Locally Produced Cloth Face Mask and COVID-19 Like Illness Prevention

Study Overview
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Brief Summary
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The number of cases of COVID-19 is still increasing and transmission of SARS-CoV-2 seems to occur mainly through person-to-person transmission through respiratory droplets, indirect contact with infected people and surfaces. The use of face masks is recommended as a public health measure, but in many settings only domestic cloth made masks are available to the majority of the people. However, masks can be of different quality and very little is known about the utility of cloth face masks at the community level. In Bandim Health Project's Health and Demographic Surveillance System we will evaluate the effect of providing locally produced cloth face masks on severity of COVID-19 like illness and mortality in an urban population. The locally produced cloth mask is made according to a laboratory certified model and will be provided to the intervention group alongside information of how the risk of transmission can be reduced. The control group will receive information alone. Follow-up will be implemented through telephone calls and post-epidemic home visits.

Official Title
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Evaluation of Locally Produced Cloth Face Mask on COVID-19 and Respiratory Illnesses Prevention at the Community Level - a Cluster-randomized Trial

Conditions
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COVID-19, Respiratory Illness

Intervention / Treatment
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* Other: Certified cloth face mask plus preventive information
* Behavioral: Preventive information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Household resident Age: 10 years and older Exclusion Criteria: Refusal to participate

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Certified cloth face mask plus preventive information<br>Certified cloth face mask | Other: Certified cloth face mask plus preventive information<br>* Provision of two face masks sewed locally following a certified model tested for FORCE in the laboratory per residents > 10 years old<br>Behavioral: Preventive information<br>* Advice on how to prevent COVID-19 according to the government´ policy<br>|
| Active Comparator: Information on COVID-19 prevention<br>Advice on how to prevent COVID-19 according to the government´ policy. | Behavioral: Preventive information<br>* Advice on how to prevent COVID-19 according to the government´ policy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported COVID-like illness | Self-reported main symptoms of COVID-19 (three or more - fever, cough, fatigue, shortness of breath, loss of smell / taste) | Four months follow-up | 
| Consultation | Consultation for COVID-19 like illness or/and reported positive test | Four months follow-up | 
| Severe illness | Self reported COVID-19 like illness plus hospitalization or death | Four months follow-up | 
| Mortality | Any death during the follow-up period | Four months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Face mask, COVID-19, Respiratory illness, Mortality