The Protective Effect of Mask Wearing Against Respiratory Tract Infections

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05690516
• Other study ID #: 536544
• Status: Completed
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: May 1, 2023

Study information

• Verified date: January 2023
• Source: Norwegian Institute of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4575
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Respiratory Tract Infections

Intervention

Behavioral:
• Wearing face masks
Participants are asked to wear face masks in public spaces.

Locations

Country	Name	City	State
Norway	Norwegian Institute of Public Health	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian Institute of Public Health	University of Basel

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory symptoms of the common cold, influenza or COVID-19	Self-report	Day 1 to 17
Secondary	Covid-19 prevalence	Self-report	Day 1 to 17
Secondary	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
Secondary	Health care use for respiratory symptoms	Self-report	Day 1 to 17
Secondary	Health care use for injuries	Self-report	Day 1 to 17
Secondary	Health care use (all causes)	Self-report	Day 1 to 17