ChiCTR2500112496 版本V1.0 版本创建时间2025/11/14 16:34:53 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500112496 

最近更新日期：

Date of Last Refreshed on：

 2025-11-14 16:34:45 

注册时间：

Date of Registration：

 2025-11-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

医用外科口罩预防呼吸道病原体传播、感染的有效性：以家庭为单位的整群随机对照试验

Public title：

Effectiveness of Surgical Masks in Preventing Household Transmission of Respiratory Viral Infections: A Cluster-Randomized Controlled Trial in Community Settings

注册题目简写：

English Acronym：

研究课题的正式科学名称：

医用外科口罩预防呼吸道病原体传播、感染的有效性：以家庭为单位的整群随机对照试验

Scientific title：

Effectiveness of Surgical Masks in Preventing Household Transmission of Respiratory Viral Infections: A Cluster-Randomized Controlled Trial in Community Settings

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

沈莹 

研究负责人：

沈莹 

Applicant：

Ying Shen 

Study leader：

Ying Shen 

申请注册联系人电话：

Applicant telephone：

 +86 188 1118 1087

研究负责人电话：

Study leader's
telephone：

+86 188 1118 1087

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 amandashy@163.com

研究负责人电子邮件：

Study leader's E-mail：

 amandashy@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市和平里中街39号

研究负责人通讯地址：

北京市和平里中街39号

Applicant address：

No. 39, Hepingli Middle Street, Dongcheng District, Beijing

Study leader's address：

No. 39, Hepingli Middle Street, Dongcheng District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

 100013

研究负责人邮政编码：

Study leader's postcode：

 100013

申请人所在单位：

北京市疾病预防控制中心

Applicant's institution：

Beijing Center for Disease Prevention and Control

研究负责人所在单位：

北京市疾病预防控制中心

Affiliation of the Leader：

Beijing Center for Disease Prevention and Control

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 BJCDC2025033

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

北京市疾病预防控制中心伦理委员会

Name of the ethic committee：

Ethic Committee of Beijing Center for Disease Prevention and Control

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-10-09 00:00:00

伦理委员会联系人：

邱倩

Contact Name of the ethic committee：

Qian Qiu

伦理委员会联系地址：

北京市东城区和平里中街39号

Contact Address of the ethic committee：

No. 39, Hepingli Middle Street, Dongcheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 152 0150 7816

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

北京市疾病预防控制中心

Primary sponsor：

Beijing Center for Disease Prevention and Control

研究实施负责（组长）单位地址：

北京市东城区和平里中街39号

Primary sponsor's address：

No. 39, Hepingli Middle Street, Dongcheng District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

北京市疾病预防控制中心

具体地址：

北京市东城区和平里中街39号

Institution
hospital：

Beijing Center for Disease Prevention and Control

Address：

No. 39, Hepingli Middle Street, Dongcheng District, Beijing

经费或物资来源：

科研经费

Source(s) of funding：

through program funding.

研究疾病：

呼吸道传染病  

Target disease：

respiratory infectious disease

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

呼吸道感染仍是全球公共卫生领域的核心挑战之一。尤其在季节性流感、新型冠状病毒等呼吸道病毒交替流行的背景下，持续对医疗资源造成压力。这类病毒主要通过飞沫、直接和间接接触、气溶胶传播，口罩作为简便、低成本的非药物干预手段，长期以来被推荐用于阻断病毒传播。然而，关于口罩在非医疗环境中的实际防护效果，目前仍存争议。家庭环境被广泛认为是呼吸道病毒传播最易发生、且传播效率最高的场景。因此，开展以家庭为单位的随机对照试验，明确医用外科口罩在家庭环境中预防呼吸道病原体传播的具体效果，为制定预防常见呼吸道传染病及具有潜在大流行风险的呼吸道病原体流行的防控策略提供科学依据。  

Objectives of Study：

Respiratory infections remain one of the core challenges in global public health. Particularly under the alternating circulation of respiratory viruses such as seasonal influenza and novel coronaviruses, these infections continue to exert substantial pressure on healthcare systems. Such viruses are primarily transmitted via droplets, direct and indirect contact, and aerosols. As a simple and low-cost non-pharmaceutical intervention, mask use has long been recommended to interrupt viral transmission. However, the actual protective effectiveness of masks in non-medical community settings remains controversial. The household setting is widely recognized as one of the most favorable environments for respiratory virus transmission, with high efficiency of spread. Therefore, conducting a randomized controlled trial at the household level to determine the specific effectiveness of medical surgical masks in preventing the transmission of respiratory pathogens within households will provide scientific evidence for developing prevention and control strategies against common respiratory infectious diseases and emerging pathogens with pandemic potential.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.北京市常住居民（居住>=6个月）； 2.指示病例于就诊前3天出现符合ILI定义的症状（体温>=38℃，伴咳嗽或咽痛之一）； 3. 指示病例经多重PCR检测，至少确诊感染一种急性呼吸道病原体（流感、SARS-CoV-2、RSV、HPIV、腺病毒、鼻病毒、普通冠状病毒、偏肺病毒、肺炎支原体） 4. 家庭>=2人，且无5岁及以下儿童； 5. 所有家庭成员愿意配合干预、采样并签署知情同意书。

Inclusion criteria

1. Permanent residents of Beijing (living >=6 months); 2. The index case developed symptoms meeting the ILI definition (temperature >=38℃ with either cough or sore throat) within 3 days before seeking medical care; 3. The index case was tested by multiple PCR assays and confirmed to be infected with at least one acute respiratory pathogen (influenza, SARS-CoV-2, RSV, HPIV, adenovirus, rhinovirus, common coronavirus, human metapneumovirus, or Mycoplasma pneumoniae); 4. Household of >=2 people, with no children aged 5 years or younger; 5. All household members are willing to cooperate with interventions, sampling, and sign informed consent forms.

