COLDPREV – A randomized, double-blind, placebo-controlled inoculation study


Disease / Model:

Common cold. Inoculation, rhinovirus 16 infection.


End points:

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).


Infection rate:

76 %  (35 subjects)


Treatment:

6 times/day for 10 days


Duration of study:

21 days


Study center:

University Hospital, Lund, Sweden

Results


Primary endpoint:

Reduction in viral load in the upper respiratory tract


Outcome measure:

Total oropharyngeal viral load for day 3-10


Result:

The viral load in the ColdZyme group is reduced with more than -99% compared with placebo (p =0,023)




Secondary endpoint:

Number of days with symptomatic cold


Outcome measure:

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


Result:

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.


Symptom
  • Sneezing
  • Rhinorrhoea
  • Nasal obstruction
  • Sore/scratchy throat
  • Cough
  • Headache
  • Malaise
  • Hoarseness
  • Chilliness

The severity of each symptom is rated on a 5-grade scale as:
  • 0: “absent”
  • 1: “mild”
  • 2: “moderate”
  • 3: “severe”
  • 4: “very severe”