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
C2 - 32829745
SN - 1603-9629
VL - 67
SP - A05200363
JO - Danish Medical Journal
JF - Danish Medical Journal
IS - 9
ER -