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The Protective Effect of Mask Wearing Against Respiratory Tract Infections

The Protective Effect of Mask Wearing Against Respiratory Tract Infections: a Pragmatic Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05690516
Enrollment
4575
Registered
2023-01-19
Start date
2023-02-10
Completion date
2023-05-01
Last updated
2023-11-29

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

Conditions

COVID-19, Respiratory Tract Infections

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.

Interventions

BEHAVIORALWearing face masks

Participants are asked to wear face masks in public spaces.

Sponsors

University of Basel
CollaboratorOTHER
Norwegian Institute of Public Health
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Sequence generation. We will use a simple 1:1 randomization by means of computer-generated random numbers. The allocation will be concealed as the participant themselves will be directly informed of their allocation as soon as they have agreed to take part in the trial and have completed the online consent and baseline form. Generation of allocation sequence, enrolment of participants and assignment of participants will all be handled by the digital recruitment platform.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory symptoms of the common cold, influenza or COVID-19Day 1 to 17Self-report

Secondary

MeasureTime frameDescription
Covid-19 prevalenceDay 1 to 17Self-report
Positive test for SARS-CoV-2Day 3 to 17 after start of tiral periodWe will compare the incidence of notified cases of COVID-19 (i.e. registered positive SARS-CoV-tests)
Health care use for respiratory symptomsDay 1 to 17Self-report
Health care use for injuriesDay 1 to 17Self-report
Health care use (all causes)Day 1 to 17Self-report

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026