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Completed

NCT Number: NCT04824625

Incidence of Infection Reported by COVID-19 in Attendees of a Commercial Music Concert

From the beginning of the pandemic caused by SARS-CoV-2, most events with massive participants have been canceled due to being considered high-risk events for the SARS-CoV-2 transmission. It has been detected that asymptomatic people infected by SARS-CoV-2, are playing an important role in the contagious in these kinds of events. The economic losses arising from the closure of these activities, mainly those related to culture and musical performances are around 2.5 billion euros a Catalonia, and a considerable loss of jobs in this sector.

Developing strategies of cribrate of infected people by SARS-CoV-2 asymptomatic or not diagnosticated and with a potential transmission of the virus is the key to perform cultural, sport, etc. massive events with all the security. The objective is to exclude infected people with a a high potential of transmission.

It is needed to use versatile tests for this objective, so the test must have a high sensibility to detect infected people, the test has to be easy to manipulate without requiring a high technology of the laboratory hospitals, neither prolongated to obtain a result and that has a low cost. The rapid SARS-CoV-2 antigen screening tests are best suited for this purpose.

On 27th March, a musical concert will be performed at Palau St Jordi (Barcelona) with 5000 attendees and with all the SARS-COV-2 safety measures by the "Secretary General of Health of the Generalitat de Catalunya" a (mandatory wearing a mask during the event, restricted outdoor areas of bar and smoking enhanced ventilation of the whole indoor area and avoiding queues.). This study wants to assess the incidence of SARS-CoV-2 infection reported to the health system among the attendees of this commercial concert during the 14 days following the event, also it will be evaluated the clinical evolution of the possible infections during the concert.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

About this study

From the beginning of the pandemic caused by SARS-CoV-2, most events with massive participants have been canceled due to being considered high-risk events for the SARS-CoV-2 transmission. It has been detected that asymptomatic people infected by SARS-CoV-2, are playing an important role in the contagious in these kinds of events. The economic losses arising from the closure of these activities, mainly those related to culture and musical performances are around 2.5 billion euros a Catalonia, and a considerable loss of jobs in this sector.

Developing strategies of cribrate of infected people by SARS-CoV-2 asymptomatic or not diagnosticated and with a potential transmission of the virus is the key to perform cultural, sport, etc. massive events with all the security. The objective is to exclude infected people with a a high potential of transmission.

It is needed to use versatile tests for this objective, so the test must have a high sensibility to detect infected people, the test has to be easy to manipulate without requiring a high technology of the laboratory hospitals, neither prolongated to obtain a result and that has a low cost. The rapid SARS-CoV-2 antigen screening tests are best suited for this purpose. These tests have shown a sensitivity close to 99% to detect infectious people who have a high viral load of SARS-CoV-2. No viral isolation has been demonstrated in any culture of samples of patients infected with SARS-CoV-2 with a Ct threshold (cycle threshold) in the test RT-PCR greater than 30, which is considered to delimit the transmitting potential of the infected

On 27th March, a musical concert will be performed at Palau St Jordi (Barcelona) with 5000 attendees and with all the SARS-COV-2 safety measures by the Secretaria General de Salut de la Generalitat de Catalunya (mandatory wearing a mask during the event, restricted outdoor areas of bar and smoking enhanced ventilation of the whole indoor area and avoiding queues.). This study wants to assess the incidence of SARS-CoV-2 infection reported to the health system among the attendees of this commercial concert during the 14 days following the event, also it will be evaluated the clinical evolution of the possible infections during the concert.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (> 18 years and under 65) attending the commercial music event scheduled at the Palau Sant Jordi
  • Sign informed consent, including an authorization for the collection of data from the electronic health system of the Catalan System of Health on the notification of COVID-19 infection during the 14 days following the event or authorization to be contacted by telephone by the medical team, if necessary, for complete information on SARS-CoV-2 infection.

Exclusion criteria

  • Minors (<18 years)

Treatment and study plan

Primary outcomes

  1. Incidence rate of people with SARS-CoV-2

    Time frame: From day 1 to day 14 after the event

    Incidence rate of assistants with reported SARS-COV-2 14 dys after the event

  2. Incidence rate of consultations in primary care centers

    Time frame: From day 1 to day 14 after the event

    Incidence rate of consultations in primary care centers about symptoms compatible with COVID-19 during the 14 days after the event

Secondary outcomes

  1. Incidence rate of Hospital emergencies

    Time frame: From day 1 to day 14 after the event

    Incidence rate of hospital emergencies about symptoms compatible with COVID-19 during the 14 days after the event

  2. Incidence rate of hospital admissions

    Time frame: From day 1 to day 14 after the event

    Incidence rate of hospital admissions about symptoms compatible with COVID-19 during the 14 days after the event

  3. Incidence rate of Intensive care units admissions

    Time frame: From day 1 to day 14 after the event

    Incidence rate of intensive care units in the concert participants with COVID-19 during the 14 days after the event

  4. Incidence rate of mortality

    Time frame: From day 1 to day 14 after the event

    Incidence rate of COVID-19 mortality in the concert participants during the 14 days after the event

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Festivals per la Cultura Segura AIE

Registry information

Official study title

Observational Study of the Incidence of Infection Reported by SARS CoV-2 in Attendees of a Commercial Music Concert at the Palau Sant Jordi (Barcelona)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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