Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868942
Status:
WITHDRAWN
Last Update Posted:
2021-12-30
First Post:
2021-04-16
Brief Title:
Protective Measures Against SARS-CoV-2 Contamination of Young Healthy Volunteers During a Concert of Actual Music
Sponsor:
ANRS Emerging Infectious Diseases
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Protective Measures Against SARS-CoV-2 Contamination of Healthy Voluntary Young Students During a Concert of Actual Music
Status:
WITHDRAWN
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study didnt get the authorization from health authority
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONCERTSAFE
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
Detailed Description:
Objectives
Primary objective To assess whether the protective measures implemented individual protection kit including disposable FFP2 filtering facepiece masks hydro-alcoholic solution water bottle disposable tissues waste bag physical distancing flow management and health mediation make it possible to limit contamination by SARS-CoV-2 during participation in a concert lasting 2 hours at a non-inferior level to a non-concert situation
Secondary objectives
To assess whether the protective measures implemented individual protection kit including disposable FFP2 masks hydro-alcoholic solution water bottle disposable tissues waste bag physical distancing flow management and health mediation make it possible to limit contamination by other circulating respiratory viruses during participation in a concert lasting 2 hours at a non-inferior level to a non-concert situation
To assess whether the protection against viral contamination in the absence of a one-seat gap between 2 volunteers is non-inferior to the protection induced by one-seat gap sub-group of volunteers
To assess knowledge attitudes and practices regarding COVID-19
To assess the level of compliance and adherence to the prevention measures implemented during the concert
To assess SARS-CoV-2 serology prevalence in volunteers
To identify SARS-CoV-2 variants by sequencing SARS-CoV-2 PCR positive cases
Methodology design 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 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
Sample size
4500 participants in 2 phases Phase A Concert A group n1125 Control A group n1125 Phase B 15 days later Concert B group n1125 Control B group n1125
Endpoints
Primary Endpoint
Conversion of salivary SARS-CoV-2 carriage detected by molecular biology at Day 6 or 7 after each event
Secondary endpoints
Conversion of salivary carriage of other respiratory viruses detected by molecular biology at Day 6 or 7 after each event
Level of knowledge about COVID-19 and methods of protection
Verbatim from the qualitative interview on knowledge attitudes and practices
Adherence score for protective measures
Percentage of initially positive SARS-CoV-2 serology in the volunteer sample
Percentages of SARS-CoV-2 variants among positive samples for each variant
Intervention
During the music concert 2 hours prevention measures
Individual protection kit disposable FFP2 masks 3 hydro-alcoholic solution disposable tissues garbage bag water bottle
Health mediation information on barrier measures
Physical distancing sitting participation
Person flow management
Statistical Plan
Primary analysis
The intervention effect will be estimated by the difference in SARS-CoV-2 conversion rates PCR
The main non-inferiority analysis will be performed by interval estimation of the difference in PCR SARS-CoV-2 conversion rates in Per Protocol each volunteer being associated with the concert or control group according to his or her actual participation over the 2 concerts using a multilevel mixed model with random period effect An Intention-to-Treat analysis will also be performed
Secondary analyses
Analysis of individual knowledge and behavior and adherence to protection measures Q1- questionnaire Q1 Q2 and Q3 unsupervised exploratory analyses - classification on principal component analysis
Estimation of the difference in PCR conversion rates SARS-CoV-2 and other respiratory viruses adjusted for the level of knowledge and behavior obtained from the questionnaires for the collective level of protection observed during the concert ad hoc observations and for the epidemic situation at the time of the concerts Estimations will be provided by using a multilevel multivariate logistic model This approach will eventually allow us to introduce a random period effect to consider the temporality of the measurements Finally we analyze the level of the epidemic by IRIS smallest french geographical area each week in collaboration with the ARS-PACA Health Regional Agency - Agence Regionale de Santé - Provence Alpes Cote dAzur and SPF French National Public Health Agency - Santé Publique France If necessary an adjustment on this possible spatial effect will be made based on the address of the volunteers to estimate the risk of contamination of the control group exponential-power variogram
