The Protective Effect of Mask Wearing Against Respiratory Tract Infections

Norwegian Institute of Public Health

Status: Completed

Conditions: COVID-19; Respiratory Tract Infections

Treatments: Behavioral: Wearing face masks

Study type: Interventional

Funder types: Other

Identifiers

NCT05690516

536544

Details and patient eligibility

About

In this trial the researchers plan to recruit 4,000 volunteers to be randomly allocated either wearing face masks in public spaces where they are close to other people, or not wear face masks in such circumstances. For each participant the trial period is 2 weeks, after which they will be asked to complete a brief questionnaire which includes questions about whether they experienced the common cold, influenzas or COVID-19 symptoms during the trail period.

Full description

This study is a pragmatic, two-armed cluster randomized superiority trial including participants in Norway. Participants will be randomized to one of the following two arms: control group or medical masks in a 1:1 ratio. The primary outcome is self-reported respiratory infection.

The intervention is to ask participants in the intervention groups to wear face masks when close to others outside their home, e.g., in public spaces like shopping centres, and streets and on public transport. The control group will be asked not to wear face masks when close to others outside their home, e.g., in public spaces like shopping centres, and streets and on public transport. Participants will continue to use, or not use, face masks at work independent of which group they are allocated to.

The trial will be fully remote and without any personal interaction between investigators and participants.

The researchers aim to include about 4,000 participants to have a statistical power of 80% to detect a relative risk reduction of 30% for the primary outcome.

Enrollment: 4,575 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Are at least 18 years of age
• Are willing to be randomized to wear, or not to wear, face masks outside their home when close to others for a 14-day period
• Provide informed consent

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,575 participants in 2 patient groups

Face masks

Experimental group

Description:

Participants in the experimental arm are asked to wear face masks when close to others outside their home, e.g., in public spaces like shopping centres, and streets and on public transport.

Treatment:

Behavioral: Wearing face masks

Not face masks

No Intervention group

Description:

Participants in the no intervention arm arm are asked not to wear face masks when close to others outside their home, e.g., in public spaces like shopping centres, and streets and on public transport.