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Study on reduction of salivary virus by povidone iodine on COVID-19

Study on reduction of salivary virus by povidone iodine on COVID-19

430

For hundred and thirty patients (mean age, 45.2 years; 243 [56.5%] male) were enrolled. One patient in the early treatment group and one in the delayed withdrew after randomization and was excluded from analysis. Two hundred and seventy-nine had a positive PCR on Day2.

Between November 30, 2020 and March 17, 2021, 432 patients signed the informed consent form. Four hundred and thirty participants were enrolled and randomly assigned to a treatment group (215 to the early gargling and 215 to the delayed).

There was an adverse event that may have been associated with the drug with oropharyngeal discomfort.

Primary endpoint: The clearance rate of SARS-CoV-2 of saliva on day 5 was 34.5% in the early interventional group and 21.4% in the late interventional group, with the clearance rate in the early interventional group significantly higher than that in the delayed gargling group (p=0.015). Secondary endpoint: The SARS-CoV-2-clearance rate in saliva on day 6 was 41.3% in the early mouthwash and gargling group and 36.8% in the late one. In the delayed gargling group that started gargling with PVP-I on the day 5, the virus clearance rate on the day 6 approached that of the early gargling group, and a significant difference was lost between the two groups. Investigational endpoint: Of the 139 PCR positive patients in the early gargling group and 140 PCR positive patients in the delayed gargling group on day 2, the saliva from 4 and 13 patients on day 5 showed cytopathic effect to Vero E6, respectively, resulted in the early gargling intervention significantly reduced infectivity to Vero E6 (p = 0.025).

430participants were enrolled into this study. PVP-I gargling significantly improved viral clearance and infectivity by the day 5.

April. 15, 2022

No

https://jrct.niph.go.jp/latest-detail/jRCT1051200078

Matsuyama Akifumi

Osaka Habikino Medical Center, Osaka Prefectural Hospital Organization

3-7-1,Habikino,Habikino-shi,Osaka

akifumi-matsuyama@umin.ac.jp

Matsuyama Akifumi

Osaka Habikino Medical Center, Osaka Prefectural Hospital Organization

3-7-1,Habikino,Habikino-shi,Osaka

+81-729572121

covid-19@ra.opho.jp

Complete

Nov. 24, 2020

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

other

(1) Subjects who are 16 years old or older on the date of consent acquisition and who have obtained the consent of the substitute if they are 16 years old or older and less than 20 years old
(2) Sex; male or female
(3) quarantine at the hotel
(4) Meets all of 1)-3) below
1) Subjects whose Asymptomatic/mild case has at least one RT-PCR test positive for SARS-CoV-2 from pharyngeal swab, nasopharyngeal swab or saliva.
2) Subjects who can gargle
3) Subjects who will be quarantined for 6days or more
(5) Subjects who have obtained written consent voluntarily to participate in the trial

(1) Subjects who are on thyroid hormone preparation
(2) Subjects who have Iodine allergy
(3) Pregnant
(4) Lactating female
(5) Gargling with Povidone iodine before entry

Both

COVID-19 infection

The intervention is a gargle or a water gargle with a 15-fold diluted gargle solution containing 7% gargle of povidone iodine. Povidone-iodine early gargle group was instructed to perform povidone-iodine gargle from the 2nd day to 6th day of treatment, and in povidone-iodine delayed gargle group, water gargle from 2nd to 4th day of medical treatment, and 5th and 6th day. Povidone Iodine is instructed to gargle. The gargle should be performed after waking up and before sampling, before lunch, before dinner, and before going to bed.

COVID-19 infection

C000657245

Among the subjects in which the virus was detected by RT-PCR of saliva samples on the 2nd day of accommodation treatment, the negative rate of SARS-CoV-2 virus by RT-PCR of saliva on the 5th day of accommodation treatment.

Among the subjects in which the virus was detected by RT-PCR of saliva samples on the 2nd day of accommodation treatment, the negative rate of SARS-CoV-2 virus by RT-PCR of saliva on the 6th day of accommodation treatment.

+81-6-6692-1201

Nov. 12, 2020

none