Serology prevalence will be estimated and associated behavioral factors will be assessed by using multilevel multivariate logistic regression
Analyses will be performed in Per Protocol and Intent to Treat
A secondary analysis with imputation of missing data will be performed as a sensitivity analysis after testing the hypothesis of missing at random
A 5 significance level will be used for decision making but the probabilities will be interpreted accordingly
Provisional timetable follow-up of volunteers
D-30 to D-16 logistic organization D-15 information about the study communication in the media call for volunteers D-10 to D-2 selection of eligible volunteers
Phase A n2250 D-2 to D-1 Phase A Inclusion visit medical verification of inclusion criteria information leaflet consent form 11 randomization into two groups of 1125 volunteers Concert A and Control A self-collection of PS-A1 saliva sample Prélèvement Salivaire and Q-A1-baseline questionnaire at one of the dedicated university campuses explanation of instructions self-collection for serology D0 Concert A group n1125 participating to the first concert after receiving the health kit and instructions at the entrance vs Controls A n1125 usual life D1 to D2 Q-A2 adherence questionnaire D6 to D7 Phase A control visit self-collection of the PS-A2 saliva sample at one of the dedicated university campuses reminder of instructions interviews focus group n10 for a sub-group of volunteers
D0 to D10 Medical follow-up of Phase A volunteers Q-A3 follow-up questionnaire
Phase B n2250 D13 to D14 Phase B Inclusion visit medical verification of inclusion criteria information leaflet consent form 11 randomization into two groups of 1125 volunteers Concert B and Control B self-collection of PS-B1 saliva sample and Q-B1-baseline questionnaire at one of the dedicated university campuses explanation of instructions self-collection for serology D15 Concert B group n1125 participating to the first concert after receiving the health kit and instructions at the entrance vs Controls B n1125 usual life D16 to D17 Q-B2 adherence questionnaire D21 to D22 Phase B control visit self-collection of the PS-B2 saliva sample at one of the dedicated university campuses reminder of instructions interviews focus group n10 for a sub-group of volunteers
D14 to D25 Medical follow-up of Phase B volunteers Q-B3 follow-up questionnaire
Analyses
D10 to D32 Biological sample processing D25 to D40 Questionnaire processing D35 to D65 Primary statistical analyses D65-D365 Secondary analyses
Primary objective To assess whether the protective measures implemented individual protection kit including disposable FFP2 filtering facepiece masks hydro-alcoholic solution water bottle disposable tissues waste bag physical distancing flow management and health mediation make it possible to limit contamination by SARS-CoV-2 during participation in a concert lasting 2 hours at a non-inferior level to a non-concert situation
Secondary objectives
To assess whether the protective measures implemented individual protection kit including disposable FFP2 masks hydro-alcoholic solution water bottle disposable tissues waste bag physical distancing flow management and health mediation make it possible to limit contamination by other circulating respiratory viruses during participation in a concert lasting 2 hours at a non-inferior level to a non-concert situation
To assess whether the protection against viral contamination in the absence of a one-seat gap between 2 volunteers is non-inferior to the protection induced by one-seat gap sub-group of volunteers
To assess knowledge attitudes and practices regarding COVID-19
To assess the level of compliance and adherence to the prevention measures implemented during the concert
To assess SARS-CoV-2 serology prevalence in volunteers
To identify SARS-CoV-2 variants by sequencing SARS-CoV-2 PCR positive cases
Methodology design 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 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
Sample size
4500 participants in 2 phases Phase A Concert A group n1125 Control A group n1125 Phase B 15 days later Concert B group n1125 Control B group n1125
Endpoints
Primary Endpoint
Conversion of salivary SARS-CoV-2 carriage detected by molecular biology at Day 6 or 7 after each event
Secondary endpoints
Conversion of salivary carriage of other respiratory viruses detected by molecular biology at Day 6 or 7 after each event
Level of knowledge about COVID-19 and methods of protection
Verbatim from the qualitative interview on knowledge attitudes and practices
