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Sentinox 喷雾在降低轻度 COVID-19 病毒载量方面的疗效及其对其他呼吸道病毒的病毒杀灭活性:一项随机对照试验和体外研究的结果。

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.

机构信息

Department of Health Sciences (DISSAL), University of Genoa, 16132 Genoa, Italy.

Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.

出版信息

Viruses. 2022 May 12;14(5):1033. doi: 10.3390/v14051033.

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 log load reduction in groups STX-3 and STX-5 was 1.02 ( = 0.14) and 0.18 ( = 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 ( = 0.016) 2.01 log 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.

摘要

Sentinox(STX)是一种含有次氯酸的酸性氧化溶液,以喷雾形式呈现,其对 SARS-CoV-2 的病毒杀灭活性已得到证实。本文报道了一项针对轻度 COVID-19 患者使用 STX 降低病毒载量的疗效的随机对照试验(RCT)(NCT04909996)和一项关于其对不同呼吸道病毒活性的体外补充研究的结果。在 RCT 中,将 57 名患者随机(1:1:1)分为三组,分别接受 STX 每日三次(STX-3)、每日五次(STX-5)加标准治疗或仅接受标准治疗(对照组)。与对照组相比,STX-3 组和 STX-5 组的病毒载量对数减少分别为 1.02( = 0.14)和 0.18( = 0.80)。这些结果可能是由基线病毒载量极高的异常值驱动的。当考虑基线循环阈值为 20-30 的受试者时,STX-3 组的病毒载量显著( = 0.016)降低了 2.01 对数。STX-3 组治疗结束(第 5 天)时病毒检测阴性的患者比例明显高于对照组,提示病毒清除时间更短。STX 安全且耐受良好。在体外研究中,观察到针对常见呼吸道病毒的滴度降低了≥99.9%。STX 是一种安全的设备,具有广泛的病毒杀灭谱,可能降低轻度 COVID-19 患者的病毒载量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e19e/9144724/6d6181b58889/viruses-14-01033-g001.jpg

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