Clinical Trial: Health Impact Investigation of Ionless (Hypochlorous Acid Water) Space Spraying (Japan)

Tokyo, June 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061827) titled 'Health Impact Investigation of Ionless (Hypochlorous Acid Water) Space Spraying' on June 8.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - Iwate Medical University

Condition: Condition - Adverse events (eye itching, eye redness, sore throat, runny nose, cough, odor of hypochlorous acid solution, stress caused by the sound of the nebulizer) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to investigate whether the use of Ionless (hypochlorous acid water) for space spraying in hospital rooms has any health effects on inpatients. As background, there have been numerous cases of inpatients contracting COVID-19 within the hospital in addition to their original treatment, resulting in prolonged hospital stays or death due to poor prognosis. Aerosol transmission, one of the primary routes of transmission for COVID-19, occurs when a person inhales viruses suspended in the air. Therefore, as a measure to prevent infection, it is necessary to reduce the concentration of viruses within a given space. To remove the viruses themselves, hypochlorous acid water-based humidifiers and hypochlorous acid water for use in humidifiers are commercially available from multiple manufacturers and are widely used in medical institutions. In contrast, according to the results of a survey on health hazards conducted by the Japan Poison Information Center, while there have been reports of accidents involving products that claim to disinfect the air using chlorine dioxide (formed by the oxidation of chlorite), there have been no reports of health hazards resulting from the aerial spraying of hypochlorous acid water. However, since hypochlorous acid water is classified as a general merchandise item under the Pharmaceutical and Medical Devices Act, there is a lack of data on the efficacy and safety of its aerial spraying. Therefore, we will conduct a pilot study that could provide preliminary data on its safety in the presence of people. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Hypochlorous Acid Water Spray Group: Set the spray program settings on the CL Mist L humidifier manufactured by Nipro Corporation so that the effective chlorine concentration in the air reaches 0.02 ppm during the spray period. Based on experiments conducted in patient rooms at the Uchimaru Medical Center, three units each of humidifiers and circulators will be used in four-bed rooms, one unit each in single rooms, and two units each in two-bed rooms. Additionally, the ventilation system in all patient rooms will be set to the low setting. Since the ambient chlorine concentration and indoor humidity are proportional during atomization, the measured indoor humidity value at an effective chlorine concentration of 0.02 ppm is set and verified through daily humidity measurements on the indoor environment check sheet. The humidification time is set for 12 hours, from 8:00 AM to 8:00 PM. This will be conducted for 30 days. Co-investigator Mikio Takahashi will measure and verify the effective chlorine concentration once a week starting from the first day of atomization. Interventions/Control_2 - Tap Water Spray Group (Placebo) Since the effective chlorine concentration in tap water is below the detection limit, the humidity conditions will be set to match those of the hypochlorous acid water group at an effective chlorine concentration of 0.02 ppm. The humidification period is set for 12 hours, from 8:00 a.m. to 8:00 p.m. The experiment will be conducted for 30 days. The spraying conditions are the same as those for the hypochlorous acid spray group.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - The study population consists of patients hospitalized at Uguisu-juku Onsen Hospital during the enrollment period who are capable of communicating, understand the study protocol, and have expressed a willingness to participate (proxy signing of the informed consent form is permitted). Patients must not exhibit any of the following symptoms: itchy eyes, red eyes, sore throat, runny nose, or cough. Key exclusion criteria - Patients whom the principal investigator has determined to be unsuitable as study participants. Target Size - 32

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2023 Year 09 Month 20 Day Date of IRB - 2023 Year 08 Month 25 Day Anticipated trial start date - 2023 Year 10 Month 01 Day Last follow-up date - 2023 Year 12 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070704

Disclaimer: Curated by HT Syndication.