e. individuals with frequent common colds) to assess whether the study design could adequately assess the common cold using symptom scoring with the Jackson scale as well as by quality of life scoring with the 9-item Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Quality of Life (QoL) sub-score [ 14]. Repeated periods of infection are also linked to recurrent physical injuries that can be detrimental for the athlete and the team [6] . Conclusion The safety and tolerability of ColdZyme have been confirmed in a larger study population, while establishing evidence of a slightly faster recovery from common cold symptoms. Glycerol, water, a natural enzyme - cod trypsin, ethanol (<1%) (only in the menthol taste), calcium chloride, trometamol and menthol. Previous studies on the use of ColdZyme by elite athletes demonstrate that ColdZyme use reduced the number of sick days due to common cold, with a corresponding reduction in absence from training by >50% among the study participants [18] .

This was a double-blind, randomized, parallel-group, placebo-controlled study conducted at 10 German sites to evaluate the efficacy of the medical device ColdZyme, a glycerol mouth spray containing cold-adapted cod trypsin for a naturally occurring common cold versus placebo spray. Product photos are for illustrative purposes and may not reflect the actual product that you receive.

The medication contains proteins that can kill the virus before it can enter cells, reducing the chance of it causing any damage. The second major secondary endpoint was defined as the number of days with concomitant treatment possibly affecting common cold symptoms assessed during the first 4 days for each subject, based on the diary entries. Entries to diaries continued for 2 days after being symptom free (as determined by answering "No" to the question above for 2 days in a row), but no longer than 10 days in total. For calculation of mean, confidence intervals, frequencies and standard deviations, the statistical functions in Excel 2016 were used.

A positive difference between treatment groups was also seen for the subjects' assessments of global efficacy of the investigational product A robust safety profile for ColdZyme was demonstrated throughout the study. gov, number {"type":"clinical-trial","attrs":{"text":"NCT03794804","term_id":"NCT03794804"}}NCT03794804.

ColdZyme solution contains Glycerol, water, cod trypsin, ethanol (1%), calcium chloride, trometamol and menthol. A compliance of at least 80% of the correct quantity of the investigational product was seen for 265/436 (60. These findings confirm previous observations of shortened common cold duration when using ColdZyme [ 13, 14, 19].

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e. The reduction in Jackson symptom score was likewise significantly reduced with ColdZyme, although less discriminating than the 9-item WURSS-21 QoL domain.

Seventeen athletes, involved in competitive training on a professional or amateur level, were invited via e-mail to participate in a weekly electronic diary survey.

in 1958 [13] , where a separate incident has to be preceded with at least two days of a Jackson score < 5, could not be used. The first major secondary endpoint was defined as the AUC for the composite daily severity of all symptoms within the Jackson scale assessed during the first 8 days of common cold symptoms (AUC Jackson), based on the daily records (twice per day) for the Jackson scale items in the subjects’ common cold diary. The primary objective was to evaluate the impact on quality of life during a common cold episode based on the primary endpoint defined as the AUC of WURSS-21 QoL composite sub-score over 8 days following start of symptoms.A 1–2 day reduction in a common cold episode is consistent with other treatments of common colds [ 23, 24], but also how often subjects were asked to assess the presence of illness in this trial (once a day). uk accepts no liability for inaccuracies or misstatements about products by manufacturers or other third parties. However, those individuals that reported more than two sick days during the three months preceding the actual survey, seemed to benefit more from using ColdZyme [18] . Individual participant data, after having been anonymized, will be made available, along with the study protocol, statistical analysis plan and informed consent form template. The ColdZyme group showed broadly similar scores to the control group in the remaining secondary endpoints comprising the single items and symptoms of the WURSS-21 and Jackson scales, day with maximum score, use of and exposure during the first 4 days to concomitant treatment, duration of the first intense phase, symptom intensity, sore throat scale and number of days sick at home due to common cold.