Protective Measures Against SARS-CoV-2 Contamination of Young Healthy Volunteers During a Concert of Actual Music

NCT04868942 | Withdrawn

• 1 other identifier: ANRS0004s
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to assess whether the protective measures can limit the contaminations by SARS-CoV-2 during the participation in a concert at a non-inferior level to a non-concert / current life situation. A randomized, monocentric, open-label, non-inferiority study comparing, in two phases, a group of volunteers participating in a concert, protected by established protection measures, to a group with no other constraints than national recommendations and obligations (2 concerts, one control group at each concert). Volunteer students, between 18 and 30 years old, at Aix-Marseille University, will be recruited.

Conditions

Corona Virus Infection

Keywords

Coronavirus; Healthy volunteers; Social distancing; Prevention; Face masks

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 conversion rates

  PCR on saliva sample

  6 to 7 days after attending to the musical event

Secondary Outcomes (5)

• Respiratory virus conversion rates

  6 to 7 days after attending the concert

• Types and importance of barriers to prevention measures

  1 to 2 day before attending the concert

• Types and importance of levers for adherence to prevention measures

  1 to 2 days after attending the concert

• Seroprevalence of SARS-CoV-2 in volunteers

  1 to 2 days before attending the concert

• SARS-CoV-2 variants among participant positive cases

  6 to 7 days after attending the concert

Study Arms (2)

Participant assisting to the event

EXPERIMENTAL

Attending to musical event protected by established protection measures (protection kit, distancing, flow management, health mediation).

Other: Assisting to the event

Participant with no other constraints than national recommendations

NO INTERVENTION

A group control participant will not attend to the event

Interventions

Assisting to the event OTHER

Participant will attend a concert respecting the Following measures : * Individual protection kit: disposable FFP2 masks (3), Hydroalcoholic solution, disposable tissues, garbage bag, water bottle * Health mediation, information on barrier measures * Physical distancing (sitting participation) * Person flow management

Also known as: Attend a concert

Participant assisting to the event

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Student at Aix Marseille University
• who has declared that he or she does not carry any risk factor for severe forms of the disease (HCSP criteria of 29/10/2020)
• who has declared that he or she does not live under the same roof as a person who does carry such factors, and committed to strictly following the study's health protocol,
• carrying a smartphone which is registered on the "TousAntiCovid" application (with Bluetooth activation), and agreeing to install the Maela application on the smartphone for remote medical monitoring.

You may not qualify if:

• Volunteer with clinical signs of acute respiratory infectious disease
• Volunteer living with a person with clinical signs of acute respiratory infectious disease
• Volunteer with a risk factor for severe COVID-19
• Volunteer who had a COVID-19 infection in the 3 months prior to the study
• Volunteer who are not affiliated to the social security system
• Volunteer vaccinated against COVID-19
• Pregnant women and people living with pregnant women
• Persons deprived of liberty
• Adult with legal protection
• Volunteer unable to comply with protective measures, at the concert or at home
• Volunteer participating in another clinical research study

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale: collaborator
• Faculté des Sciences Médicales et Paramédicales: collaborator

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Fabrice Simon, Prof

  Faculté des Sciences Médicales et Paramédicales

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: A randomised, monocentric, open-label, non-inferiority study comparing, in two phases, a group of volunteers participating in a concert, protected by established protection measures (protection kit, distancing, flow management, health mediation), to a group with no other constraints than national recommendations and obligations (2 concerts, one control group at each concert).

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: May 3, 2021
• Study Start: May 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: May 1, 2022
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share