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Efficacy of the Sentinox Spray in Reducing Viral Load in Mild COVID-19 and Its Virucidal Activity against Other Respiratory Viruses: Results of a Randomized Controlled Trial and an In Vitro Study
Authors:Donatella Panatto  Andrea Orsi  Bianca Bruzzone  Valentina Ricucci  Guido Fedele  Giorgio Reiner  Nadia Giarratana  Alexander Domnich  Giancarlo Icardi  STX Study Group
Affiliation:1.Department of Health Sciences (DISSAL), University of Genoa, 16132 Genoa, Italy; (D.P.); (A.O.); (G.I.);2.Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy; (B.B.); (V.R.);3.NG Scientific Consulting, 20091 Bresso, Italy;4.APR Applied Pharma Research SA, via Corti 5, CH-6828 Balerna, Switzerland; (G.R.); (N.G.)
Abstract:Sentinox (STX) is an acid-oxidizing solution containing hypochlorous acid in spray whose virucidal activity against SARS-CoV-2 has been demonstrated. In this paper, results of a randomized controlled trial (RCT) on the efficacy of STX in reducing viral load in mild COVID-19 patients (NCT04909996) and a complementary in vitro study on its activity against different respiratory viruses are reported. In the RCT, 57 patients were randomized (1:1:1) to receive STX three (STX-3) or five (STX-5) times/day plus standard therapy or standard therapy only (controls). Compared with controls, the log10 load reduction in groups STX-3 and STX-5 was 1.02 (p = 0.14) and 0.18 (p = 0.80), respectively. These results were likely driven by outliers with extreme baseline viral loads. When considering subjects with baseline cycle threshold values of 20–30, STX-3 showed a significant (p = 0.016) 2.01 log10 reduction. The proportion of subjects that turned negative by the end of treatment (day 5) was significantly higher in the STX-3 group than in controls, suggesting a shorter virus clearance time. STX was safe and well-tolerated. In the in vitro study, ≥99.9% reduction in titers against common respiratory viruses was observed. STX is a safe device with large virucidal spectrum and may reduce viral loads in mild COVID-19 patients.
Keywords:hypochlorous acid   Sentinox   COVID-19   SARS-CoV-2   respiratory viruses   viral load   randomized controlled trial   efficacy
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