Effect of Surgical Masks in Preventing Acute Respiratory Infections

NCT07739446 | Enrolling By Invitation

• 1 other identifier: M10992
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Acute Respiratory Infections (ARIs); Influenza; COVID - 19

Keywords

acute respiratory infections; influenza; COVID - 19; public health and social measures; surgical mask; medical mask

Outcome Measures

Primary Outcomes (1)

• Laboratory-confirmed influenza

  Laboratory-confirmed influenza based on testing done at healthcare facilities

  From start of influenza season to the end of data collection at 14 weeks

Secondary Outcomes (3)

• Acute respiratory infection

  From start of influenza season to the end of data collection at 14 weeks

• Laboratory-confirmed COVID-19

  From start of influenza season to the end of data collection at 14 weeks

• Laboratory-confirmed influenza or COVID-19

  From start of influenza season to the end of data collection at 14 weeks

Other Outcomes (1)

• Antibody response in sebum specimens

  From start of influenza season to the end of data collection at 14 weeks

Study Arms (2)

Surgical mask

EXPERIMENTAL

Participants in this group are provided with masks and asked to wear them every day

Behavioral: Surgical masks

No intervention

NO INTERVENTION

Participants in this group are not provided with masks and are asked not to wear them every day

Interventions

Surgical masks BEHAVIORAL

Participants in this group are provided with masks and asked to wear them every day

Surgical mask

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiba University: lead

Study Sites (1)

Chiba University/National Institute of Infectious Diseases, Japan Institute for Health Security

Chiba, Japan

Location

MeSH Terms

Conditions

Influenza, Human; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)