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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04471766
Enrollment
40000
Registered
2020-07-15
Start date
2020-07-20
Completion date
2021-10-31
Last updated
2021-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Respiratory Illness

Keywords

Face mask, COVID-19, Respiratory illness, Mortality

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.

Interventions

OTHERCertified 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

BEHAVIORALPreventive information

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Household resident * Age: 10 years and older

Exclusion criteria

* Refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Reported COVID-like illnessFour months follow-upSelf-reported main symptoms of COVID-19 (three or more - fever, cough, fatigue, shortness of breath, loss of smell / taste)
ConsultationFour months follow-upConsultation for COVID-19 like illness or/and reported positive test
Severe illnessFour months follow-upSelf reported COVID-19 like illness plus hospitalization or death
MortalityFour months follow-upAny death during the follow-up period

Countries

Guinea-Bissau

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026