A Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Study on ColdZyme<sup>®</sup> Mouth Spray against Rhinovirus-Induced Common Cold

Abstract

Common colds incur significant costs in terms of sick leave and personal discomfort for affected individuals. This study investigated the performance of ColdZyme® Mouth Spray (ColdZyme), a protective barrier against common cold, in rhinovirus-inoculated healthy volunteers. This randomized, doubleblind, placebo-controlled pilot study was conducted on 46 healthy volunteers inoculated with rhinovirus 16 via the nose. Subjects self-administered ColdZyme or placebo 6 times daily for 11 days. Symptoms were recorded daily in a diary. Rhinovirus 16 in nasal and oropharyngeal samples at days 0, 3, 4, 6, 7 and 10 were quantified by RT-qPCR. The primary outcome measure was the reduction in viral load in oropharyngeal samples. Rhinovirus 16 was only detected in 35 out of 46 inoculated subjects. Exploratory analysis measuring the total viral load (i.e., area under the curve (AUC)) for days 3 -10 in successfully inoculated subjects found that ColdZyme treatment resulted in a lower total viral load in the oropharynx (p = 0.023). In subjects who experienced symptomatic common cold, irrespectively, if virus were detected, treatment with ColdZyme resulted in a reduction in the number of days with common cold symptoms from 6.5 to 3.0 days (p = 0.014) in comparison to placebo. ColdZyme reduced virus infection in the oropharynx and reduced the number of days with common cold symptoms and highlights the possible importance of the oropharynx in common cold infections. Suitable outcome measures for a feasible study on ColdZyme are total viral load in the oropharynx in subjects having detectable virus present in nasal or oropharyngeal samples.

User Experience of ColdZyme Mouth Spray against Common Cold in Competitive Athletes

“…These results support previous findings from a double-blind, placebo-controlled study, where subjects treated with ColdZyme displayed significantly decreased viral load and fewer days with common cold symptoms [10]. In the previously referred study [18] athletes who had less than 2 sick days during the preceding months did seem to be less prone to catch a cold during the study period.…”

“…To prevent infection, the natural barrier can be strengthened by depositing a barrier to the oropharyngeal mucous membrane. In a clinical study, ColdZyme decreased the viral load significantly (p = 0.02) and the number of days for one episode with common cold symptoms was reduced from 6.5 to 3 days, in comparison to placebo [10].…”

A medical device forming a protective barrier that deactivates four major common cold viruses

“…The performance of ColdZyme as a protective barrier against common cold virus has been confirmed in a clinical study on healthy volunteers inoculated with rhinovirus [8]. In the study, the total viral load in the oropharynx was significantly (by a factor of 10 8 ) lower and the number of days with manifested common cold symptoms was reduced from 6.5 days to 3 days in the group using ColdZyme compared to the placebo group.…”

“…nose and throat) with a treatment that at the same time has a high safety profile to match a mild disease such as the common cold. ColdZyme® Mouth Spray (ColdZyme) [8] is a medical device designed to possess these traits. The device is a viscous solution containing primarily glycerol and cod trypsin that is deposited on the mucous membrane of oropharynx.…”

Evaluation of ColdZyme Mouth Spray against Common Cold in Elderly Care Personnel

“…In order to prevent infection, the natural barrier can be strengthened by applying a glycerol-and enzymebased layer to the oropharyngeal mucosal membrane. This method was shown to be efficacious in a clinical study, in which the viral load significantly decreased (p = 0.02) and the number of days with common cold symptoms for one episode was reduced from 6.5 days to 3 days, in comparison to placebo [6].…”