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

Queen Mary University of London

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Acute Respiratory Infection Asthma Exacerbations

Interventions

FloMask - reuseable face maskDEVICE

Reuseable, elastomeric face mask with replaceable filters

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Queen Mary University of London

London, Greater London, United Kingdom

Outcomes

Primary Outcomes

Time to first RT-PCR-proven viral respiratory infection

Time frame: 12 months

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

Data from ClinicalTrials.gov

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