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

Queen Mary University of London

Status and phase: Not yet enrolling; Phase 2

Conditions: Acute Respiratory Infection; Asthma Exacerbations

Treatments: Device: FloMask - reuseable face mask

Study type: Interventional

Funder types: Other

Identifiers

NCT06885229

352721 (Other Identifier)

176722

Details and patient eligibility

About

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.

Enrollment: 290 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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290 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Device: FloMask - reuseable face mask

Control

No Intervention group

Description:

Usual asthma care without offer of intervention above