• Henning Bundgaard, Johan Skov Bundgaard, Daniel Emil Tadeusz Raaschou-Pedersen, Anton Friis Mariager, Natasja Schytte, Christian von Buchwald, Tobias Todsen, Kerstin Skovgaard, Romona Trebbien, Mikkel Porsborg Andersen, Thomas Benfield, Henrik Ullum, Christian Torp-Pedersen, and Kasper Iversen.
• henning.bundgaard@regionh.dk.
• Dan Med J. 2020 Aug 18; 67 (9).

IntroductionThe 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.MethodsThis 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.ConclusionsWe 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.FundingThis study was funded by Salling Fondene.Trial RegistrationClinicalTrials.gov Identifier: NCT04337541.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.

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