Coldzyme® Mouth Spray reduces duration of upper respiratory tract infection symptoms in endurance athletes under free living conditions

Davison, Glen; Perkins, Eleanor; Jones, Arwel W.; Swart, Gabriella M.; Jenkins, Alex R; Robinson, Hayley; Dargan, Kimberly

doi:10.1080/17461391.2020.1771429

Cited by 16 publications

(24 citation statements)

References 38 publications

(73 reference statements)

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“…In a smaller open-label study in athletes, the proportions of virus-protected persons per treatment group were not released, but there was no significant difference in number of CC episodes/person between the CZ-MD and control group [ 53 ]. The study mixing (unweighted) data obtained from winter seasons over 2 years claimed a reduction of 3.5 days with CZ-MD versus the controls.…”

Section: Resultsmentioning

confidence: 99%

“…Isolated adverse effects reported in the studies included labial Herpes simplex infection and urticaria, not related to the MD [ 54 ] and unsettled stomach, potentially related [ 53 ]. In the prospective trial NCT03831763 reporting on 267 of the 400 targeted participants, the manufacturer’s press release discloses: “no side effects attributable to ColdZyme were reported”.…”

Section: Resultsmentioning

confidence: 99%

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Does Trypsin Oral Spray (Viruprotect®/ColdZyme®) Protect against COVID-19 and Common Colds or Induce Mutation? Caveats in Medical Device Regulations in the European Union

Huijghebaert¹,

Vanham

Winckel

et al. 2021

IJERPH

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Background: nasal or oral sprays are often marketed as medical devices (MDs) in the European Union to prevent common cold (CC), with ColdZyme®/Viruprotect® (trypsin/glycerol) mouth spray claiming to prevent colds and the COVID-19 virus from infecting host cells and to shorten/reduce CC symptoms as an example. We analyzed the published (pre)-clinical evidence. Methods: preclinical: comparison of in vitro tests with validated host cell models to determine viral infectivity. Clinical: efficacy, proportion of users protected against virus (compared with non-users) and safety associated with trypsin/glycerol. Results: preclinical data showed that exogenous trypsin enhances SARSCoV2 infectivity and syncytia formation in host models, while culture passages in trypsin presence induce spike protein mutants. The manufacturer claims >98% SARSCoV2 deactivation, although clinically irrelevant as based on a tryptic viral digest, inserting trypsin inactivation before host cells exposure. Efficacy and safety were not adequately addressed in clinical studies or leaflets (no COVID-19 data). Protection was obtained among 9–39% of users, comparable to or lower than placebo-treated or non-users. Several potential safety risks (tissue digestion, bronchoconstriction) were identified. Conclusions: the current European MD regulations may result in insufficient exploration of (pre)clinical proof of action. Exogenous trypsin exposure even raises concerns (higher SARS-CoV-2 infectivity, mutations), whereas its clinical protective performance against respiratory viruses as published remains poor and substandard.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Does Trypsin Oral Spray (Viruprotect®/ColdZyme®) Protect against COVID-19 and Common Colds or Induce Mutation? Caveats in Medical Device Regulations in the European Union

Huijghebaert¹,

Vanham

Winckel

et al. 2021

IJERPH

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“…Coronaviruses cause about one‐third of the common cold cases 4 . The efficacy and safety of CZ‐MD against the common cold have been demonstrated in clinical trials 9,10 . Furthermore, active SARS‐CoV‐2 replication in the upper respiratory tract was demonstrated in patients suffering from COVID‐19 with high virus shedding 2 .…”

Section: Discussionmentioning

confidence: 99%

“…The CZ‐MD is believed to act on the viral surface proteins that would perturb their entry pathway into cells 8 . Clinical trials demonstrate the safety and efficacy of CZ‐MD against the common cold 9,10 . Also, in vitro studies have shown inactivation of respiratory viruses such as rhinovirus (HRV), respiratory syncytial virus (RSV), and influenza by the CZ‐MD 8 …”

Section: Introductionmentioning

confidence: 99%

“…8 Clinical trials demonstrate the safety and efficacy of CZ-MD against the common cold. 9,10 Also, in vitro studies have shown inactivation of respiratory viruses such as rhinovirus (HRV), respiratory syncytial virus (RSV), and influenza by the CZ-MD. 8 The entry of coronaviruses into host cells is mediated by the spike (S) glycoprotein that forms homotrimers protruding from the virus surface.…”

mentioning

confidence: 99%

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Inactivation of SARS‐CoV‐2 and HCoV‐229E in vitro by ColdZyme® a medical device mouth spray against the common cold

Guðmundsdóttir

Scheving

Lindberg

et al. 2020

Journal of Medical Virology

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Background The COVID‐19 pandemic calls for effective and safe treatments. SARS‐CoV‐2 causing COVID‐19 actively replicates in the throat, unlike SARS‐CoV, and shows high pharyngeal viral shedding even in patients with mild symptoms of the disease. HCoV‐229E is one of four coronaviruses causing the common cold. In this study, the efficacy of ColdZyme® (CZ‐MD), a medical device mouth spray, was tested against SARS‐CoV‐2 and HCoV‐229E in vitro . The CZ‐MD provides a protective glycerol barrier containing cod trypsin as an ancillary component. Combined, these ingredients can inactivate common cold viruses in the throat and mouth. The CZ‐MD is believed to act on the viral surface proteins that would perturb their entry pathway into cells. The efficacy and safety of the CZ‐MD has been demonstrated in clinical trials on the common cold. Method of study The ability of the CZ‐MD to inactivate SARS‐CoV‐2 and HCoV‐229E was tested using an in vitro virucidal suspension test (ASTM E1052). Results CZ‐MD inactivated SARS‐CoV‐2 by 98.3% and HCoV‐229E by 99.9%. Conclusion CZ‐MD mouth spray can inactivate the respiratory coronaviruses SARS‐CoV‐2 and HCoV‐229E in vitro . Although the in vitro results presented cannot be directly translated into clinical efficacy, the study indicates that CZ‐MD might offer a protective barrier against SARS‐CoV‐2 and a decreased risk of COVID‐19 transmission. This article is protected by copyright. All rights reserved.

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Health risks to athletes at olympic and commonwealth games

Rossiter

2023

Occupational Medicine

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To the casual observer, an athlete attending a major games such as the Olympics, just turns up as usual and competes in the same way as every other competition. However, it is a unique event, in terms of pressure on the athlete and potential pitfalls (to athlete and staff), including physical and mental illness, as well as performance-related issues, which are different when compared to another single sport event.

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Coldzyme® Mouth Spray reduces duration of upper respiratory tract infection symptoms in endurance athletes under free living conditions

Abstract: The version in the Kent Academic Repository may differ from the final published version. Users are advised to check http://kar.kent.ac.uk for the status of the paper. Users should always cite the published version of record.

Cited by 16 publications

References 38 publications

Does Trypsin Oral Spray (Viruprotect®/ColdZyme®) Protect against COVID-19 and Common Colds or Induce Mutation? Caveats in Medical Device Regulations in the European Union

Does Trypsin Oral Spray (Viruprotect®/ColdZyme®) Protect against COVID-19 and Common Colds or Induce Mutation? Caveats in Medical Device Regulations in the European Union

Inactivation of SARS‐CoV‐2 and HCoV‐229E in vitro by ColdZyme® a medical device mouth spray against the common cold

Health risks to athletes at olympic and commonwealth games

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