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

NCT04668625 | Completed

• 1 other identifier: PRIMACOV
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

SARS-CoV-2; COVID-19; Coronavirus; Superspreading event; Concert

Outcome Measures

Primary Outcomes (1)

• Incidence rate of people infected with SARS-CoV-2 8 days after randomization

  Incidence rate of people infected with SARS-CoV-2 8 days after randomization, detected by PCR in nasopharyngeal aspirate, on the experimental and the control group.

  At 8 days

Secondary Outcomes (7)

• SARS-CoV-2 genome sequence

  At 8 days

• Incidence rate of appearance of symptoms compatible with COVID 19

  At 10 days

• Time spent in testing the total number of participants in the study.

  At day 0

• Comparison of the diagnostic sensitivity of rapid antigen tests for SARS-CoV-2 compared to PCR in asymptomatic subjects.

  At day 0

• Comparison of the diagnostic sensitivity of rapid antigen tests for SARS-CoV-2 using a nasopharyngeal swab sample compared to sample obtained trough saliva

  At day 0

Study Arms (2)

Experimental group

EXPERIMENTAL

Participate in a massive musical event

Behavioral: Participate in a massive musical event

Control Group

NO INTERVENTION

Not participate in a massive musical event

Interventions

Participate in a massive musical event BEHAVIORAL

Participate in a massive musical event

Experimental group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults (age 18-59 years) with interest to attend the scheduled musical event who agree to participate in the study after signing the informed consent, including explicit acceptance of the measures implemented to reduce the risk of transmission of SARS-CoV-2.
• Negative antigen test performed up to 24 h before the event, in nasopharyngeal swab.

You may not qualify if:

• Hypertension
• Diabetes Mellitus.
• Ischemic heart disease.
• Any type of Cancer in active treatment.
• Chronic lung diseases such as chronic obstructive pulmonary disease (COPD) and asthma.
• Have a positive test for detection of SARS-CoV-2 by the rapid antigen test
• Who have a body temperature higher than 37.0º on the same day of the event
• Who have a confirmed diagnosis for SARS-CoV-2 in the two weeks prior to the event
• Report any symptoms suggestive of a SARS-CoV-2 infection in the 10 days prior to the study
• Who have been in contact with a person with a confirmed diagnosis of SARS-CoV-2 infection within two weeks prior to the event.
• Living with a person over 70 years of age (inclusive).

Sponsors & Collaborators

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: lead
• Dr. Bonaventura Clotet Sala: collaborator
• Dr. Josep Mª LLibre Codina: collaborator
• Dr. Boris Revollo Barriga: collaborator
• Dra. Lidia Ruiz Tabuenca: collaborator
• Dr. Ignacio Blanco Guillermo: collaborator
• Dra. Andrea Alemany Ortiz: collaborator
• Dr. Roger Paredes Deiros: collaborator

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Related Publications (1)

• Revollo B, Blanco I, Soler P, Toro J, Izquierdo-Useros N, Puig J, Puig X, Navarro-Perez V, Casan C, Ruiz L, Perez-Zsolt D, Videla S, Clotet B, Llibre JM. Same-day SARS-CoV-2 antigen test screening in an indoor mass-gathering live music event: a randomised controlled trial. Lancet Infect Dis. 2021 Oct;21(10):1365-1372. doi: 10.1016/S1473-3099(21)00268-1. Epub 2021 May 27.

  PMID: 34051886 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bonaventura Clotet Sala, PhD, MD

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

  PRINCIPAL INVESTIGATOR

• Boris Revollo Barriga, PhD, MD

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

  PRINCIPAL INVESTIGATOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will be screened for a rapid Ag SARS-CoV-2 test detection. All negative subjects will be randomized to an experimental arm (participate in a massive musical event) or to a control arm (not participate in a massive musical event).

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: November 30, 2020
• Primary Completion: December 20, 2020
• Study Completion: January 8, 2021
• Last Updated: February 8, 2021

Record last verified: 2021-01

Locations

ES (1)