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

NCT04337541 | Completed

• 1 other identifier: 2020-04-02
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3:

  Component 1 of primary endpoint: Positive oropharyngeal/nasal swab with SARS-CoV-2 (PCR) and/or

  1 month

• The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3:

  Component 2 of primary endpoint: Antibody test; Development of positive SARS-CoV-2 antibody test (IgM and/or IgG) during the study period and/or

  1 month

• The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3:

  Component 3 of primary endpoint: SARS-CoV-2 infection diagnosed in a hospital/health care facility

  1 month

Secondary Outcomes (2)

• Positive oropharyngeal/nasal swab (PCR);

  1 month

• Positive oropharyngeal/nasal swab (PCR);

  1 month

Other Outcomes (12)

• Difference between the two study groups

  1 month

• Discribtion of the face mask users psycological aspects of wearing face masks

  1 month

• Costs associated with wearing vs not wearing face masks

  1 month

Study Arms (2)

Normal recommendations, no mask

NO INTERVENTION

Normal behavior according to the authority's recommendations or

Normal recommendations AND mask

EXPERIMENTAL

Normal behavior according to the authority's recommendations AND use of facial masks

Other: Surgical facial mask

Interventions

Surgical facial mask OTHER

Participants will follow normal Authority recommendations AND wear mask outside their homes, or when receiving visits in their home.

Normal recommendations AND mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years of age and without symptoms associated with corona-virus (or previously tested positive for corona).
• Participant is outside their home more than 3 hours a day. E.g.for work or for other activities among other people.
• Do not normally wear a facial mask for daily work (e.g. healthcare personnel)

You may not qualify if:

• Previously tested positive for corona-virus
• Wear facial mask for work

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Nordsjaellands Hospital: collaborator
• Hvidovre University Hospital: collaborator
• Herlev Hospital: collaborator
• Technical University of Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (7)

• Feng S, Shen C, Xia N, Song W, Fan M, Cowling BJ. Rational use of face masks in the COVID-19 pandemic. Lancet Respir Med. 2020 May;8(5):434-436. doi: 10.1016/S2213-2600(20)30134-X. Epub 2020 Mar 20. No abstract available.

  PMID: 32203710 BACKGROUND

• van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.

  PMID: 32182409 BACKGROUND

• Kwok YL, Gralton J, McLaws ML. Face touching: a frequent habit that has implications for hand hygiene. Am J Infect Control. 2015 Feb;43(2):112-4. doi: 10.1016/j.ajic.2014.10.015.

  PMID: 25637115 BACKGROUND

• Uchida M, Kaneko M, Hidaka Y, Yamamoto H, Honda T, Takeuchi S, Saito M, Kawa S. Effectiveness of vaccination and wearing masks on seasonal influenza in Matsumoto City, Japan, in the 2014/2015 season: An observational study among all elementary schoolchildren. Prev Med Rep. 2016 Dec 6;5:86-91. doi: 10.1016/j.pmedr.2016.12.002. eCollection 2017 Mar.

  PMID: 27981021 BACKGROUND

• Gralton J, McLaws ML. Protecting healthcare workers from pandemic influenza: N95 or surgical masks? Crit Care Med. 2010 Feb;38(2):657-67. doi: 10.1097/ccm.0b013e3181b9e8b3.

  PMID: 20095070 BACKGROUND

• Bundgaard H, Bundgaard JS, Raaschou-Pedersen DET, von Buchwald C, Todsen T, Norsk JB, Pries-Heje MM, Vissing CR, Nielsen PB, Winslow UC, Fogh K, Hasselbalch R, Kristensen JH, Ringgaard A, Porsborg Andersen M, Goecke NB, Trebbien R, Skovgaard K, Benfield T, Ullum H, Torp-Pedersen C, Iversen K. 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. doi: 10.7326/M20-6817. Epub 2020 Nov 18.

  PMID: 33205991 DERIVED

• Bundgaard H, Bundgaard JS, Raaschou-Pedersen DET, Mariager AF, Schytte N, von Buchwald C, Todsen T, Skovgaard K, Trebbien R, Andersen MP, Benfield T, Ullum H, Torp-Pedersen C, Iversen K. Face masks for the prevention of COVID-19 - Rationale and design of the randomised controlled trial DANMASK-19. Dan Med J. 2020 Aug 18;67(9):A05200363.

  PMID: 32829745 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Henrik Ullum, Prof., DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Kasper Karmark Iversen, Prof., DMSc

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

• Thomas Benfield, Prof., DMSc

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Christian Torp-Pedersen, Prof., DMSc

  Nordsjaellands Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology, Consultant, MD, DMSc

Model Details: The participants recruited are people working outside of their home, who have not previously been infected with COVID-19 and who do not wear facial masks (e.g. healthcare personnel) when working. They will be randomized for 1. Normal behavior according to the authority's recommendations or 2. Normal behavior according to the authority's recommendations and use of facial masks Participants will be instructed in using the facial mask consistently when outside their home (and at home when receiving visits from others. The instruction is given in writing and via an instruction video. The participants will be contacted once weekly to optimize compliance. It will be registered if the participants are diagnosed with COVID-19. Participants will perform antibody screening at study start and end. Participants, who are not tested positive for COVID-19 in the study period will perform a swab self-test if experiencing symptoms or when the study ends (instruction video).

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 7, 2020
• Study Start: April 2, 2020
• Primary Completion: June 2, 2020
• Study Completion: June 2, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)