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

Donatella Panatto, Andrea Orsi, Bianca Bruzzone, Valentina Ricucci, Guido Fedele, Giorgio Reiner, Nadia Giarratana, Alexander Domnich, Giancarlo Icardi, Stx Study Group, Donatella Panatto, Andrea Orsi, Bianca Bruzzone, Valentina Ricucci, Guido Fedele, Giorgio Reiner, Nadia Giarratana, Alexander Domnich, Giancarlo Icardi, Stx Study Group

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: COVID-19; SARS-CoV-2; Sentinox; efficacy; hypochlorous acid; randomized controlled trial; respiratory viruses; viral load.

Conflict of interest statement

D.P., A.O., B.B., V.R., A.D. and G.I. declare no conflict of interest. N.G. and G.R. are employees of APR Applied Pharma Research S.A. (Balerna, Switzerland). G.F. is a consultant of APR Applied Pharma Research S.A.

Figures

Figure 1
Figure 1
Flow chart of participants through the study.
Figure 2
Figure 2
Absolute change in viral loads in the intention-to-treat (ITT) population (n = 54), by study arm and day of follow-up (vertical bars represent standard errors).
Figure 3
Figure 3
Absolute change in viral loads in intention-to-treat (ITT) population by excluding subjects with high baseline viral loads (n = 15), by study arm and day of treatment (vertical bars represent standard errors).
Figure 4
Figure 4
Proportion of negativized subjects in the intention-to-treat (ITT) analysis, by negativization definition, study arm and day of follow-up.

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