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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04471766
• Other study ID #: BHP MASK01
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: October 2021

Study information

• Verified date: March 2021
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40000
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Household resident

• Age: 10 years and older

Exclusion Criteria:

• Refusal to participate

Related Conditions & MeSH terms

• COVID-19
• Respiratory Illness

Intervention

Other:
• Certified cloth face mask plus preventive information
Provision of two face masks sewed locally following a certified model tested for FORCE in the laboratory per residents > 10 years old

Behavioral:
• Preventive information
Advice on how to prevent COVID-19 according to the government´ policy

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project	Bissau	Bissau Codex

Sponsors (3)

Lead Sponsor	Collaborator
Bandim Health Project	Engineers without Borders, Denmark (https://iug.dk/en), University of Southern Denmark

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Consultation	Consultation for COVID-19 like illness or/and reported positive test	Four months follow-up
Primary	Severe illness	Self reported COVID-19 like illness plus hospitalization or death	Four months follow-up
Primary	Mortality	Any death during the follow-up period	Four months follow-up