COVID: No Real Differences by Wearing Masks – Largest Randomized Controlled Trial

Nov 20, 2020 by

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“COVID: No Real Differences by Wearing Masks – Largest Randomized Controlled Trial”
by Donna Garner

11.20.20

11.18.20 – ACP Journals

New York Times reported: “About 4,860 participants completed the study. The researchers had hoped that masks would cut the infection rate by half among wearers. Instead, 42 people in the mask group, or 1.8 percent, got infected, compared with 53 in the unmasked group, or 2.1 percent. The difference was not statistically significant.” – 11.18.20 — https://www.nytimes.com/2020/11/18/health/coronavirus-masks-denmark.html

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QUOTES FROM THE SPECTATOR UK — 11.19.20 — https://www.spectator.co.uk/article/do-masks-stop-the-spread-of-covid-19-/amp

Yesterday marked the publication of a long-delayed trial in Denmark which hopes to answer that very question. The ‘Danmask-19 trial’ was conducted in the spring with over 3,000 participants, when the public were not being told to wear masks but other public health measures were in place. Unlike other studies looking at masks, the Danmask study was a randomised controlled trial – making it the highest quality scientific evidence.

Around half of those in the trial received 50 disposable surgical face masks, which they were told to change after eight hours of use. After one month, the trial participants were tested using both PCR, antibody and lateral flow tests and compared with the trial participants who did not wear a mask.

In the end, there was no statistically significant difference between those who wore masks and those who did not when it came to being infected by Covid-19. 1.8 per cent of those wearing masks caught Covid, compared to 2.1 per cent of the control group….

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“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

Henning Bundgaard, DMSc, Johan Skov Bundgaard, BSc

https://www.acpjournals.org/doi/10.7326/M20-6817?_ga=2.41527329.2067389813.1605806905-764236305.1605806904&

Abstract

Background:

Observational evidence suggests that mask wearing mitigates transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is uncertain if this observed association arises through protection of uninfected wearers (protective effect), via reduced transmission from infected mask wearers (source control), or both.

Objective:

To assess whether recommending surgical mask use outside the home reduces wearers’ risk for SARS-CoV-2 infection in a setting where masks were uncommon and not among recommended public health measures.

Design:

Randomized controlled trial (DANMASK-19 [Danish Study to Assess Face Masks for the Protection Against COVID-19 Infection]). (ClinicalTrials.gov: NCT04337541)

Setting:

Denmark, April and May 2020.

Participants:

Adults spending more than 3 hours per day outside the home without occupational mask use.

Intervention:

Encouragement to follow social distancing measures for coronavirus disease 2019, plus either no mask recommendation or a recommendation to wear a mask when outside the home among other persons together with a supply of 50 surgical masks and instructions for proper use.

Measurements:

The primary outcome was SARS-CoV-2 infection in the mask wearer at 1 month by antibody testing, polymerase chain reaction (PCR), or hospital diagnosis. The secondary outcome was PCR positivity for other respiratory viruses.

Results:

A total of 3030 participants were randomly assigned to the recommendation to wear masks, and 2994 were assigned to control; 4862 completed the study. Infection with SARS-CoV-2 occurred in 42 participants recommended masks (1.8%) and 53 control participants (2.1%). The between-group difference was −0.3 percentage point (95% CI, −1.2 to 0.4 percentage point; P = 0.38) (odds ratio, 0.82 [CI, 0.54 to 1.23]; P = 0.33). Multiple imputation accounting for loss to follow-up yielded similar results. Although the difference observed was not statistically significant, the 95% CIs are compatible with a 46% reduction to a 23% increase in infection…

Conclusion:

The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers by more than 50% in a community with modest infection rates, some degree of social distancing, and uncommon general mask use. The data were compatible with lesser degrees of self-protection.

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