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

Suzy Huijghebaert, Guido Vanham, Myriam Van Winckel and Karel Allegaert
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Suzy Huijghebaert: Independent Researcher, 1310 La Hulpe, Belgium
Guido Vanham: Department of Virology, Institute of Tropical Medicine, 2000 Antwerp, Belgium
Myriam Van Winckel: Department of Paediatrics, Ghent University Hospital and Ghent University, 9000 Ghent, Belgium
Karel Allegaert: Department of Development and Regeneration, KU Leuven, 3000 Leuven, Belgium

IJERPH, 2021, vol. 18, issue 10, 1-15

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: trypsin; medical device; oral spray; common cold; COVID-19; safety; mutations (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
References: View complete reference list from CitEc
Citations: View citations in EconPapers (1)

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