The Protective Effect of Mask Wearing Against Respiratory Tract Infections

Not Applicable

Completed

• Conditions: COVID-19; Respiratory Tract Infections
• Interventions: Behavioral: Wearing face masks

• Registration Number: NCT05690516
• Lead Sponsor: Norwegian Institute of Public Health

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-19
• Study Start: 2023-02-10
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4575

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face masks	Wearing face masks	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.

Primary Outcome Measures

Name	Time	Method
Respiratory symptoms of the common cold, influenza or COVID-19	Day 1 to 17	Self-report

Secondary Outcome Measures

Name	Time	Method
Positive test for SARS-CoV-2	Day 3 to 17 after start of tiral period	We will compare the incidence of notified cases of COVID-19 (i.e. registered positive SARS-CoV-tests)
Covid-19 prevalence	Day 1 to 17	Self-report
Health care use for injuries	Day 1 to 17	Self-report
Health care use for respiratory symptoms	Day 1 to 17	Self-report
Health care use (all causes)	Day 1 to 17	Self-report

Trial Locations

Locations (1)

Norwegian Institute of Public Health; 🇳🇴 Oslo, Norway