ClinicalTrials.gg
Enrolling by invitationNCT07739446Updated Sep 23, 2026

Effect of Surgical Masks in Preventing Acute Respiratory Infections

An interventional study of Surgical masks in Acute Respiratory Infections (ARIs), Influenza and COVID - 19, sponsored by Chiba University. Enrolling by invitation at 1 site in Japan. Open to participants aged 20 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Chiba University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
2,400
Allocation
Randomized
Ages
20 Years to 49 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • acute respiratory infections
  • influenza
  • COVID - 19
  • public health and social measures
  • surgical mask
  • medical mask
03

In context

Influenza, Human

2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.

This study's planned enrollment of 2,400 is above the median of 227 across 1,957 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Chiba University is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,400 participants (estimated)

Study arms

  • Experimental
    Surgical mask

    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

  • BehavioralSurgical masks

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

06

What researchers measure

Primary outcomes

  1. Acute respiratory infection

    Syndromic outcome based on self-report

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

Secondary outcomes

  1. Laboratory-confirmed influenza

    Laboratory-confirmed influenza based on testing done at healthcare facilities

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

  2. Laboratory-confirmed COVID-19

    Laboratory-confirmed COVID-19 based on testing done at healthcare facilities

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

  3. Laboratory-confirmed influenza or COVID-19

    Laboratory-confirmed influenza or COVID-19 based on testing done at healthcare facilities

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

Other outcomes

  1. Antibody response in sebum specimens

    Antibody response in sebum specimens collected for laboratory-confirmed influenza cases among participants

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

07

Study locations

1 site
  • Chiba University/National Institute of Infectious Diseases, Japan Institute for Health Security
    Chiba, Japan
08

References and documents

Individual participant data

Plan to share: No — The datasets generated and/or analyzed during the current study are not publicly available due to privacy regulations protecting participant confidentiality and identifiable data.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Mar 2027, 8 months after the start.

Of 146 non-industry interventional studies with no phase under Influenza, Human, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's planned 8 months is above that.

Counting every sponsor, half of 166 studies reached it within 6 months; a quarter within 3 and three quarters within 16.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2026
First posted
Jul 31, 2026
StartActual
Jul 31, 2026
Primary completionEst.
Mar 2027
CompletionEst.
Mar 2027
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07739446
Lead sponsor
Chiba University
Responsible party
Takeshi Arashiro (Associate Professor, Chiba University) — Principal investigator
First posted
Jul 31, 2026
Start date
Jul 31, 2026
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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