Risk of Infection of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), COVID-19, in a Massive Musical Show With Transmission Prevention Measures
Condition: COVID-19 (SARS-CoV-2)
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The coronavirus disease 2019 (COVID-19) outbreak, caused by the severe acute respiratory
      syndrome coronavirus 2 (SARS-CoV-2), emerged in Wuhan in December 2019 and has spread
      globally, representing a serious threat to public health. While waiting for highly effective
      treatments or the development of an effective vaccine, it is necessary to reactivate key
      economic activities that are related to leisure and culture in an environment that is safest
      for the participants.

      The use of a rapid screening test for SARS-CoV-2 viral antigens with high sensitivity could
      be a useful tool to detect asymptomatic SARS-CoV-2 infected people, and thus be able to carry
      out events related to leisure in a safe environment.

      The aim of this study is to make a mass screening of asymptomatic infection of an (i)
      experimental group (public attending a massive mass musical show) and (ii) a control group
      (they will not enter the event) prior to entering to the event.

      Randomization 1: 1 by random blocks of the participants with a negative antigen test in the
      experimental group (attending the event) and the control group (they will not enter the
      event).

      Control with a new Polymerase Chain Reaction (PCR) test 8 days after the event (D8) in the
      participants of both randomized groups Control of the appearance of symptoms through a
      questionnaire 10 days after the event (D10), in the participants of both groups with a
      negative result on day 8.

      Validation of a rapid antigen detection test by comparison with the PCR technique.

      The indoor activity will include an array of measures designed to reducing the contagion
      risk, including: mandatory wearing a mask during the event, restricted outdoor areas of bar
      and smoking, enhanced ventilation of the whole indoor area, and avoiding queues.

      All subjects will have downloaded an app in their smart phones to help contact and place
      tracing during the event, to trace potential transmissions. This app will remain active for 8
      days, until the last virologic control.

      The inclusion criteria will allow only subjects with an age <60 years, without comorbidities,
      and who do not live with old adults in their homes, to further reduce the risk of potential
      complications and transmission to at risk individuals.
    

Detailed description: 
      The coronavirus disease 2019 (COVID-19) outbreak, caused by the severe acute respiratory
      syndrome coronavirus 2 (SARS-CoV-2), emerged in Wuhan in December 2019 and has spread
      globally, representing a serious threat to public health. While 80% of patients are
      asymptomatic or have a mild illness, 20% develop a severe illness. The predominant symptoms
      include fever, cough, and myalgia. Mild disease can resolve without medical attention or it
      can progress to pneumonia and respiratory failure requiring hospitalization. Patients can
      rapidly progress to acute respiratory distress syndrome (ARDS) with multiple organ
      dysfunction and death.

      The degree to which the virus is infectious during the incubation period is uncertain, but it
      has been shown that the pharynx reaches peak viral load before day 5, and this peak viral
      load is 1,000 times higher than in severe acute respiratory syndrome coronavirus (SARS-CoV).
      This active and high viral clearance from the pharynx at a time when symptoms are still mild
      makes the transmission of SARS-CoV-2 more efficient than that of SARS-CoV. Later in the
      disease, COVID-19 resembles SARS in terms of replication in the lower respiratory tract. The
      decrease in viral load appears to be slow, and there is no sudden shedding of the virus at
      the time of seroconversion. Seroconversion, at the beginning of week 2, has been observed to
      coincide with a slow but steady decrease in sputum viral load. Prolonged viral shedding in
      sputum is relevant not only for infection control in hospitals and discharge management, but
      also for asymptomatic people who can transmit the virus for longer periods after infection.

      Although it is true that the majority of people infected by SARS-CoV-2 will have a benign
      course with few symptoms, approximately 20% will require hospitalization and 5% will present
      serious complications and admission to an intensive care unit, this is it translates into a
      saturation and collapse of health systems, with a high percentage of mortality in relation to
      it. Unprecedented confinement measures have been implemented that have been effective in
      containing the progression of the number of infections, but these have had a great social and
      economic impact, among others with a paralysis of most of the activities related to leisure
      (concerts , music festivals, theaters, etc.) that are an important component in the economy
      of most of the countries of the European community. While waiting for highly effective
      treatments or the development of an effective vaccine, it is necessary to reactivate key
      economic activities that are related to leisure and culture in an environment that is safest
      for the participants.

      The use of a rapid screening test for SARS-CoV-2 viral antigens with high sensitivity could
      be a useful tool to detect asymptomatic SARS-CoV-2 infected people, and thus be able to carry
      out events related to leisure in a safe environment.

      It is necessary to implement versatile circuits in which diagnoses with rapid tests can be
      carried out in the same place of the events in a massive way and to be able to communicate
      the results of the tests to the assistants at the same time, in order to do this screening of
      people that they give negative and carry out activities with them in a safe environment for
      all participants.

      The aim of this study is to make a mass screening of asymptomatic infection of an (i)
      experimental group (public attending a massive mass musical show) and (ii) a control group
      (they will not enter the event) prior to entering to the event.

      Randomization 1: 1 by random blocks of the participants with a negative antigen test in the
      experimental group (attending the event) and the control group (they will not enter the
      event).

      Control with a new PCR test 8 days after the event (D8) in the participants of both
      randomized groups Control of the appearance of symptoms through a questionnaire 10 days after
      the event (D10), in the participants of both groups with a negative result on day 8.

      Validation of a rapid antigen detection test by comparison with the PCR technique.

      The indoor activity will include an array of measures designed to reducing the contagion
      risk, including: mandatory wearing a mask during the event, restricted outdoor areas of bar
      and smoking, enhanced ventilation of the whole indoor area, and avoiding queues.

      All subjects will have downloaded an app in their smart phones to help contact and place
      tracing during the event, to trace potential transmissions. This app will remain active for 8
      days, until the last virologic control.

      The inclusion criteria will allow only subjects with an age <60 years, without comorbidities,
      and who do not live with old adults in their homes, to further reduce the risk of potential
      complications and transmission to at risk individuals.
    

Intervention name(s): Participate in a massive musical event
Intervention type(s): Behavioral
Intervention description(s): Participate in a massive musical event
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants will be screened for a rapid Ag SARS-CoV-2 test detection. All negative subjects will be randomized to an experimental arm (participate in a massive musical event) or to a control arm (not participate in a massive musical event).
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: SARS-CoV-2; COVID-19; Coronavirus; Superspreading event; Concert