Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 352721 | Other Identifier | IRAS |
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Offer of free reusable elastometic face mask and 12-month supply of replaceable filters to index participants with asthma and their adult household members |
|
| Control | No Intervention | Usual asthma care without offer of intervention above |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FloMask - reuseable face mask | Device | Reuseable, elastomeric face mask with replaceable filters |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first RT-PCR-proven viral respiratory infection | 12 months |
| Measure | Description | 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) | 12 months | |
| Time to first hospitalisation for treatment of acute respiratory infection or asthma exacerbation |
Not provided
Eligibility criteria, participants with asthma ('index participants'):
Inclusion Criteria:
Exclusion Criteria:
Eligibility criteria, household members of index participants:
Inclusion criteria
Exclusion criteria
- Unable to tolerate wearing face mask
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary University of London | London | Greater London | United Kingdom |
De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months |
| Time to first antibiotic prescription for treatment of acute respiratory infection | 12 months |
| Rate of RT-PCR-proven / symptom defined acute respiratory infections | 12 months |
| Cost per viral respiratory infection averted | 12 months |
| Cost per severe asthma exacerbation averted | 12 months |