrEP-001

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

Placebo

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

PrEP-001

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 25 27 24 26 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 24 participants 26 participants 102 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
27
 100.0%
24
 100.0%
26
 100.0%
102
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 24 participants 26 participants 102 participants
24.3  (6.26) 24.9  (8.30) 21.7  (2.93) 22.2  (3.58) 23.3  (5.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 24 participants 26 participants 102 participants
Female
12
  48.0%
11
  40.7%
4
  16.7%
9
  34.6%
36
  35.3%
Male
13
  52.0%
16
  59.3%
20
  83.3%
17
  65.4%
66
  64.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 25 participants 27 participants 24 participants 26 participants 102 participants
25 27 24 26 102
1.Primary Outcome
Title Total Symptom Scores
Hide Description

Overall total symptom score (TSS), defined as the sum of the total symptom scores from day 1 to day 8 inclusive, using the 10-point symptom diary card on a 0 - 3 point scale

The following symptoms in the 10-item symptoms questionnaire were graded on a scale of 0-3, where Grade 0 was absence, Grade 1 was just noticeable, Grade 2 was bothersome but did not prevent participation in activities, and Grade 3 was bothersome and interfered with activities:

Runny nose, Stuffy nose, Sneezing, Sore throat, Earache, Tiredness, Cough, Shortness of breath, Headache, Muscle/joint ache.

Diary cards were filled out 3 times/day on Day 1-7 and once on Day 8. Possible range of outcomes for TSS: 0 - 660 (higher numbers indicating worse outcomes)

Time Frame 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Note :Cohort B PrEP-001 active group had n=21 (one less than completed the study n=22)
Arm/Group Title Cohort A - PrEP-001 Cohort A - Placebo Cohort B- PrEP-001 Cohort B - Placebo
Hide Arm/Group Description:

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

PrEP-001

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

Placebo

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

PrEP-001

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

Placebo

Overall Number of Participants Analyzed 23 23 21 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
22.5  (21.63) 34.2  (38.67) 36.2  (38.19) 33.5  (40.54)
2.Secondary Outcome
Title Area Under Curve of Symptom Scores
Hide Description

Total symptom scores (from the 10-item modified Jackson symptom diary card) were used to calculate the AUC, from Day 1 (Assessment 1) to Day 8, after challenge, for each subject using the trapezium rule, based on the available non-missing calculated total symptom scores between Day 1 (Assessment 1) and Day 8. The 10-point symptom diary card, measured three times daily was combined to generate total symptom score. The following symptoms in the 10-item symptoms questionnaire were graded on a scale of 0-3, where Grade 0 was absence, Grade 1 was just noticeable, Grade 2 was bothersome but did not prevent participation in activities, and Grade 3 was bothersome and interfered with activities:

Runny nose, Stuffy nose, Sneezing, Sore throat, Earache, Tiredness, Cough, Shortness of breath, Headache, Muscle/joint ache

Time Frame 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Note :Cohort B PrEP-001 active group had n=21 (one less than completed the study n=22)
Arm/Group Title Cohort A - PrEP-001 Cohort A - Placebo Cohort B- PrEP-001 Cohort B - Placebo
Hide Arm/Group Description:

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

PrEP-001

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

Placebo

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

PrEP-001

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

Placebo

Overall Number of Participants Analyzed 23 23 20 23
Mean (Standard Deviation)
Unit of Measure: scores*minutes
10668.8  (10359.03) 16543.3  (18742.21) 17782.2  (18533.03) 16385.7  (19936.53)
3.Secondary Outcome
Title Incidence(s) of Laboratory Confirmed Illness
Hide Description The number of subjects with laboratory confirmed HRV-16 infection (as defined by a positive quantitative polymerase chain reaction (qPCR) result from the combined nasal washes of days 3, 4 and 5) who displayed clinical symptoms of upper respiratory tract (using the 10-item diary card, Day 1 to Day 8) – ITT analysis set
Time Frame 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Note :Cohort B PrEP-001 active group had n=21 (one less than completed the study n=22)
Arm/Group Title Cohort A - PrEP-001 Cohort A - Placebo Cohort B- PrEP-001 Cohort B - Placebo
Hide Arm/Group Description:

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

PrEP-001

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

Placebo

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

PrEP-001

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

Placebo

Overall Number of Participants Analyzed 23 23 21 24
Measure Type: Number
Unit of Measure: participants
10 13 13 12
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort A - PrEP-001 Cohort A - Placebo Cohort B- PrEP-001 Cohort B - Placebo
Hide Arm/Group Description

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

PrEP-001

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

Placebo

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

PrEP-001

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

Placebo

All-Cause Mortality
Cohort A - PrEP-001 Cohort A - Placebo Cohort B- PrEP-001 Cohort B - Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort A - PrEP-001 Cohort A - Placebo Cohort B- PrEP-001 Cohort B - Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/27 (0.00%)   0/24 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Cohort A - PrEP-001 Cohort A - Placebo Cohort B- PrEP-001 Cohort B - Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/25 (76.00%)   16/27 (59.26%)   18/24 (75.00%)   11/26 (42.31%) 
Injury, poisoning and procedural complications         
Procedural haemorrhage  1  12/25 (48.00%)  9/27 (33.33%)  8/24 (33.33%)  6/26 (23.08%) 
Sunburn  1  0/25 (0.00%)  1/27 (3.70%)  1/24 (4.17%)  0/26 (0.00%) 
Investigations         
C-reactive protein increased  1  0/25 (0.00%)  2/27 (7.41%)  2/24 (8.33%)  4/26 (15.38%) 
Blood fibrinogen increased  1  3/25 (12.00%)  2/27 (7.41%)  0/24 (0.00%)  0/26 (0.00%) 
Alanine aminotransferase increased  1  0/25 (0.00%)  0/27 (0.00%)  3/24 (12.50%)  1/26 (3.85%) 
Aspartate aminotransferase increased  1  0/25 (0.00%)  1/27 (3.70%)  2/24 (8.33%)  0/26 (0.00%) 
Blood bilirubin increased  1  1/25 (4.00%)  0/27 (0.00%)  1/24 (4.17%)  1/26 (3.85%) 
Lymphocyte count decreased  1  0/25 (0.00%)  2/27 (7.41%)  0/24 (0.00%)  0/26 (0.00%) 
Neutrophil count decreased  1  1/25 (4.00%)  0/27 (0.00%)  1/24 (4.17%)  0/26 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Epistaxis  1  3/25 (12.00%)  0/27 (0.00%)  0/24 (0.00%)  0/26 (0.00%) 
Blood and lymphatic system disorders  1  0/25 (0.00%)  1/27 (3.70%)  2/24 (8.33%)  1/26 (3.85%) 
Neutropenia  1  0/25 (0.00%)  0/27 (0.00%)  1/24 (4.17%)  1/26 (3.85%) 
Nervous system disorders  1  0/25 (0.00%)  0/27 (0.00%)  2/24 (8.33%)  0/26 (0.00%) 
Headache  1  0/25 (0.00%)  0/27 (0.00%)  2/24 (8.33%)  0/26 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Chief Medical Officer
Organization: PrEP Biopharm Limited
Phone: 8666207176 ext 0
Responsible Party: Prep Biopharm Limited
ClinicalTrials.gov Identifier: NCT03338556     History of Changes
Other Study ID Numbers: PrEP-CS-003
First Submitted: October 20, 2017
First Posted: November 9, 2017
Results First Submitted: April 17, 2018
Results First Posted: June 27, 2018
Last Update Posted: November 9, 2018