NCT04337541

Reduction in COVID-19 Infection Using Surgical Facial Masks Outside the Healthcare System

Completed NA Last updated 3 August 2020

What this trial tests

NA trial testing Surgical facial mask in COVID-19 in 6,000 participants. Completed in 2 June 2020.

Timeline

2 April 2020

Primary endpoint
2 June 2020

2 June 2020

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	6,000
Start date	2 April 2020
Primary completion	2 June 2020
Estimated completion	2 June 2020
Sites	1 location across Denmark

Drugs / interventions tested

• Surgical facial mask

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Rigshospitalet, Denmark

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In the current COVID-19 pandemic with coronavirus, SARS-COV2, the Danish Health Authorities recommend using facial masks in the health care system when handling patients presumed or proven to be infected with the virus. However, the use of facial masks outside the health care system is not recommended by the Danish Health Authorities. Here, Health Authorities in other countries have different recommendations for the use of facial masks.

Challenges when using facial masks outside the health care system include wearing the mask consistently, an efficacy of the mask of app. 8 hours necessitating a change of mask throughout the day, and that it is not sufficiently tight enough to safely keep the virus out. Moreover, the eyes (mucous membrane) remain exposed. Compliance could also be another challenge.

SARS-COV2 is assumed to primarily enter the body via the mouth through respiratory droplets - or possibly through inhalation of aerosol containing the virus. From the mouth the virus is assumed to spread to the airways and the gastro-intestinal tract. SARS-COV2 is also known to be transmitted via physical contact, helped along by the fact that the virus can survive on surfaces for at least 72 hours. Touching such a contaminated surface can transfer the virus to the mouth via the hand - and thus lead to infection of the person.

Facial masks are expected to protect against viral infection in two ways;

1. By reducing the risk of getting the virus in via the mouth or nose via respiratory droplets or aerosol
2. By reducing the transfer from virus-contaminated hands to the mouth or nose

Hypothesis The use of surgical facial masks outside the hospital will reduce the frequency of COVID-19 infection.

All participants will follow authority recommendations and be randomized to either wear facial masks or not. The participants will be screened for antibodies at study start and study end. They will perform swab-test if they experience symptoms during the study as well as the end of study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis.
   Chu DK, Akl EA, Duda S, Solo K, et al · · 2020 · cited 2415× · PMID 32497510 · DOI 10.1016/s0140-6736(20)31142-9
2. 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.
   Bundgaard H, Bundgaard JS, Raaschou-Pedersen DET, von Buchwald C, et al · · 2021 · cited 258× · PMID 33205991 · DOI 10.7326/m20-6817
3. Physical interventions to interrupt or reduce the spread of respiratory viruses.
   Jefferson T, Del Mar CB, Dooley L, Ferroni E, et al · · 2020 · cited 184× · PMID 33215698 · DOI 10.1002/14651858.cd006207.pub5
4. Physical interventions to interrupt or reduce the spread of respiratory viruses.
   Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, et al · · 2023 · cited 148× · PMID 36715243 · DOI 10.1002/14651858.cd006207.pub6
5. Use of facemasks during the COVID-19 pandemic.
   Schünemann HJ, Akl EA, Chou R, Chu DK, et al · · 2020 · cited 45× · PMID 32758441 · DOI 10.1016/s2213-2600(20)30352-0
6. Randomized trials on non-pharmaceutical interventions for COVID-19: a scoping review.
   Hirt J, Janiaud P, Hemkens LG. · · 2022 · cited 24× · PMID 35086864 · DOI 10.1136/bmjebm-2021-111825
7. Efficacy of surgical masks or cloth masks in the prevention of viral transmission: Systematic review, meta-analysis, and proposal for future trial.
   Nanda A, Hung I, Kwong A, Man VC, et al · · 2021 · cited 20× · PMID 33565274 · DOI 10.1111/jebm.12424
8. Face masks for the prevention of COVID-19 - Rationale and design of the randomised controlled trial DANMASK-19.
   Bundgaard H, Bundgaard JS, Raaschou-Pedersen DET, Mariager AF, et al · · 2020 · cited 10× · PMID 32829745