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Clinical Trials/NCT04471766
NCT04471766
Unknown
Not Applicable

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

Bandim Health Project1 site in 1 country40,000 target enrollmentJuly 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Bandim Health Project
Enrollment
40000
Locations
1
Primary Endpoint
Mortality
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2020
End Date
October 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Household resident
  • Age: 10 years and older

Exclusion Criteria

  • Refusal to participate

Outcomes

Primary Outcomes

Mortality

Time Frame: Four months follow-up

Any death during the follow-up period

Reported COVID-like illness

Time Frame: Four months follow-up

Self-reported main symptoms of COVID-19 (three or more - fever, cough, fatigue, shortness of breath, loss of smell / taste)

Consultation

Time Frame: Four months follow-up

Consultation for COVID-19 like illness or/and reported positive test

Severe illness

Time Frame: Four months follow-up

Self reported COVID-19 like illness plus hospitalization or death

Study Sites (1)

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