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The Protective Effect of Mask Wearing Against Respiratory Tract Infections

NCT ID: NCT05690516

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4575 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-10

Study Completion Date

2023-05-01

Brief Summary

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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

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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.

Conditions

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COVID-19 Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Wearing face masks

Intervention Type BEHAVIORAL

Participants are asked to wear face masks in public spaces.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Wearing face masks

Participants are asked to wear face masks in public spaces.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Basel

OTHER

Sponsor Role collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Runar Solberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian Institute of Public Health

Locations

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Norwegian Institute of Public Health

Oslo, , Norway

Site Status

Countries

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Norway

References

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Solberg RB, Fretheim A, Elgersma IH, Fagernes M, Iversen BG, Hemkens LG, Rose CJ, Elstrom P. Personal protective effect of wearing surgical face masks in public spaces on self-reported respiratory symptoms in adults: pragmatic randomised superiority trial. BMJ. 2024 Jul 24;386:e078918. doi: 10.1136/bmj-2023-078918.

Reference Type DERIVED
PMID: 39048132 (View on PubMed)

Other Identifiers

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536544

Identifier Type: -

Identifier Source: org_study_id