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Face masks for the prevention of COVID-19 - Rationale and design of the randomised controlled trial DANMASK-19

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@article{ddb06608ee754dceb144b7bd0f81cef7,
title = "Face masks for the prevention of COVID-19 - Rationale and design of the randomised controlled trial DANMASK-19",
abstract = "INTRODUCTION: The coronavirus disease 19 (COVID-19) pandemic, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), progresses globally, and means to reduce the transmission are needed. In the community, the use of face masks is increasing world-wide, but documentation for the efficacy of this remedy is lacking. This trial investigates whether the use of face masks in the community will reduce wearers' risk of SARS-CoV-2 infection.METHODS: This study will be a two-arm, unblinded, randomised controlled trial. We will include adults (>18 years of age) without prior confirmed COVID-19 or symptoms suggestive of COVID-19, who spend more than three hours per day outside the home with exposure to other people. A total of 6,000 participants are randomly assigned 1:1 to use face masks or not for a 30-day period during the pandemic. Participants will perform self-testing; quick test for SARS-CoV-2 antibodies (immunoglobulin M (IgM) and immunoglobulin G (IgG)) (the Livzon lateral flow test) and oropharyngeal/nasal swabs for viral detection using polymerase chain reaction (PCR). The primary endpoint following the 30-day study period is the difference in the number of SARS-CoV-2-infected individuals between the two study groups as assessed by a positive nasopharyngeal swap, a positive antibody test or a hospital-based diagnosis of SARS-CoV-2 infection.CONCLUSIONS: We will study whether a face mask protects the wearer of the mask against SARS-CoV-2 infection. The findings are expected to apply to the present pandemic and to future viral outbreaks and to provide evidence for authority recommendations across the world.FUNDING: This study was funded by Salling Fondene.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04337541.",
keywords = "Adult, Aged, Communicable Disease Control/methods, Coronavirus Infections/prevention & control, Denmark, Female, Humans, Incidence, Infectious Disease Transmission, Vertical/prevention & control, Male, Masks/statistics & numerical data, Middle Aged, Pandemics/prevention & control, Pneumonia, Viral/prevention & control, Primary Prevention/instrumentation, Public Health, Risk Assessment, World Health Organization",
author = "Henning Bundgaard and Bundgaard, {Johan Skov} and Raaschou-Pedersen, {Daniel Emil Tadeusz} and Mariager, {Anton Friis} and Natasja Schytte and {von Buchwald}, Christian and Tobias Todsen and Kerstin Skovgaard and Romona Trebbien and Andersen, {Mikkel Porsborg} and Thomas Benfield and Henrik Ullum and Christian Torp-Pedersen and Kasper Iversen",
note = "Articles published in the DMJ are “open access”. This means that the articles are distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits any non-commercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.",
year = "2020",
month = "8",
day = "18",
language = "English",
volume = "67",
pages = "A05200363",
journal = "Danish Medical Bulletin (Online)",
issn = "1603-9629",
publisher = "Almindelige Danske Laegeforening",
number = "9",

}

RIS

TY - JOUR

T1 - Face masks for the prevention of COVID-19 - Rationale and design of the randomised controlled trial DANMASK-19

AU - Bundgaard, Henning

AU - Bundgaard, Johan Skov

AU - Raaschou-Pedersen, Daniel Emil Tadeusz

AU - Mariager, Anton Friis

AU - Schytte, Natasja

AU - von Buchwald, Christian

AU - Todsen, Tobias

AU - Skovgaard, Kerstin

AU - Trebbien, Romona

AU - Andersen, Mikkel Porsborg

AU - Benfield, Thomas

AU - Ullum, Henrik

AU - Torp-Pedersen, Christian

AU - Iversen, Kasper

N1 - Articles published in the DMJ are “open access”. This means that the articles are distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits any non-commercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.

PY - 2020/8/18

Y1 - 2020/8/18

N2 - INTRODUCTION: The coronavirus disease 19 (COVID-19) pandemic, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), progresses globally, and means to reduce the transmission are needed. In the community, the use of face masks is increasing world-wide, but documentation for the efficacy of this remedy is lacking. This trial investigates whether the use of face masks in the community will reduce wearers' risk of SARS-CoV-2 infection.METHODS: This study will be a two-arm, unblinded, randomised controlled trial. We will include adults (>18 years of age) without prior confirmed COVID-19 or symptoms suggestive of COVID-19, who spend more than three hours per day outside the home with exposure to other people. A total of 6,000 participants are randomly assigned 1:1 to use face masks or not for a 30-day period during the pandemic. Participants will perform self-testing; quick test for SARS-CoV-2 antibodies (immunoglobulin M (IgM) and immunoglobulin G (IgG)) (the Livzon lateral flow test) and oropharyngeal/nasal swabs for viral detection using polymerase chain reaction (PCR). The primary endpoint following the 30-day study period is the difference in the number of SARS-CoV-2-infected individuals between the two study groups as assessed by a positive nasopharyngeal swap, a positive antibody test or a hospital-based diagnosis of SARS-CoV-2 infection.CONCLUSIONS: We will study whether a face mask protects the wearer of the mask against SARS-CoV-2 infection. The findings are expected to apply to the present pandemic and to future viral outbreaks and to provide evidence for authority recommendations across the world.FUNDING: This study was funded by Salling Fondene.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04337541.

AB - INTRODUCTION: The coronavirus disease 19 (COVID-19) pandemic, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), progresses globally, and means to reduce the transmission are needed. In the community, the use of face masks is increasing world-wide, but documentation for the efficacy of this remedy is lacking. This trial investigates whether the use of face masks in the community will reduce wearers' risk of SARS-CoV-2 infection.METHODS: This study will be a two-arm, unblinded, randomised controlled trial. We will include adults (>18 years of age) without prior confirmed COVID-19 or symptoms suggestive of COVID-19, who spend more than three hours per day outside the home with exposure to other people. A total of 6,000 participants are randomly assigned 1:1 to use face masks or not for a 30-day period during the pandemic. Participants will perform self-testing; quick test for SARS-CoV-2 antibodies (immunoglobulin M (IgM) and immunoglobulin G (IgG)) (the Livzon lateral flow test) and oropharyngeal/nasal swabs for viral detection using polymerase chain reaction (PCR). The primary endpoint following the 30-day study period is the difference in the number of SARS-CoV-2-infected individuals between the two study groups as assessed by a positive nasopharyngeal swap, a positive antibody test or a hospital-based diagnosis of SARS-CoV-2 infection.CONCLUSIONS: We will study whether a face mask protects the wearer of the mask against SARS-CoV-2 infection. The findings are expected to apply to the present pandemic and to future viral outbreaks and to provide evidence for authority recommendations across the world.FUNDING: This study was funded by Salling Fondene.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04337541.

KW - Adult

KW - Aged

KW - Communicable Disease Control/methods

KW - Coronavirus Infections/prevention & control

KW - Denmark

KW - Female

KW - Humans

KW - Incidence

KW - Infectious Disease Transmission, Vertical/prevention & control

KW - Male

KW - Masks/statistics & numerical data

KW - Middle Aged

KW - Pandemics/prevention & control

KW - Pneumonia, Viral/prevention & control

KW - Primary Prevention/instrumentation

KW - Public Health

KW - Risk Assessment

KW - World Health Organization

M3 - Journal article

VL - 67

SP - A05200363

JO - Danish Medical Bulletin (Online)

JF - Danish Medical Bulletin (Online)

SN - 1603-9629

IS - 9

ER -

ID: 60888464