- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04824625
Incidence of Infection Reported by COVID-19 in Attendees of a Commercial Music Concert
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)
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.
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Barcelona
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Badalona, Barcelona, Испания, 08916
- Germans Trias i Pujol Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
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)
Учебный план
Как устроено исследование?
Детали дизайна
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Incidence rate of people with SARS-CoV-2
Временное ограничение: From day 1 to day 14 after the event
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Incidence rate of assistants with reported SARS-COV-2 14 dys after the event
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From day 1 to day 14 after the event
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Incidence rate of consultations in primary care centers
Временное ограничение: 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
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From day 1 to day 14 after the event
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Incidence rate of Hospital emergencies
Временное ограничение: 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
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From day 1 to day 14 after the event
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Incidence rate of hospital admissions
Временное ограничение: 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
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From day 1 to day 14 after the event
|
Incidence rate of Intensive care units admissions
Временное ограничение: 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
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From day 1 to day 14 after the event
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Incidence rate of mortality
Временное ограничение: 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
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From day 1 to day 14 after the event
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- StJordi-CoV
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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