The Protective Effect of Mask Wearing Against Respiratory Tract Infections

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; COVID-19
• Intervention / Treatment: Behavioral: Wearing face masks

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 Type: Interventional
• Enrollment (Actual): 4575
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Runar Solberg, PhD; Phone Number: +4790979648; Email: Runar.Solberg@fhi.no
• Study Contact Backup: Name: Atle Fretheim, PhD; Email: Atle.Fretheim@fhi.no

Study Locations

• Norway
  • Oslo, Norway, 0213
    • Norwegian Institute of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Wearing face masks; Participants are asked to wear face masks in public spaces.
No Intervention: Not face masks; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory symptoms of the common cold, influenza or COVID-19	Self-report	Day 1 to 17

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Norwegian Institute of Public Health
• Collaborators: University of Basel
• Investigators: Principal Investigator: Runar Solberg, PhD, Norwegian Institute of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 536544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The researchers intend to give full access to the protocol, participant level-data dataset and statistical code to anyone who is interested, after securing that the dataset is fully anonymized.
• IPD Sharing Time Frame: The investigators expect to be able to share unidentifiable dataset with partners inside the European Union (EU) by May 2023, and an anonymous dataset for wide distribution at a later stage.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No