Acute Respiratory InfectionPhase 2REMASKNCT06885229
Reusable Face Masks to Reduce Risk of Viral Respiratory Infections and Asthma Exacerbations
A Phase 2 study testing FloMask - reuseable face mask in people with Acute Respiratory Infection and Asthma Exacerbations, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
REMASK trial is a Trial within Cohort study (TwiCs), nested within the COVIDENCE UK longitudinal study. It has been designed to determine whether the offer of a free reusable, elastomeric face mask to adults with asthma and other members of their household reduces risk of RT-PCR confirmed viral respiratory infections… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Infection, Asthma Exacerbations
- What is being tested?
- FloMask - reuseable face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Mar 2025to 1 Apr 2025
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aged 16 or more years
- Doctor diagnosis of asthma
- Current prescription for treatment of asthma
- Participant in COVIDENCE UK nasal swab study
- Age 16 or more
- Living in same household as index participant who has consented to take part in trial
Who cannot join
- Regularly using any FFP-rated face mask when in an indoor public place
- Currently sharing household with one or more children
- Currently sharing household with one or more other COVIDENCE UK participants who have asthma
- Unable to tolerate wearing face mask
- Eligibility criteria, household members of index participants:
- Unable to tolerate wearing face mask
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Mary University of London
London, Greater London
About this study
Official title: Reuseable Face Masks to Reduce Risk of Viral Respiratory Infections and Exacerbations in Adults With Asthma: a Randomised Controlled Trial
REMASK trial is a Trial within Cohort study (TwiCs), nested within the COVIDENCE UK longitudinal study. It has been designed to determine whether the offer of a free reusable, elastomeric face mask to adults with asthma and other members of their household reduces risk of RT-PCR confirmed viral respiratory infections and asthma exacerbations.
- Conditions
- Acute Respiratory Infection, Asthma Exacerbations
- Being tested
- FloMask - reuseable face mask
- Keywords
- Upper Respiratory Infection, Acute Respiratory Infection, Asthma Exacerbation, Lower Respiratory Infection, Reusable Face Mask
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloMask - reuseable face maskDevice
Reuseable, elastomeric face mask with replaceable filters
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Offer of free reusable elastometic face mask and 12-month supply of replaceable filters to index participants with asthma and their adult household members Receives: Device: FloMask - reuseable face mask |
| Control | No intervention | Usual asthma care without offer of intervention above |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first RT-PCR-proven viral respiratory infection
Measured: 12 months
Secondary outcomes (6)
Time to first severe acute exacerbation of asthma (i.e. exacerbation requiring treatment with systemic corticosteroids and/or hospitalisation or emergency department visit)
Measured: 12 months
Time to first hospitalisation for treatment of acute respiratory infection or asthma exacerbation
Measured: 12 months
Time to first antibiotic prescription for treatment of acute respiratory infection
Measured: 12 months
Rate of RT-PCR-proven / symptom defined acute respiratory infections
Measured: 12 months
Cost per viral respiratory infection averted
Measured: 12 months
Cost per severe asthma exacerbation averted
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start27 Mar 2025
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Why it stopped: Diminished minimum sample size needed to detect any effect of the intervention due to TwiCs study design, control arm participants were already recruited to the parent study (COVIDENCE UK).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885229
- Sponsor's protocol ID
- 176722
- Other IDs
- 352721
- Acronym
- REMASK
- Status last verified
- May 2025
- First submitted
- 18 Mar 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reuseable Face Masks to Reduce Risk of Viral Respiratory Infections and Exacerbations in Adults With Asthma: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06885229
- Acronym / sponsor ID
- REMASK / 176722
- Conditions
- Acute Respiratory Infection, Asthma Exacerbations
- Keywords
- Upper Respiratory Infection, Acute Respiratory Infection, Asthma Exacerbation, Lower Respiratory Infection, Reusable Face Mask
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Diminished minimum sample size needed to detect any effect of the intervention due to TwiCs study design, control arm participants were already recruited to the parent study (COVIDENCE UK).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 20 Mar 2025 (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.
REMASK trial is a Trial within Cohort study (TwiCs), nested within the COVIDENCE UK longitudinal study. It has been designed to determine whether the offer of a free reusable, elastomeric face mask to adults with asthma and other members of their household reduces risk of RT-PCR confirmed viral respiratory infections and asthma exacerbations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: FloMask - reuseable face maskOffer of free reusable elastometic face mask and 12-month supply of replaceable filters to index participants with asthma and their adult household members |
| Control | No intervention | –Usual asthma care without offer of intervention above |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 16 or more years
- Doctor diagnosis of asthma
- Current prescription for treatment of asthma
- Participant in COVIDENCE UK nasal swab study
- Age 16 or more
Key exclusion criteria (6 listed)
- Regularly using any FFP-rated face mask when in an indoor public place
- Currently sharing household with one or more children
- Currently sharing household with one or more other COVIDENCE UK participants who have asthma
- Unable to tolerate wearing face mask
- Unable to tolerate wearing face mask
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 |
|---|---|---|
| FloMask - reuseable face maskReuseable, elastomeric face mask with replaceable filters | Device | Intervention |
Primary outcome
Time to first RT-PCR-proven viral respiratory infection
Time frame: 12 months
6 secondary outcomes
Time to first severe acute exacerbation of asthma (i.e. exacerbation requiring treatment with systemic corticosteroids and/or hospitalisation or emergency department visit)
Time frame: 12 months
Time to first hospitalisation for treatment of acute respiratory infection or asthma exacerbation
Time frame: 12 months
Time to first antibiotic prescription for treatment of acute respiratory infection
Time frame: 12 months
Rate of RT-PCR-proven / symptom defined acute respiratory infections
Time frame: 12 months
Cost per viral respiratory infection averted
Time frame: 12 months
Cost per severe asthma exacerbation averted
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Yes. De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FloMask - reuseable face mask in people with Acute Respiratory Infection and Asthma Exacerbations, run by Queen Mary University of London at 1 site in United Kingdom.
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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 20 May 2025. 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 United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time to first RT-PCR-proven viral respiratory infection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2025.