Clinical trial NCT05690516: The Protective Effect of Mask Wearing Against Respiratory Tract Infections
Official title: The Protective Effect of Mask Wearing Against Respiratory Tract Infections: a Pragmatic Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Respiratory Tract Infections
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: University of Basel
First posted: 2023-01-19
Enrollment: 4575
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory symptoms of the common cold, influenza or COVID-19
timeFrame: Day 1 to 17
Secondary outcomes:
measure: Covid-19 prevalence
timeFrame: Day 1 to 17
measure: Positive test for SARS-CoV-2
timeFrame: Day 3 to 17 after start of tiral period
measure: Health care use for respiratory symptoms
timeFrame: Day 1 to 17
measure: Health care use for injuries
timeFrame: Day 1 to 17
measure: Health care use (all causes)
timeFrame: Day 1 to 17
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian Institute of Public Health
Study officials:
affiliation: Norwegian Institute of Public Health
name: Runar Solberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: