DANMASK-19
Trial question
What is the effect of adding a mask recommendation to other public health measures to prevent SARS-CoV-2 infection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 6024
6024 patients (3116 female, 2908 male)
Inclusion criteria: adults spending > 3 hours/day outside the home without occupational mask use
Key exclusion criteria: previously tested positive for corona-virus, wearing facial mask for work
Interventions
N=2392 face mask (mask wearers)
N=2470 control (non-mask wearers)
Primary outcome
Severe acute respiratory syndrome coronavirus 2 infection at 1 month
1.8
2.1
2.1 %
1.6 %
1.1 %
0.5 %
0.0 %
Face
mask
Control
No significant
difference ↔
No significant difference in SARS-CoV-2 infection at 1 month (1.8% vs. 2.1%; OR 0.82, 95% CI 0.54 to 1.23)
Secondary outcomes
No significant difference in PCR positivity for other respiratory viruses (0.5% vs. 0.6%; OR 0.84, 95% CI 0.35 to 2.04)
No significant difference in positivity for any virus including SARS-CoV-2 infection (0.5% vs. 0.8%; OR 0.58, 95% CI 0.25 to 1.31)
No significant difference in health care-diagnosed COVID-19 (0.2% vs. 0.4%; OR 0.52, 95% CI 0.18 to 1.53)
Conclusion
In adults spending > 3 hours/day outside the home without occupational mask use, face mask was not superior to control with respect to SARS-CoV-2 infection at 1 month.
Reference
Henning Bundgaard, Johan Skov Bundgaard, Daniel Emil Tadeusz Raaschou-Pedersen et al. Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers : A Randomized Controlled Trial. Ann Intern Med. 2021 Mar;174(3):335-343.
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