Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04824625 |
| Other study ID # |
StJordi-CoV |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 27, 2021 |
| Est. completion date |
April 10, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
