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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
| Engineers without Borders, Denmark (https://iug.dk/en) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certified cloth face mask plus preventive information | Experimental | Certified cloth face mask |
|
| Information on COVID-19 prevention | Active Comparator | Advice on how to prevent COVID-19 according to the government´ policy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certified cloth face mask plus preventive information | Other | Provision of two face masks sewed locally following a certified model tested for FORCE in the laboratory per residents > 10 years old |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bandim Health Project | Bissau | Bissau Codex | Guinea-Bissau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38349910 | Derived | Nanque LM, Jensen AM, Diness A, Nielsen S, Cabral C, Cawthorne D, Martins JSD, Ca EJC, Jensen K, Martins CL, Rodrigues A, Fisker AB. Effect of distributing locally produced cloth facemasks on COVID-19-like illness and all-cause mortality-a cluster-randomised controlled trial in urban Guinea-Bissau. PLOS Glob Public Health. 2024 Feb 13;4(2):e0002901. doi: 10.1371/journal.pgph.0002901. eCollection 2024. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 8, 2026 | |
| Reset | Feb 24, 2026 | |
| Release | May 22, 2026 | |
| Reset | Jun 17, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2021 | Sep 21, 2021 | SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 8, 2026 | Feb 24, 2026 | |||
| May 22, 2026 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Preventive information | Behavioral | Advice on how to prevent COVID-19 according to the government´ policy |
|
| Jun 17, 2026 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |