Risk of Infection of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), COVID-19, in a Massive Musical Show With Transmission Prevention Measures

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.

Conditions

• COVID-19 (SARS-CoV-2)

Interventions

BEHAVIORAL

Participate in a massive musical event

Participate in a massive musical event

Sponsors & Collaborators

• Dr. Bonaventura Clotet Sala

  collaborator UNKNOWN

• Dr. Josep Mª LLibre Codina

  collaborator UNKNOWN

• Dr. Boris Revollo Barriga

  collaborator UNKNOWN

• Dra. Lidia Ruiz Tabuenca

  collaborator UNKNOWN

• Dr. Ignacio Blanco Guillermo

  collaborator UNKNOWN

• Dra. Andrea Alemany Ortiz

  collaborator UNKNOWN

• Dr. Roger Paredes Deiros

  collaborator UNKNOWN

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

  lead OTHER

Principal Investigators

• Bonaventura Clotet Sala, PhD, MD · Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

• Boris Revollo Barriga, PhD, MD · Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

• Josep Mª LLIBRRE CODINA, PhD, MD · Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-30

Primary Completion

2020-12-20

Completion

2021-01-08

Countries

• Spain

Study Locations