COLDPREV II ENZY-002
Research type
Research Study
Full title
Evaluation of ColdZyme® on prevention and reduction of common cold symptoms on experimentally induced rhinovirus upper respiratory tract infection in healthy volunteers. -A double-blind, randomized, placebo-controlled study.
IRAS ID
182719
Contact name
Sebastian L Johnston
Contact email
Sponsor organisation
Enzymatica AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 2 days
Research summary
The clinical investigation is a single-site, double-blind, randomised, placebo-controlled trial. A previous clinical investigation (ENZY-001) showed that treatment with ColdZyme® reduces the in vivo virus load and shortens the duration of rhinovirus 16 induced common cold. 88 healthy volunteers will be included in the present clinical investigation. All 88 subjects will be inoculated with rhinovirus 16 via the nasal route. The subjects will be randomised 1:1 to ColdZyme® or placebo. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. The subjects will visit the investigational clinic on 6 occasions. During these visits the subjects will leave nasal (lavage) and pharyngeal (swab) samples for quantification of virus replication. All subjects will have a diary for scoring of cold symptoms. Additional consultations and contact (telephone calls or, if deemed necessary, visits) with the Principal Clinical Investigator will be provided as required.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
15/ES/0112
Date of REC Opinion
21 Aug 2015
REC opinion
Further Information Favourable Opinion