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

Phase 2

Withdrawn

• Conditions: Acute Respiratory Infection; Asthma Exacerbations

• Registration Number: NCT06885229
• Lead Sponsor: Queen Mary University of London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-20
• Study Start: 2025-03-27
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 290

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to first RT-PCR-proven viral respiratory infection	12 months

Secondary Outcome Measures

Name	Time	Method
Rate of RT-PCR-proven / symptom defined acute respiratory infections	12 months
Cost per severe asthma exacerbation averted	12 months
Time to first severe acute exacerbation of asthma (i.e. exacerbation requiring treatment with systemic corticosteroids and/or hospitalisation or emergency department visit)	12 months
Time to first hospitalisation for treatment of acute respiratory infection or asthma exacerbation	12 months
Time to first antibiotic prescription for treatment of acute respiratory infection	12 months
Cost per viral respiratory infection averted	12 months

Trial Locations

Locations (1)

Queen Mary University of London; 🇬🇧 London, Greater London, United Kingdom