COLDPREV – A randomized, double-blind, placebo-controlled inoculation study
Disease / Model:
Common cold. Inoculation, rhinovirus 16 infection.
Viral load for infected subjects and Number of days with symptomatic cold for subjects having symptoms > 5 on the Jackson scale.
Number of subjects:
46 healthy volunteers, 46 % female, mean age 24 (range: 20-49).
76 % (35 subjects)
6 times/day for 10 days
Duration of study:
University Hospital, Lund, Sweden
Reduction in viral load in the upper respiratory tract
Total oropharyngeal viral load for day 3-10
The viral load in the ColdZyme group is reduced with more than -99% compared with placebo (p =0,023)
Number of days with symptomatic cold
Days with max total score of Jackson scale > 5 among subjects who had a max total score of Jackson scale ≥ 6 sometime during the study
The number of sick-days in the ColdZyme group is reduced with more than half, -54%, compared with the placebo-group (p= 0.014), or from 6.5 sick-days to 3 sick-days.
- Nasal obstruction
- Sore/scratchy throat
The severity of each symptom is rated on a 5-grade scale as:
- 0: “absent”
- 1: “mild”
- 2: “moderate”
- 3: “severe”
- 4: “very severe”