Face masks for the prevention of COVID-19 - Rationale and design of the randomised controlled trial DANMASK-19.
Dan Med J
; 67(9)2020 Aug 18.
Article
in English
| MEDLINE | ID: covidwho-979304
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 11 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.
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Collection:
International databases
Database:
MEDLINE
Main subject:
Pneumonia, Viral
/
Communicable Disease Control
/
Public Health
/
Coronavirus Infections
/
Infectious Disease Transmission, Vertical
/
Pandemics
/
Masks
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
Europa
Language:
English
Year:
2020
Document Type:
Article
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