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.
Int J Environ Res Public Health
; 18(10)2021 05 11.
Article
in English
| MEDLINE | ID: covidwho-1328101
ABSTRACT
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 SARS-CoV-2 infectivity and syncytia formation in host models, while culture passages in trypsin presence induce spike protein mutants. The manufacturer claims >98% SARS-CoV-2 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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Common Cold
/
COVID-19
Type of study:
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Year:
2021
Document Type:
Article
Affiliation country:
Ijerph18105066
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