COVID-19NCT04471766
Locally Produced Cloth Face Mask and COVID-19 Like Illness Prevention
A study testing Certified cloth face mask plus preventive information and Preventive information in people with COVID-19 and Respiratory Illness, run by Bandim Health Project at 1 site in Guinea-Bissau.
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- COVID-19, Respiratory Illness
- What is being tested?
- Certified cloth face mask plus preventive information and Preventive information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,000 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- 20 Jul 2020to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Household resident
- Age: 10 years and older
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Locally Produced Cloth Face Mask on COVID-19 and Respiratory Illnesses Prevention at the Community Level - a Cluster-randomized Trial
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.
- Conditions
- COVID-19, Respiratory Illness
- Being tested
- Certified cloth face mask plus preventive information, Preventive information
- Keywords
- Face mask, COVID-19, Respiratory illness, Mortality
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certified cloth face mask plus preventive informationOther
Provision of two face masks sewed locally following a certified model tested for FORCE in the laboratory per residents > 10 years old
Preventive informationBehavioural
Advice on how to prevent COVID-19 according to the government´ policy
| Study group | Role | What they receive |
|---|---|---|
| Certified cloth face mask plus preventive information | Experimental | Certified cloth face mask Receives: Other: Certified cloth face mask plus preventive information; Behavioral: Preventive information |
| Information on COVID-19 prevention | Active comparator | Advice on how to prevent COVID-19 according to the government´ policy. Receives: Behavioral: Preventive information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported COVID-like illness
Self-reported main symptoms of COVID-19 (three or more - fever, cough, fatigue, shortness of breath, loss of smell / taste)
Measured: Four months follow-up
Consultation
Consultation for COVID-19 like illness or/and reported positive test
Measured: Four months follow-up
Severe illness
Self reported COVID-19 like illness plus hospitalization or death
Measured: Four months follow-up
Mortality
Any death during the follow-up period
Measured: Four months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start20 Jul 2020
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Engineers without Borders, Denmark (https://iug.dk/en)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471766
- Sponsor's protocol ID
- BHP MASK01
- Status last verified
- Mar 2021
- First submitted
- 14 Jul 2020
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38349910
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Locally Produced Cloth Face Mask on COVID-19 and Respiratory Illnesses Prevention at the Community Level - a Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT04471766
- Acronym / sponsor ID
- BHP MASK01
- Conditions
- COVID-19, Respiratory Illness
- Keywords
- Face mask, COVID-19, Respiratory illness, Mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Engineers without Borders, Denmark (https://iug.dk/en)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Certified cloth face mask plus preventive information | Experimental | Other: Certified cloth face mask plus preventive information, Behavioral: Preventive informationCertified cloth face mask |
| Information on COVID-19 prevention | Active comparator | Behavioral: Preventive informationAdvice on how to prevent COVID-19 according to the government´ policy. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Household resident
- Age: 10 years and older
Key exclusion criteria (1 listed)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certified cloth face mask plus preventive informationProvision of two face masks sewed locally following a certified model tested for FORCE in the laboratory per residents > 10 years old | Other | Certified cloth face mask plus preventive information |
| Preventive informationAdvice on how to prevent COVID-19 according to the government´ policy | Behavioural | Certified cloth face mask plus preventive information, Information on COVID-19 prevention |
Primary outcome
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)
Consultation
Time frame: Four months follow-up
Consultation for COVID-19 like illness or/and reported positive test
Severe illness
Time frame: Four months follow-up
Self reported COVID-19 like illness plus hospitalization or death
Mortality
Time frame: Four months follow-up
Any death during the follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Derived from this study: PubMed 38349910Nanque 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Certified cloth face mask plus preventive information and Preventive information in people with COVID-19 and Respiratory Illness, run by Bandim Health Project at 1 site in Guinea-Bissau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reported COVID-like illness (time frame: Four months follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04471766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.