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

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. 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.

Conditions

• COVID-19

Interventions

OTHER

Surgical facial mask

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

Sponsors & Collaborators

• Nordsjaellands Hospital

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Technical University of Denmark

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Henrik Ullum, Prof., DMSc · Rigshospitalet, Denmark

• Kasper Karmark Iversen, Prof., DMSc · Herlev Hospital

• Thomas Benfield, Prof., DMSc · Hvidovre University Hospital

• Christian Torp-Pedersen, Prof., DMSc · Nordsjaellands Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-04-02

Primary Completion

2020-06-02

Completion

2020-06-02

Countries

• Denmark

Study Locations