NCT04824625

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 27, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2021

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

Same day

First QC Date

March 27, 2021

Last Update Submit

April 15, 2021

Conditions

Keywords

SARS-CoV-2COVID-19CoronavirusSuperspreading eventConcert

Outcome Measures

Primary Outcomes (2)

  • Incidence rate of people with SARS-CoV-2

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

    From day 1 to day 14 after the event

  • Incidence rate of consultations in primary care centers

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

    From day 1 to day 14 after the event

Secondary Outcomes (4)

  • Incidence rate of Hospital emergencies

    From day 1 to day 14 after the event

  • Incidence rate of hospital admissions

    From day 1 to day 14 after the event

  • Incidence rate of Intensive care units admissions

    From day 1 to day 14 after the event

  • Incidence rate of mortality

    From day 1 to day 14 after the event

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the commercial concert attendees, that are major of age (\>18 years old) and who have signed the informed consent to access their Medical records 14 days after the commercial concert.

You may qualify if:

  • 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.

You may not qualify if:

  • Minors (\<18 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2021

First Posted

April 1, 2021

Study Start

March 27, 2021

Primary Completion

March 27, 2021

Study Completion

April 10, 2021

Last Updated

April 19, 2021

Record last verified: 2021-04

Locations