Adherence score for protective measures
Percentage of initially positive SARS-CoV-2 serology in the volunteer sample
Percentages of SARS-CoV-2 variants among positive samples for each variant
Intervention
During the music concert 2 hours prevention measures
Individual protection kit disposable FFP2 masks 3 hydro-alcoholic solution disposable tissues garbage bag water bottle
Health mediation information on barrier measures
Physical distancing sitting participation
Person flow management
Statistical Plan
Primary analysis
The intervention effect will be estimated by the difference in SARS-CoV-2 conversion rates PCR
The main non-inferiority analysis will be performed by interval estimation of the difference in PCR SARS-CoV-2 conversion rates in Per Protocol each volunteer being associated with the concert or control group according to his or her actual participation over the 2 concerts using a multilevel mixed model with random period effect An Intention-to-Treat analysis will also be performed
Secondary analyses
Analysis of individual knowledge and behavior and adherence to protection measures Q1- questionnaire Q1 Q2 and Q3 unsupervised exploratory analyses - classification on principal component analysis
Estimation of the difference in PCR conversion rates SARS-CoV-2 and other respiratory viruses adjusted for the level of knowledge and behavior obtained from the questionnaires for the collective level of protection observed during the concert ad hoc observations and for the epidemic situation at the time of the concerts Estimations will be provided by using a multilevel multivariate logistic model This approach will eventually allow us to introduce a random period effect to consider the temporality of the measurements Finally we analyze the level of the epidemic by IRIS smallest french geographical area each week in collaboration with the ARS-PACA Health Regional Agency - Agence Regionale de Santé - Provence Alpes Cote dAzur and SPF French National Public Health Agency - Santé Publique France If necessary an adjustment on this possible spatial effect will be made based on the address of the volunteers to estimate the risk of contamination of the control group exponential-power variogram
Serology prevalence will be estimated and associated behavioral factors will be assessed by using multilevel multivariate logistic regression
Analyses will be performed in Per Protocol and Intent to Treat
A secondary analysis with imputation of missing data will be performed as a sensitivity analysis after testing the hypothesis of missing at random
A 5 significance level will be used for decision making but the probabilities will be interpreted accordingly
Provisional timetable follow-up of volunteers
D-30 to D-16 logistic organization D-15 information about the study communication in the media call for volunteers D-10 to D-2 selection of eligible volunteers
Phase A n2250 D-2 to D-1 Phase A Inclusion visit medical verification of inclusion criteria information leaflet consent form 11 randomization into two groups of 1125 volunteers Concert A and Control A self-collection of PS-A1 saliva sample Prélèvement Salivaire and Q-A1-baseline questionnaire at one of the dedicated university campuses explanation of instructions self-collection for serology D0 Concert A group n1125 participating to the first concert after receiving the health kit and instructions at the entrance vs Controls A n1125 usual life D1 to D2 Q-A2 adherence questionnaire D6 to D7 Phase A control visit self-collection of the PS-A2 saliva sample at one of the dedicated university campuses reminder of instructions interviews focus group n10 for a sub-group of volunteers
D0 to D10 Medical follow-up of Phase A volunteers Q-A3 follow-up questionnaire
Phase B n2250 D13 to D14 Phase B Inclusion visit medical verification of inclusion criteria information leaflet consent form 11 randomization into two groups of 1125 volunteers Concert B and Control B self-collection of PS-B1 saliva sample and Q-B1-baseline questionnaire at one of the dedicated university campuses explanation of instructions self-collection for serology D15 Concert B group n1125 participating to the first concert after receiving the health kit and instructions at the entrance vs Controls B n1125 usual life D16 to D17 Q-B2 adherence questionnaire D21 to D22 Phase B control visit self-collection of the PS-B2 saliva sample at one of the dedicated university campuses reminder of instructions interviews focus group n10 for a sub-group of volunteers
D14 to D25 Medical follow-up of Phase B volunteers Q-B3 follow-up questionnaire
Analyses
D10 to D32 Biological sample processing D25 to D40 Questionnaire processing D35 to D65 Primary statistical analyses D65-D365 Secondary analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None