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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04471766
Recruitment Status : Enrolling by invitation
First Posted : July 15, 2020
Last Update Posted : July 22, 2020
Sponsor:
Collaborators:
University of Southern Denmark
Engineers without Borders, Denmark (https://iug.dk/en)
Information provided by (Responsible Party):
Bandim Health Project

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.


Condition or disease Intervention/treatment Phase
COVID-19 Respiratory Illness Other: Certified cloth face mask plus preventive information Behavioral: Preventive information Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Locally Produced Cloth Face Mask on COVID-19 and Respiratory Illnesses Prevention at the Community Level - a Cluster-randomized Trial
Actual Study Start Date : July 20, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: Certified cloth face mask plus preventive information
Certified cloth face mask
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

Active Comparator: Information on COVID-19 prevention
Advice on how to prevent COVID-19 according to the government´ policy.
Behavioral: Preventive information
Advice on how to prevent COVID-19 according to the government´ policy




Primary Outcome Measures :
  1. 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)

  2. Consultation [ Time Frame: Four months follow-up ]
    Consultation for COVID-19 like illness or/and reported positive test

  3. Severe illness [ Time Frame: Four months follow-up ]
    Self reported COVID-19 like illness plus hospitalization or death

  4. Mortality [ Time Frame: Four months follow-up ]
    Any death during the follow-up period



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Household resident
  • Age: 10 years and older

Exclusion Criteria:

  • Refusal to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04471766


Locations
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Guinea-Bissau
Bandim Health Project
Bissau, Bissau Codex, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
University of Southern Denmark
Engineers without Borders, Denmark (https://iug.dk/en)
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Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT04471766    
Other Study ID Numbers: BHP MASK01
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bandim Health Project:
Face mask
COVID-19
Respiratory illness
Mortality