Randomized Controlled Trial to Evaluate the Efficacy of Surgical Masks in Preventing Acute Respiratory Infections
| Registry | NCT07739446 |
|---|---|
| Status | Enrolling by invitation |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 2400 (Estimated) |
| Sponsor | Chiba University (Other) |
| Conditions | Acute Respiratory Infections (ARIs), Influenza, COVID - 19 |
| Interventions | Surgical masks (Behavioral) |
| Dates | start 2026-07-31, primary completion 2027-03-01 (estimated), completion 2027-03-01 (estimated), first posted 2026-07-31, last updated 2026-09-23 |
| Locations | 1 site in Japan |
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All trials for Acute Respiratory Infections (ARIs) All trials for Influenza All trials of Surgical masks
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Surgical mask | Experimental | Behavioral: Surgical masks | Participants 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 |
Sex: All, ages: 20 Years to 49 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Chiba University/National Institute of Infectious Diseases, Japan Institute for Health Security | Chiba | Japan |