Randomized Controlled Trial to Evaluate the Efficacy of Surgical Masks in Preventing Acute Respiratory Infections
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Laboratory-confirmed influenza
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
No intervention
Participants in this group are not provided with masks and are asked not to wear them every day
Surgical mask
Participants in this group are provided with masks and asked to wear them every day
干预措施: Surgical masks (Behavioral)
结局指标
主要结局
Laboratory-confirmed influenza
时间窗: From start of influenza season to the end of data collection at 14 weeks
Laboratory-confirmed influenza based on testing done at healthcare facilities
次要结局
- Acute respiratory infection(From start of influenza season to the end of data collection at 14 weeks)
- Laboratory-confirmed COVID-19(From start of influenza season to the end of data collection at 14 weeks)
- Laboratory-confirmed influenza or COVID-19(From start of influenza season to the end of data collection at 14 weeks)
研究者
Takeshi Arashiro
Associate Professor
Chiba University