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

Bandim Health Project

Status: Unknown

Conditions: COVID-19; Respiratory Illness

Treatments: Behavioral: Preventive information; Other: Certified cloth face mask plus preventive information

Study type: Interventional

Funder types: Other

Identifiers

NCT04471766

BHP MASK01

Details and patient eligibility

About

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.

Enrollment: 40,000 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Household resident
• Age: 10 years and older

Exclusion criteria

• Refusal to participate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40,000 participants in 2 patient groups

Certified cloth face mask plus preventive information

Experimental group

Description:

Certified cloth face mask

Treatment:

Behavioral: Preventive information

Other: Certified cloth face mask plus preventive information

Information on COVID-19 prevention

Active Comparator group

Description:

Advice on how to prevent COVID-19 according to the government´ policy.

Treatment:

Behavioral: Preventive information