COVID-19NCT05690516
The Protective Effect of Mask Wearing Against Respiratory Tract Infections
A study testing Wearing face masks in people with COVID-19 and Respiratory Tract Infections, run by Norwegian Institute of Public Health at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Respiratory Tract Infections
- What is being tested?
- Wearing face masks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,575 participants
- Where
- 1 siteNorway
- Study dates
- 10 Feb 2023to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Protective Effect of Mask Wearing Against Respiratory Tract Infections: a Pragmatic Randomized Trial
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.
Read the 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.
- Conditions
- COVID-19, Respiratory Tract Infections
- Being tested
- Wearing face masks
- Medical subject headings
- COVID-19, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing face masksBehavioural
Participants are asked to wear face masks in public spaces.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory symptoms of the common cold, influenza or COVID-19
Self-report
Measured: Day 1 to 17
Secondary outcomes (5)
Covid-19 prevalence
Self-report
Measured: 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)
Measured: Day 3 to 17 after start of tiral period
Health care use for respiratory symptoms
Self-report
Measured: Day 1 to 17
Health care use for injuries
Self-report
Measured: Day 1 to 17
Health care use (all causes)
Self-report
Measured: Day 1 to 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start10 Feb 2023
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 4,575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- University of Basel
- Responsible party
- Sponsor
- Investigators
- Runar Solberg, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690516
- Sponsor's protocol ID
- 536544
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39048132
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Effect of Mask Wearing Against Respiratory Tract Infections: a Pragmatic Randomized Trial
- ClinicalTrials.gov ID
- NCT05690516
- Acronym / sponsor ID
- 536544
- Conditions
- COVID-19, Respiratory Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,575 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- University of Basel
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Face masks | Experimental | Behavioral: Wearing face masksParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearing face masksParticipants are asked to wear face masks in public spaces. | Behavioural | Face masks |
Primary outcome
Respiratory symptoms of the common cold, influenza or COVID-19
Time frame: Day 1 to 17
Self-report
5 secondary outcomes
Covid-19 prevalence
Time frame: Day 1 to 17
Positive test for SARS-CoV-2
Time frame: Day 3 to 17 after start of tiral period
Health care use for respiratory symptoms
Time frame: Day 1 to 17
Health care use for injuries
Time frame: Day 1 to 17
Health care use (all causes)
Time frame: Day 1 to 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 39048132Solberg 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Runar Solberg, PhD principal investigator
Norwegian Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearing face masks in people with COVID-19 and Respiratory Tract Infections, run by Norwegian Institute of Public Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory symptoms of the common cold, influenza or COVID-19 (time frame: Day 1 to 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05690516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.