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Can a simple mask stop the flu? 2,000 volunteers put it to the test

NCT ID NCT07739446

Prevention Sponsor: Chiba University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This trial asks whether wearing a surgical mask every day can prevent acute respiratory infections like influenza and COVID-19. About 2,000 adults who normally don't wear masks will be randomly assigned to either wear a mask when outdoors or continue without one for 3–4 months during flu season. Participants will report symptoms and testing results every two weeks. The study focuses on whether masks protect the wearer, not on preventing transmission from sick individuals or the effects of universal masking.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Surgical masks worn daily
What this could lead to
If wearing a mask every day proves effective, it could support simple, low-cost guidance for reducing flu and COVID-19 infections during respiratory season.
What could go wrong
This trial only tests personal protection, not preventing spread from sick people or universal masking. Results may vary by adherence and virus activity, and the study is not designed to prove masks work in all settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 49 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

COVID-19 influenza respiratory tract infectious disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute respiratory infections (ARIS) COVID-19 Influenza

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Chiba, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.