Trial Outcomes & Findings for Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold (NCT NCT02522949)
NCT ID: NCT02522949
Last Updated: 2024-08-23
Results Overview
Reduction in viral load in the URT(Upper Respiratory Tract), after challenge with rhinovirus, in relation to placebo
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
7 days
Results posted on
2024-08-23
Participant Flow
Participant milestones
| Measure |
ColdZyme
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold
Baseline characteristics by cohort
| Measure |
ColdZyme
n=23 Participants
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=23 Participants
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
23 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
24.0 years
STANDARD_DEVIATION 5.7 • n=39 Participants
|
23.3 years
STANDARD_DEVIATION 3.3 • n=41 Participants
|
23.7 years
STANDARD_DEVIATION 4.6 • n=35 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
|
Region of Enrollment
Sweden
|
23 participants
n=39 Participants
|
23 participants
n=41 Participants
|
46 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 7 daysReduction in viral load in the URT(Upper Respiratory Tract), after challenge with rhinovirus, in relation to placebo
Outcome measures
| Measure |
ColdZyme
n=23 Participants
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=23 Participants
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Reduction in Viral Load in the URT
Nasal
|
4.9 log 10 copies/mL
Standard Error 0.6
|
4.1 log 10 copies/mL
Standard Error 0.6
|
|
Reduction in Viral Load in the URT
Oropharyngeal
|
3.6 log 10 copies/mL
Standard Error 0.6
|
3.3 log 10 copies/mL
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 11 daysReduction of number of days having a total symptom severity score of 6 or higher using a 5-graded Jackson scale, in relation to placebo. Will be assessed by the severity of cold symptoms quantified by the modified method of Jackson at peak day (day with highest score). A subject is considered to be a success if the total symptom score is below 6. Otherwise will the subject be classified as a failure to prevent symptomatic URTI.
Outcome measures
| Measure |
ColdZyme
n=23 Participants
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=23 Participants
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Prevention of Symptomatic URTI (Upper Respiratory Tract Infection)
No (Success if total symptom score is below 6 on peak day)
|
21 Participants
|
16 Participants
|
|
Prevention of Symptomatic URTI (Upper Respiratory Tract Infection)
Yes (Success if total symptom score is below 6 on peak day)
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 11 daysAsymptomatic URTI will be assessed by quantification of viral load at peak day (day with highest viral load measured by oropharyngeal swab). Will be assessed by quantification of viral load at peak day (day with highest viral load). A subject is considered to be a success if the viral load is not different from the base-line value (from day 0). Otherwise will the subject be classified as a failure to prevent asymptomatic URTI.
Outcome measures
| Measure |
ColdZyme
n=23 Participants
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=23 Participants
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Prevention of Asymptomatic URTI
No
|
18 Participants
|
15 Participants
|
|
Prevention of Asymptomatic URTI
Yes (success if viral load in oropharyngeal swab is 0 in peak day
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 11 daysThe number of days with cold is defined as the sum of all days with a total score of ≥ 6 according to the modified method of Jackson.
Outcome measures
| Measure |
ColdZyme
n=23 Participants
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=23 Participants
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Fewer Days With Symptomatic URTI
|
2.0 Days with symptomatic cold
Standard Deviation 2.3
|
3.0 Days with symptomatic cold
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 11 daysThe number of days with asymptomatic URTI is defined as the sum of all days with a viral load significantly different from the baseline.
Outcome measures
| Measure |
ColdZyme
n=23 Participants
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=23 Participants
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Fewer Days With Asymptomatic URTI
|
1.0 Days with asymptomatic cold
Standard Deviation 1.1
|
1.4 Days with asymptomatic cold
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 11 daysNasal samples will be analysed for the quantity of IL-6 (Interleukin 6), IL-8 and IFNα (Interferon alpha).
