Name (Synonyms) | Correlation |
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Name (Synonyms) | Correlation |
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There is one clinical trial.
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.
Description: Component 1 of primary endpoint: Positive oropharyngeal/nasal swab with SARS-CoV-2 (PCR) and/or
Measure: 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: 1 monthDescription: 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
Measure: 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: 1 monthDescription: Component 3 of primary endpoint: SARS-CoV-2 infection diagnosed in a hospital/health care facility
Measure: 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: 1 monthDescription: 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
Measure: Positive oropharyngeal/nasal swab (PCR); Time: 1 monthDescription: 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
Measure: Positive oropharyngeal/nasal swab (PCR); Time: 1 monthDescription: Returned swabs
Measure: Difference between the two study groups Time: 1 monthDescription: Psychological aspects of face mask wearing in the community
Measure: Discribtion of the face mask users psycological aspects of wearing face masks Time: 1 monthDescription: Cost-effectiveness analyses on the use of surgical face masks
Measure: Costs associated with wearing vs not wearing face masks Time: 1 monthDescription: Preference for self-conducted home swab vs. healthcare conducted swab at hospital or similar
Measure: Differences in the participants preferences Time: 1 monthDescription: Symptoms of COVID-19
Measure: Difference between the two study groups Time: 1 monthDescription: Self-assessed compliance with health authority guideline on hygiene
Measure: Difference between the two study groups with stratification between subgroups (age, gender, occupation, comorbidities) Time: 1 monthDescription: Willingness to wear face masks in the future
Measure: Discribtion of the face mask users willingness to wear face masks Time: 1 monthDescription: 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
Measure: Healthcare diagnosed COVID-19 between study groups Time: 1 monthDescription: Presence of bacteria: Mycoplasma pneumonia, Haemophilus influenza and Legionella pneumophila (to be obtained from registries when made available)
Measure: Hospital based diagnostics of bacteria between the two study groups Time: 1 monthDescription: Frequency of infected house-hold members between the two groups
Measure: Infection in the household between the two study groups Time: 1 monthDescription: Frequency of sick leave between the two groups (to be obtained from registries when made available)
Measure: Sick leave among participants beteeen the two study groups Time: 1 monthDescription: Predictors of primary outcome or its components
Measure: 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: 1 month