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

May 15, 2025 updated by: Queen Mary University of London

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom
        • Queen Mary University of London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Reuseable, elastomeric face mask with replaceable filters
No Intervention: Control
Usual asthma care without offer of intervention above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first RT-PCR-proven viral respiratory infection
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months
Time to first hospitalisation for treatment of acute respiratory infection or asthma exacerbation
Time Frame: 12 months
12 months
Time to first antibiotic prescription for treatment of acute respiratory infection
Time Frame: 12 months
12 months
Rate of RT-PCR-proven / symptom defined acute respiratory infections
Time Frame: 12 months
12 months
Cost per viral respiratory infection averted
Time Frame: 12 months
12 months
Cost per severe asthma exacerbation averted
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2025

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 176722
  • 352721 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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