Protocol for a Randomized, Open-Label Clinical Trial on the Effect of Mouthwash on Salivary SARS-CoV-2 Load

Author:

Konishi Keiji12ORCID,Onozuka Daisuke12ORCID,Takatera Satoko12,Matsuo Hiroo2ORCID,Yoshida Hisao2,Hamaguchi Shigeto234,Yamamoto Shungo245,Sada Ryuichi Minoda245ORCID,Suzuki Koichiro6ORCID,Kutsuna Satoshi12345ORCID

Affiliation:

1. Department of Oral Microbe Control, Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan

2. Department of Infection Control and Prevention, Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan

3. Department of Transformative Analysis for Human Specimen, Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan

4. Division of Fostering Required Medical Human Resources, Center for Infectious Disease Education and Research (CiDER), Osaka University, Osaka 565-0871, Japan

5. Department of Transformative Protection to Infectious Disease, Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan

6. The Research Foundation for Microbial Diseases of Osaka University (BIKEN), Osaka 565-0871, Japan

Abstract

Mouthwashes containing cetylpyridinium chloride (CPC) or on-demand aqueous chlorine dioxide (ACD) have potential to reduce the salivary severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) load in individuals with SARS-CoV-2 infection. This study will evaluate the effect of CPC and on-demand ACD mouthwashes on salivary SARS-CoV-2 levels in individuals with acute asymptomatic or mild SARS-CoV-2 infection (COVID-19) staying in a residential recuperation facility in Osaka, Japan. This randomized, open-label clinical trial will include three equal-sized groups (CPC mouthwash, on-demand ACD mouthwash, and placebo), with 30 participants per group. A stratified replacement block method will be used to ensure balanced allocation based on symptom presence and days since symptom onset. Participants will use mouthwash at set times for 7 days or until the end of recuperation. Saliva samples will be collected at multiple time points and tested for SARS-CoV-2 using quantitative reverse transcription polymerase chain reaction. The primary outcome will be changes in salivary SARS-CoV-2 viral load 2 h after the first mouthwash use compared with the pre-mouthwash level. Secondary outcomes will include changes in salivary viral load and clinical parameters at different time points. This study was registered with the Japan Registry of Clinical Trials on 18 October 2022 (jRCTs051220107).

Funder

Earth Corporation, Tokyo, Japan

Publisher

MDPI AG

Subject

Paleontology,Space and Planetary Science,General Biochemistry, Genetics and Molecular Biology,Ecology, Evolution, Behavior and Systematics

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