The Protective Effect of Mask Wearing Against Respiratory Tract Infections

• Sponsor: Norwegian Institute of Public Health (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05690516
• Collaborator: University of Basel (Other)
• Enrollment: 4,000
• Arms: 2
• Anticipated Duration (Months): 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Respiratory Tract Infections	Behavioral: Wearing face masks	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 4000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Protective Effect of Mask Wearing Against Respiratory Tract Infections: a Pragmatic Randomized Trial
• Anticipated Study Start Date: Feb 2, 2023
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Respiratory symptoms of the common cold, influenza or COVID-19 [Day 1 to 17]

   Self-report

Secondary Outcome Measures

1. Covid-19 prevalence [Day 1 to 17]

   Self-report

2. 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)

3. Health care use for respiratory symptoms [Day 1 to 17]

   Self-report

4. Health care use for injuries [Day 1 to 17]

   Self-report

5. Health care use (all causes) [Day 1 to 17]

   Self-report

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Norwegian Institute of Public Health
• University of Basel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian Institute of Public Health
• ClinicalTrials.gov Identifier: NCT05690516
• Other Study ID Numbers: 536544
• First Posted: Jan 19, 2023
• Last Update Posted: Jan 31, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections

Study Results

No Results Posted as of Jan 31, 2023