NCT05690516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,575

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

February 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

November 29, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

January 11, 2023

Last Update Submit

November 28, 2023

Conditions

COVID-19Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

  • Respiratory symptoms of the common cold, influenza or COVID-19

    Self-report

    Day 1 to 17

Secondary Outcomes (5)

  • Covid-19 prevalence

    Day 1 to 17

  • Positive test for SARS-CoV-2

    Day 3 to 17 after start of tiral period

  • Health care use for respiratory symptoms

    Day 1 to 17

  • Health care use for injuries

    Day 1 to 17

  • Health care use (all causes)

    Day 1 to 17

Study Arms (2)

Face masks

EXPERIMENTAL

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

Not face masks

NO INTERVENTION

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.

Interventions

Wearing face masksBEHAVIORAL

Participants are asked to wear face masks in public spaces.

Face masks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Institute of Public Health

Oslo, 0213, Norway

Location

Related Publications (1)

  • 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.

    PMID: 39048132DERIVED

MeSH Terms

Conditions

COVID-19Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Runar Solberg, PhD

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 19, 2023

Study Start

February 10, 2023

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

November 29, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
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.

Locations

NO(1)