排除标准：

1.指示病例发病超过3天 ; 2.指示病例发病前一周至现在，家庭成员曾出现满足符合呼吸道疾病定义的症状; 3.指示病例或家庭成员存在严重精神障碍或呼吸系统疾病等无法配合佩戴口罩; 4.非北京市常住居民; 5.拒绝参与干预和样本采集的个体 .

Exclusion criteria：

1. The index case has been ill for more than 3 days; 2. From one week before the onset of the index case to the present, family members have shown symptoms that meet the definition of a respiratory disease; 3. The index case or family members have severe mental disorders or respiratory system diseases that prevent them from wearing a mask properly; 4. Non-permanent residents of Beijing; 5. Individuals who refuse to participate in interventions and sample collection.

研究实施时间：

Study execute time：

从 From 2025-11-17 00:00:00至 To 2026-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-01 00:00:00 至 To 2026-05-31 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 150

Group：

Control Group

Sample size：

干预措施：

不提供口罩，不要求病例及其家庭成员佩戴口罩，家庭成员维持常规生活方式。

干预措施代码：

Intervention：

No masks will be provided, and neither the index case nor household members will be required to wear masks; household members will continue their usual lifestyle.

Intervention code：

组别：

干预组1

样本量：

 150

Group：

Intervention Group 1

Sample size：

干预措施：

提供口罩，调查期间病例与家庭成员处于同一房间时，病例需持续佩戴医用外科口罩，每4小时更换一个口罩，口罩破损、变湿时随时更换，家庭成员不需佩戴。家庭中出现新发病例时，新发病例也应按此要求及时佩戴口罩。家庭指示病例如为6-18岁人群，如同意佩戴，调查继续开展，如不同意佩戴，则不纳入此调查。家庭新发病例如为6-18岁人员，如同意佩戴，则调查继续开展，如不同意佩戴，则调查终止。就寝时如病例与家庭成员处于同一房间，病例不需佩戴口罩。

干预措施代码：

Intervention：

Masks will be provided. During the study period, when the index case and household members are in the same room, the index case is required to continuously wear a medical surgical mask, replacing it every 4 hours or immediately if the mask becomes damaged or wet. Household members are not required to wear masks. If new cases occur within the household, the newly affected individuals must also wear masks according to the same requirements. For index or new cases aged 6–18 years: If they agree to wear a mask, the study will continue; If they refuse to wear a mask, they will not be included (index case) or the study will terminate (new case). During sleep, if the index case and household members share the same room, the index case is not required to wear a mask.

Intervention code：

组别：

干预组2

样本量：

 150

Group：

Intervention Group 2

Sample size：

干预措施：

提供口罩，调查期间病例与家庭成员处于同一房间，全部人员均需持续佩戴医用外科口罩，每4小时更换一个口罩，或口罩破损、变湿时随时更换。房间内无病例仅家庭成员共处同一房间时不需佩戴口罩。家庭成员中6-18岁人员建议佩戴口罩，但不强制要求。就寝时如病例与家庭成员处于同一房间，病例和家庭成员均不需佩戴口罩。

干预措施代码：

Intervention：

Masks will be provided. During the study period, when the index case and household members are in the same room, all individuals are required to continuously wear medical surgical masks, replacing them every 4 hours or immediately if the mask becomes damaged or wet. When household members are in a room together without the presence of the index case, masks are not required. Household members aged 6–18 years are encouraged to wear masks, but it is not mandatory. During sleep, if the index case and household members share the same room, neither the index case nor the household members are required to wear masks.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

 北京 

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

 北京市疾病预防控制中心 

单位级别：

 无 

Institution
hospital：

Beijing Center for Disease Prevention and Control

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

家庭成员经实验室确诊的流感病毒、SARS-CoV-2等呼吸道病毒感染续发率。

指标类型：

主要指标

Outcome：

Secondary Attack Rate of laboratory confirmed infection

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床诊断呼吸道疾病续发率

指标类型：

次要指标

Outcome：

Secondary Attack Rate of clinically diagnosed infection

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

全部病例重症、住院及死亡情况

指标类型：

次要指标

Outcome：

Severity, hospitalization and death

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

口罩佩戴的不良事件发生情况

指标类型：

副作用指标

Outcome：

Incidence of adverse events of mask wearing

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

咽拭子

组织：

Sample Name：

throat swab

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究在家庭为单位进行随机分组，采用区块随机化方法，区块大小为 6，以保证三组（A、B、C）在每个区块内人数相对平衡。每个区块内各组受试者人数固定（每组 2 人），具体分配顺序通过计算机随机生成，由独立研究人员负责生成随机序列。

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study performed random grouping at the household level using a block randomization method with a block size of 6 to ensure that the number of participants in the three groups (A, B, C) was relatively balanced within each block. The number of participants in each group within a block was fixed (2 per group), and the specific allocation order was randomly generated by a computer and managed by an independent researcher.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

数据通过纸制的问卷采集，专人管理

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data will be collected using paper-based questionnaires and managed by dedicated personnel.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-11-14 16:34:45