Outcome measures
| Measure |
ColdZyme
n=23 Participants
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=23 Participants
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Lower Level of Proinflammatory Proteins
IL-6
|
273.93 pg*day/mL
Standard Deviation 641.76
|
254.45 pg*day/mL
Standard Deviation 494.69
|
|
Lower Level of Proinflammatory Proteins
IL-8
|
1863.36 pg*day/mL
Standard Deviation 1597.92
|
2057.59 pg*day/mL
Standard Deviation 1792.90
|
|
Lower Level of Proinflammatory Proteins
IFNα
|
101.24 pg*day/mL
Standard Deviation 66.65
|
101.15 pg*day/mL
Standard Deviation 73.54
|
SECONDARY outcome
Timeframe: Day 0-10Jackson score was used and the \*mean\* sum of the score is reported. Jackson score is based on the sum of 5 severity points in the following scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 =very severe), where 0 is minimum and 4 is maximum score, for eight cold symptoms: sneezing, nasal obstruction, nasal discharge, sore throat, cough, headache, chilliness, and malaise.
Outcome measures
| Measure |
ColdZyme
n=23 Participants
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=23 Participants
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Lower Daily Total Symptom Score
Day 0
|
0.9 score on a 5 graded scale (0-4)
Standard Error 0.3
|
0.2 score on a 5 graded scale (0-4)
Standard Error 0.3
|
|
Lower Daily Total Symptom Score
Day 2
|
4.0 score on a 5 graded scale (0-4)
Standard Error 0.8
|
4.3 score on a 5 graded scale (0-4)
Standard Error 0.8
|
|
Lower Daily Total Symptom Score
Day 3
|
4.6 score on a 5 graded scale (0-4)
Standard Error 0.8
|
5.4 score on a 5 graded scale (0-4)
Standard Error 0.8
|
|
Lower Daily Total Symptom Score
Day 4
|
5.3 score on a 5 graded scale (0-4)
Standard Error 0.8
|
5.5 score on a 5 graded scale (0-4)
Standard Error 0.8
|
|
Lower Daily Total Symptom Score
Day 5
|
4.3 score on a 5 graded scale (0-4)
Standard Error 0.8
|
4.5 score on a 5 graded scale (0-4)
Standard Error 0.8
|
|
Lower Daily Total Symptom Score
Day 6
|
3.7 score on a 5 graded scale (0-4)
Standard Error 0.7
|
3.7 score on a 5 graded scale (0-4)
Standard Error 0.7
|
|
Lower Daily Total Symptom Score
Day 7
|
3.3 score on a 5 graded scale (0-4)
Standard Error 0.8
|
3.9 score on a 5 graded scale (0-4)
Standard Error 0.8
|
|
Lower Daily Total Symptom Score
Day 8
|
3.2 score on a 5 graded scale (0-4)
Standard Error 0.9
|
3.3 score on a 5 graded scale (0-4)
Standard Error 0.9
|
|
Lower Daily Total Symptom Score
Day 1
|
1.5 score on a 5 graded scale (0-4)
Standard Error 0.5
|
1.4 score on a 5 graded scale (0-4)
Standard Error 0.5
|
|
Lower Daily Total Symptom Score
Day 9
|
3.0 score on a 5 graded scale (0-4)
Standard Error 0.9
|
2.9 score on a 5 graded scale (0-4)
Standard Error 0.9
|
|
Lower Daily Total Symptom Score
Day 10
|
2.6 score on a 5 graded scale (0-4)
Standard Error 0.9
|
3.1 score on a 5 graded scale (0-4)
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Day 10Mean (average) value of the participants' score per symptom on day 10 is reported, i.e. per symptom, the total sum of participants self-reported Jackson score from 0 to 4, divided with number of participants on day 10. The Jackson scale for eight cold symptoms is used in the rating, using the following scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 =very severe , where 0 is no symptom and 4 is maximum symptoms (worsed), for eight cold symptoms: sneezing, nasal obstruction, nasal discharge, sore throat, cough, headache, chilliness, and malaise.
