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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112496
Enrollment
Unknown
Registered
2025-11-14
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory infectious disease

Interventions

Control Group: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 Group 1: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
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
Intervention Group 2: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

Sponsors

Beijing Center for Disease Prevention and Control
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Secondary Attack Rate of laboratory confirmed infection;

Secondary

MeasureTime frame
Secondary Attack Rate of clinically diagnosed infection;Severity, hospitalization and death;

Countries

China

Contacts

Public ContactYing Shen

Beijing Center for Disease Prevention and Control

amandashy@163.com+86 188 1118 1087

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026