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WithdrawnNCT06885229REMASKUpdated May 20, 2025

Reusable Face Masks to Reduce Risk of Viral Respiratory Infections and Asthma Exacerbations

A Phase 2 interventional study of FloMask - reuseable face mask in Acute Respiratory Infection and Asthma Exacerbations, sponsored by Queen Mary University of London. Withdrawn at 1 site in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-20.

Sponsored by Queen Mary University of London · Phase 2, Interventional, and Prevention

Why this study was withdrawn
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).
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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 and asthma exacerbations.

02

Conditions studied

  • Acute Respiratory Infection
  • Asthma Exacerbations

Keywords

  • Upper Respiratory Infection
  • Acute Respiratory Infection
  • Asthma Exacerbation
  • Lower Respiratory Infection
  • Reusable Face Mask
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

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Lead sponsor

Queen Mary University of London is the lead sponsor of 250 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Eligibility criteria, participants with asthma ('index participants'):

Inclusion Criteria:

  • Aged 16 or more years
  • Doctor diagnosis of asthma
  • Current prescription for treatment of asthma
  • Participant in COVIDENCE UK nasal swab study

Exclusion Criteria:

  • 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:

Inclusion criteria

  • Age 16 or more
  • Living in same household as index participant who has consented to take part in trial

Exclusion criteria

  • Unable to tolerate wearing face mask
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Intervention

    Offer of free reusable elastometic face mask and 12-month supply of replaceable filters to index participants with asthma and their adult household members

    Device: FloMask - reuseable face mask

  • No intervention
    Control

    Usual asthma care without offer of intervention above

Interventions

  • DeviceFloMask - reuseable face mask

    Reuseable, elastomeric face mask with replaceable filters

06

What researchers measure

Primary outcomes

  1. Time to first RT-PCR-proven viral respiratory infection

    Time frame: 12 months

Secondary outcomes

  1. 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

  2. Time to first hospitalisation for treatment of acute respiratory infection or asthma exacerbation

    Time frame: 12 months

  3. Time to first antibiotic prescription for treatment of acute respiratory infection

    Time frame: 12 months

  4. Rate of RT-PCR-proven / symptom defined acute respiratory infections

    Time frame: 12 months

  5. Cost per viral respiratory infection averted

    Time frame: 12 months

  6. Cost per severe asthma exacerbation averted

    Time frame: 12 months

07

Study locations

1 site
  • Queen Mary University of London
    London, Greater London, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06885229
Lead sponsor
Queen Mary University of London
Responsible party
Sponsor
First posted
Mar 20, 2025
Start date
Mar 27, 2025
Primary completion
Apr 1, 2025
Completion
Apr 1, 2025
Last update
May 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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