Effect of Surgical Masks in Preventing Acute Respiratory Infections | NCT07739446

NCT07739446

Overview

NCT ID: NCT07739446
Lead Sponsor: Chiba UniversityOTHER
Official Title: Randomized Controlled Trial to Evaluate the Efficacy of Surgical Masks in Preventing Acute Respiratory Infections
Brief Summary: The goal of this clinical trial is to evaluate the efficacy of surgical masks in preventing acute respiratory tract infections. The main question it aims to answer is:

- Does wearing a mask prevent you from getting acute respiratory tract infections, including influenza and COVID-19

Researchers will compare a surgical mask to no intervention to see if wearing a mask works to prevent acute respiratory infection.

Participants will:

Wear or not wear a surgical mask every day

Answer a questionnaire every 2 weeks on symptoms, testing status, and behaviors

This trial does not assess if wearing a mask prevents transmission of pathogens when you are already sick. Also, the trial does not assess whether universal masking (where everyone wears masks) works.
Conditions

Status and Timeline

Status: Enrolling by invitation
Last Update Posted: Aug 3, 2026Actual
Start Date: Jul 2026Estimated
Primary Completion Date: Mar 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Those who originally do not wear a mask during the influenza season

Those aged 20 years or older and under 50 years at the time of providing informed consent

If assigned to the mask group, those who can agree to wear a mask when going outdoors for 3 to 4 months during the influenza season (excluding times such as when eating)

In the case of the non-mask group, those who can agree, in principle, not to wear a mask for 3 to 4 months during the influenza season

Those who can agree to undergo testing for both influenza and COVID-19 on the day of onset or the following day if symptoms suggestive of influenza, COVID-19, or a common cold (such as fever or respiratory symptoms) develop, and to visit a medical institution at their own expense for medical fees

Those who usually go out 3 or more days a week

Those who have obtained the agreement of cohabiting family members regarding participation

Those who, after receiving a thorough explanation regarding participation in this study and with full understanding, have provided written informed consent based on their own free will

Exclusion Criteria:

Those who originally wear a mask during the influenza season and intend to continue doing so in the future

Those who are engaged in healthcare, food manufacturing, etc., and wear a mask during regular work

Those who are pregnant

Those with underlying medical conditions such as chronic liver disease, cancer, or cardiovascular disease

Those who have previously experienced allergic symptoms when wearing commercially available non-woven masks

Those who are planning long-term overseas travel exceeding one week during the influenza season, including the New Year holidays‡

Others who did not provide consent

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 2,000Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Chiba University/National Institute of Infectious Diseases, Japan Institute for Health Security

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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