Center for reverse Translational Research, Osaka Habikino Medical Center, Osaka Prefectural Hospital Organization, 3-7-1 Habikino, Habikino, Osaka, 583-8588, Japan.
Center for Clinical Research, Osaka Habikino Medical Center, Osaka Prefectural Hospital Organization, Habikino, Japan.
Sci Rep. 2022 Nov 28;12(1):20449. doi: 10.1038/s41598-022-24683-8.
Povidone-iodine (PVP-I) is a broad-spectrum antiseptic reagent that has been used for over 50 years. The purpose of this study is to look into the effect of gargling with PVP-I gargling on virus clearance and saliva infectivity in COVID-19. A prospective, randomized, open-label trial of intervention with PVP-I was conducted at three quarantine facilities in Osaka, Japan, enrolling adolescents and adults with asymptomatic-to-mild COVID-19. Patients were randomly allocated to the early and late intervention group at a 1:1 ratio. The early group gargled with PVP-I from days 2 to day 6; the late group gargled with water first, then with PVP-I from day 5 after sampling till day 6. The primary and secondary endpoints were viral clearance for SARS-CoV-2 using RT-qPCR at days 5 and 6, respectively, and the investigational endpoint was saliva infectivity clearance on day5. We enrolled 430 participants, with 215 assigned to each group, and 139 in the early group and 140 in the late had a positive saliva RT-qPCR test on day 2. On day 5, the early group had a significantly higher RT-qPCR negative rate than that of the late group (p = 0.015), and the early had a significantly higher clearance rate of infectivity (p = 0.025). During the PVP-I intervention, one participant reported oropharyngeal discomfort. Gargling with PVP-I may hasten virus clearance and reduce viral transmission via salivary droplets and aerosols in patients with asymptomatic-to-mild COVID-19. (Clinical trial registration numbers: jRCT1051200078 and dateof registration: 24/11/2020).
聚维酮碘（PVP-I）是一种广谱消毒剂，已经使用了 50 多年。本研究旨在探讨漱口用聚维酮碘漱口对 COVID-19 患者病毒清除和唾液传染性的影响。在日本大阪的三个检疫设施中，进行了一项前瞻性、随机、开放标签的 PVP-I 干预试验，招募了无症状至轻度 COVID-19 的青少年和成年人。患者以 1:1 的比例随机分配到早期和晚期干预组。早期组在第 2 天至第 6 天用 PVP-I 漱口；晚期组先用清水漱口，然后在采样后第 5 天至第 6 天用 PVP-I 漱口。主要和次要终点分别为第 5 天和第 6 天使用 RT-qPCR 检测 SARS-CoV-2 的病毒清除率，研究终点为第 5 天唾液传染性清除率。我们共招募了 430 名参与者，每组 215 名，其中早期组 139 名，晚期组 140 名，第 2 天有 139 名唾液 RT-qPCR 检测阳性。第 5 天，早期组的 RT-qPCR 阴性率明显高于晚期组（p=0.015），早期组的传染性清除率明显高于晚期组（p=0.025）。在 PVP-I 干预期间，有 1 名参与者报告了口咽不适。在无症状至轻度 COVID-19 患者中，用聚维酮碘漱口可能会加速病毒清除，并减少通过唾液飞沫和气溶胶传播的病毒。（临床试验注册号：jRCT1051200078 和注册日期：2020 年 11 月 24 日）。
