Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Basel | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearing face masks | Behavioral | Participants are asked to wear face masks in public spaces. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory symptoms of the common cold, influenza or COVID-19 | Self-report | Day 1 to 17 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Runar Solberg, PhD | Norwegian Institute of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwegian Institute of Public Health | Oslo | 0213 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39048132 | Derived | 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. |
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D007239 | Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| 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 |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |