NCT04668625

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

Completed NA Last updated 8 February 2021

What this trial tests

NA trial testing Participate in a massive musical event in COVID-19 (SARS-CoV-2) in 1,000 participants. Completed in 8 January 2021.

Timeline

30 November 2020

Primary endpoint
20 December 2020

8 January 2021

Quick facts

Lead sponsor	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,000
Start date	30 November 2020
Primary completion	20 December 2020
Estimated completion	8 January 2021
Sites	1 location across Spain

Drugs / interventions tested

• Participate in a massive musical event

Conditions studied

• COVID-19 (SARS-CoV-2) — all drugs for COVID-19 (SARS-CoV-2) →

Sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia — full company profile →

Who can join

Adults 18 to 59, any sex, with COVID-19 (SARS-CoV-2). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Same-day SARS-CoV-2 antigen test screening in an indoor mass-gathering live music event: a randomised controlled trial.
   Revollo B, Blanco I, Soler P, Toro J, et al · · 2021 · cited 70× · PMID 34051886 · DOI 10.1016/s1473-3099(21)00268-1
2. Randomized trials on non-pharmaceutical interventions for COVID-19: a scoping review.
   Hirt J, Janiaud P, Hemkens LG. · · 2022 · cited 24× · PMID 35086864 · DOI 10.1136/bmjebm-2021-111825
3. Clinical trial research agenda on COVID-19 - the first two years in Germany and beyond.
   Hirt J, Janiaud P, Hemkens LG. · · 2022 · PMID 36180342 · DOI 10.1016/j.zefq.2022.08.003
4. Randomized trials on non-pharmaceutical interventions for COVID-19 as of August 2021: a meta-epidemiological analysis
   Hirt J, Janiaud P, Hemkens LG. · · 2021 · DOI 10.1101/2021.08.20.21261687
5. SARS-CoV-2 transmission in an indoor mass-gathering live music event. A randomized clinical trial.
   Llibre JM, Revollo B, Blanco I, Soler P, et al · · 2021 · DOI 10.21203/rs.3.rs-244584/v1