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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04337541
Recruitment Status : Completed
First Posted : April 7, 2020
Last Update Posted : August 3, 2020
Sponsor:
Collaborators:
Nordsjaellands Hospital
Hvidovre University Hospital
Herlev Hospital
Technical University of Denmark
Information provided by (Responsible Party):
Henning Bundgaard, Rigshospitalet, Denmark

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. 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.


Condition or disease Intervention/treatment Phase
COVID-19 Other: Surgical facial mask Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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).

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reduction in COVID-19 Infection Using Surgical Facial Masks Outside the Healthcare System
Actual Study Start Date : April 2, 2020
Actual Primary Completion Date : June 2, 2020
Actual Study Completion Date : June 2, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Normal recommendations, no mask
Normal behavior according to the authority's recommendations or
Experimental: Normal recommendations AND mask
Normal behavior according to the authority's recommendations AND use of facial masks
Other: Surgical facial mask
Participants will follow normal Authority recommendations AND wear mask outside their homes, or when receiving visits in their home.




Primary Outcome Measures :
  1. 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: [ Time Frame: 1 month ]
    Component 1 of primary endpoint: Positive oropharyngeal/nasal swab with SARS-CoV-2 (PCR) and/or

  2. 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: [ Time Frame: 1 month ]
    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

  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: [ Time Frame: 1 month ]
    Component 3 of primary endpoint: SARS-CoV-2 infection diagnosed in a hospital/health care facility


Secondary Outcome Measures :
  1. Positive oropharyngeal/nasal swab (PCR); [ Time Frame: 1 month ]
    Para-influenza-virus type 1, Para-influenza-virus type 2, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1, Respiratory Syncytial-Virus A, Respiratory Syncytial-Virus B, Influenza A virus or Influenza B virus

  2. Positive oropharyngeal/nasal swab (PCR); [ Time Frame: 1 month ]
    SAR-CoV-2, Para-influenza-virus type 1, Para-influenza-virus type 2, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1, Respiratory Syncytial-Virus A, Respiratory Syncytial-Virus B, Influenza A virus or Influenza B virus


Other Outcome Measures:
  1. Difference between the two study groups [ Time Frame: 1 month ]
    Returned swabs

  2. Discribtion of the face mask users psycological aspects of wearing face masks [ Time Frame: 1 month ]
    Psychological aspects of face mask wearing in the community

  3. Costs associated with wearing vs not wearing face masks [ Time Frame: 1 month ]
    Cost-effectiveness analyses on the use of surgical face masks

  4. Differences in the participants preferences [ Time Frame: 1 month ]
    Preference for self-conducted home swab vs. healthcare conducted swab at hospital or similar

  5. Difference between the two study groups [ Time Frame: 1 month ]
    Symptoms of COVID-19

  6. Difference between the two study groups with stratification between subgroups (age, gender, occupation, comorbidities) [ Time Frame: 1 month ]
    Self-assessed compliance with health authority guideline on hygiene

  7. Discribtion of the face mask users willingness to wear face masks [ Time Frame: 1 month ]
    Willingness to wear face masks in the future

  8. Healthcare diagnosed COVID-19 between study groups [ Time Frame: 1 month ]
    Healthcare diagnosed COVID-19 or identified SARS-CoV-2 infection as assessed by number of participants with antibodies against SARS-CoV-2, and/or positive maso/pharyngeal swab (PCR), mortality associated with COVID-19 and all cause mortality

  9. Hospital based diagnostics of bacteria between the two study groups [ Time Frame: 1 month ]
    Presence of bacteria: Mycoplasma pneumonia, Haemophilus influenza and Legionella pneumophila (to be obtained from registries when made available)

  10. Infection in the household between the two study groups [ Time Frame: 1 month ]
    Frequency of infected house-hold members between the two groups

  11. Sick leave among participants beteeen the two study groups [ Time Frame: 1 month ]
    Frequency of sick leave between the two groups (to be obtained from registries when made available)

  12. Predictors of primary outcome; age, gender, size of household, comorbidities, medications, social factors, occupation, mask compliance, compliance to general SARS-CoV-2 recommendations, hours outside home) [ Time Frame: 1 month ]
    Predictors of primary outcome or its components



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04337541


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Nordsjaellands Hospital
Hvidovre University Hospital
Herlev Hospital
Technical University of Denmark
Investigators
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Principal Investigator: 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 Nordsjællands Hospital
Publications:
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Responsible Party: Henning Bundgaard, Professor of Cardiology, Consultant, MD, DMSc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04337541    
Other Study ID Numbers: 2020-04-02
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection