Acute Respiratory Infections (ARIs)NCT07739446
Effect of Surgical Masks in Preventing Acute Respiratory Infections
A study testing Surgical masks in people with Acute Respiratory Infections (ARIs) and Influenza, run by Chiba University at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Infections (ARIs), Influenza, COVID - 19
- What is being tested?
- Surgical masks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteJapan
- Study dates
- 31 Jul 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site
Chiba University/National Institute of Infectious Diseases, Japan Institute for Health Security
Chiba
About this study
Official title: Randomized Controlled Trial to Evaluate the Efficacy of Surgical Masks in Preventing Acute Respiratory Infections
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
Read more
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
- Being tested
- Surgical masks
- Keywords
- acute respiratory infections, influenza, COVID - 19, public health and social measures, surgical mask, medical mask
- Medical subject headings
- Influenza, Human, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical masksBehavioural
Participants in this group are provided with masks and asked to wear them every day
| Study group | Role | What they receive |
|---|---|---|
| Surgical mask | Experimental | Participants in this group are provided with masks and asked to wear them every day Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute respiratory infection
Syndromic outcome based on self-report
Measured: From start of influenza season to the end of data collection at 14 weeks
Secondary outcomes (3)
Laboratory-confirmed influenza
Laboratory-confirmed influenza based on testing done at healthcare facilities
Measured: From start of influenza season to the end of data collection at 14 weeks
Laboratory-confirmed COVID-19
Laboratory-confirmed COVID-19 based on testing done at healthcare facilities
Measured: From start of influenza season to the end of data collection at 14 weeks
Laboratory-confirmed influenza or COVID-19
Laboratory-confirmed influenza or COVID-19 based on testing done at healthcare facilities
Measured: From start of influenza season to the end of data collection at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start31 Jul 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Infections (ARIs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiba University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takeshi Arashiro, Chiba University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739446
- Sponsor's protocol ID
- M10992
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Efficacy of Surgical Masks in Preventing Acute Respiratory Infections
- ClinicalTrials.gov ID
- NCT07739446
- Acronym / sponsor ID
- M10992
- Conditions
- Acute Respiratory Infections (ARIs), Influenza, COVID - 19
- Keywords
- acute respiratory infections, influenza, COVID - 19, public health and social measures, surgical mask, medical mask
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Chiba UniversityUniversity, hospital or other
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical mask | Experimental | Behavioral: Surgical masksParticipants in this group are provided with masks and asked to wear them every day |
| No intervention | No intervention | –Participants in this group are not provided with masks and are asked not to wear them every day |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical masksParticipants in this group are provided with masks and asked to wear them every day | Behavioural | Surgical mask |
Primary outcome
Acute respiratory infection
Time frame: From start of influenza season to the end of data collection at 14 weeks
Syndromic outcome based on self-report
3 secondary outcomes
Laboratory-confirmed influenza
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical masks in people with Acute Respiratory Infections (ARIs) and Influenza, run by Chiba University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute respiratory infection (time frame: From start of influenza season to the end of data collection at 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.