Outcome measures
| Measure |
ColdZyme
n=23 Participants
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=23 Participants
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Lower Daily Score of Individual Symptoms
Sneezing Day 10
|
0.22 score on a scale
Standard Deviation 0.52
|
0.17 score on a scale
Standard Deviation 0.65
|
|
Lower Daily Score of Individual Symptoms
Rhinorrhea Day 10
|
0.52 score on a scale
Standard Deviation 0.85
|
0.57 score on a scale
Standard Deviation 0.73
|
|
Lower Daily Score of Individual Symptoms
Nasal obstruction Day 10
|
0.39 score on a scale
Standard Deviation 0.72
|
0.52 score on a scale
Standard Deviation 0.85
|
|
Lower Daily Score of Individual Symptoms
Sore/scratchy throat Day 10
|
0.26 score on a scale
Standard Deviation 0.62
|
0.30 score on a scale
Standard Deviation 0.70
|
|
Lower Daily Score of Individual Symptoms
Cough Day 10
|
0.26 score on a scale
Standard Deviation 0.69
|
0.65 score on a scale
Standard Deviation 1.15
|
|
Lower Daily Score of Individual Symptoms
Headache Day 10
|
0.22 score on a scale
Standard Deviation 0.67
|
0.13 score on a scale
Standard Deviation 0.46
|
|
Lower Daily Score of Individual Symptoms
Malaise Day 10
|
0.48 score on a scale
Standard Deviation 0.85
|
0.43 score on a scale
Standard Deviation 0.73
|
|
Lower Daily Score of Individual Symptoms
Hoarseness Day 10
|
0.26 score on a scale
Standard Deviation 0.54
|
0.30 score on a scale
Standard Deviation 0.63
|
|
Lower Daily Score of Individual Symptoms
Chilliness Day 10
|
0.0 score on a scale
Standard Deviation 0.0
|
0.4 score on a scale
Standard Deviation 0.21
|
POST_HOC outcome
Timeframe: Day 3, 4, 5, 7, 10Population: Subjects with no viral load during the study excluded
Outcome measures
| Measure |
ColdZyme
n=19 Participants
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=16 Participants
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Area Under the Curve (AUC) for Day 3-10 in the Oropharyngeal Samples of Viral Load
|
6.6 copies*day/mL
Standard Deviation 7.41
|
11.30 copies*day/mL
Standard Deviation 6.17
|
POST_HOC outcome
Timeframe: 11 daysPopulation: Subjects with no viral load during the study excluded
Outcome measures
| Measure |
ColdZyme
n=19 Participants
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=16 Participants
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Number of Days With Asymptomatic Cold (Oropharyngeal Sample)
|
1.0 Days with asymptomatic cold
Standard Deviation 1.0
|
2.0 Days with asymptomatic cold
Standard Deviation 1.0
|
POST_HOC outcome
Timeframe: 11 daysPopulation: Subjects with no viral load during the study excluded
Outcome measures
| Measure |
ColdZyme
n=19 Participants
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=16 Participants
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Number of Days With Asymptomatic Cold (Nasal Sample)
|
3.0 Days with asymptomatic cold
Standard Deviation 1.5
|
4.0 Days with asymptomatic cold
Standard Deviation 1.5
|
POST_HOC outcome
Timeframe: 11 daysPopulation: Subjects with no symptomatic cold during the study excluded
Outcome measures
| Measure |
ColdZyme
n=21 Participants
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=16 Participants
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Number of Days With Symptomatic Cold
|
3.0 Days with symptomatic cold
Standard Deviation 2.1
|
6.5 Days with symptomatic cold
Standard Deviation 2.7
|
Adverse Events
ColdZyme
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ColdZyme
n=23 participants at risk
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
ColdZyme® mouth spray
|
Placebo
n=23 participants at risk
Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Placebo
|
|---|---|---|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Herpes simplex
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.7%
2/23 • Number of events 3
|
0.00%
0/23
|
|
General disorders
Pyrexia
|
0.00%
0/23
|
8.7%
2/23 • Number of events 3
|
|
Gastrointestinal disorders
Enlarged uvula
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place