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

Phase 2

• Conditions: COVID-19 infection; C000657245

• Registration Number: JPRN-jRCT1051200078
• Lead Sponsor: Matsuyama Akifumi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-24
• Study Completion: 2021-03-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

(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

Exclusion Criteria

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.