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Enrolling by invitation NCT07739446

Effect of Surgical Masks in Preventing Acute Respiratory Infections

No phase Interventional Acute Respiratory Infections (ARIs) Influenza COVID - 19

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgical masks.
Who it may be relevant to
Registry conditions: Acute Respiratory Infections (ARIs), Influenza, COVID - 19. Basic parameters: 20 years — 49 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Randomized Controlled Trial to Evaluate the Efficacy of Surgical Masks in Preventing Acute Respiratory Infections

Overview

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.

Interventions

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

Primary outcome measures

  • Laboratory-confirmed influenza [Time frame: From start of influenza season to the end of data collection at 14 weeks]
Secondary outcome measures (3)
  • Acute respiratory infection [Time frame: From start of influenza season to the end of data collection at 14 weeks]
  • Laboratory-confirmed COVID-19 [Time frame: From start of influenza season to the end of data collection at 14 weeks]
  • Laboratory-confirmed influenza or COVID-19 [Time frame: From start of influenza season to the end of data collection at 14 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Japan · 1 center
  • Chiba University/National Institute of Infectious Diseases, Japan Institute for Health Sec — Chiba

Identifiers

NCT: NCT07739446 · M10992

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