Corona Virus InfectionCONCERTSAFENCT04868942
Protective Measures Against SARS-CoV-2 Contamination of Young Healthy Volunteers During a Concert of Actual Music
A study testing Assisting to the event in people with Corona Virus Infection, run by ANRS, Emerging Infectious Diseases.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- Assisting to the event
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: Protective Measures Against SARS-CoV-2 Contamination of Healthy Voluntary Young Students During a Concert of Actual Music
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.
Read the 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, n=1125; Control A group, n=1125 Phase B (15 days later): Concert B group, n=1125; Control B group, n=1125
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 d'Azur) 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 (n=2250) D-2 to D-1: Phase A Inclusion visit (medical verification of inclusion criteria, information leaflet, consent form), 1:1 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 (n=1125) participating to the first concert after receiving the health kit and instructions at the entrance vs Controls A (n=1125), "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 n=10) for a sub-group of volunteers.
D0 to D10: Medical follow-up of Phase A volunteers; Q-A3 follow-up questionnaire
Phase B (n=2250) D13 to D14: Phase B Inclusion visit (medical verification of inclusion criteria, information leaflet, consent form), 1:1 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 (n=1125) participating to the first concert after receiving the health kit and instructions at the entrance vs Controls B (n=1125), "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 n=10) 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
- Conditions
- Corona Virus Infection
- Being tested
- Assisting to the event
- Keywords
- Coronavirus, Healthy volunteers, Social distancing, Prevention, Face masks
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisting to the eventOther
Also called Attend a concert
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
| Study group | Role | What they receive |
|---|---|---|
| Participant assisting to the event | Experimental | Attending to musical event protected by established protection measures (protection kit, distancing, flow management, health mediation). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 conversion rates
PCR on saliva sample
Measured: 6 to 7 days after attending to the musical event
Secondary outcomes (5)
Respiratory virus conversion rates
PCR on saliva sample
Measured: 6 to 7 days after attending the concert
Types and importance of barriers to prevention measures
Participant satisfaction survey using context-specific measures. A-Measures of perceived discomfort and perceived degradation of feelings Five points qualitative bipolar likert scale (four preventive behaviours items) minimum -2 to maximum 2, higher scores mean a better outcome.
- use of face mask
- physical distancing
- screening before admission
- motion monitoring in the concert hall
B-Measure of social gathering behaviors Five points qualitative bipolar likert scale (four behavioural items) minimum -2 to maximum 2, higher scores mean a better outcome.
- Socializing: talking to people
- Socializing: meeting new people
- Showing pleasure: singing or shouting
- Showing pleasure: Dancing
C-Measures overall satisfaction, using a single numeric item scale rated from 0 to 10 and an adapted Net Promoter Score scale.
Higher scores mean a better outcome.
Measured: 1 to 2 day before attending the concert
Types and importance of levers for adherence to prevention measures
Focus groups (after the concert)
Measured: 1 to 2 days after attending the concert
Seroprevalence of SARS-CoV-2 in volunteers
Assess SARS-CoV-2 seroprevalence in volunteers
Measured: 1 to 2 days before attending the concert
SARS-CoV-2 variants among participant positive cases
Identify SARS-CoV-2 variants by sequencing SARS-CoV-2 PCR positive cases
Measured: 6 to 7 days after attending the concert
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 May 2022 (estimated)
Why it stopped: The study didn't get the authorization from health authority
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale, Faculté des Sciences Médicales et Paramédicales
- Responsible party
- Sponsor
- Investigators
- Fabrice Simon, Prof, Principal investigator, Faculté des Sciences Médicales et Paramédicales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868942
- Sponsor's protocol ID
- ANRS0004s
- Acronym
- CONCERTSAFE
- Status last verified
- Dec 2021
- First submitted
- 16 Apr 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Measures Against SARS-CoV-2 Contamination of Healthy Voluntary Young Students During a Concert of Actual Music
- ClinicalTrials.gov ID
- NCT04868942
- Acronym / sponsor ID
- CONCERTSAFE / ANRS0004s
- Conditions
- Corona Virus Infection
- Keywords
- Coronavirus, Healthy volunteers, Social distancing, Prevention, Face masks
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study didn't get the authorization from health authority
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale, Faculté des Sciences Médicales et Paramédicales
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, n=1125; Control A group, n=1125 Phase B (15 days later): Concert B group, n=1125; Control B group, n=1125
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 d'Azur) 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 (n=2250) D-2 to D-1: Phase A Inclusion visit (medical verification of inclusion criteria, information leaflet, consent form), 1:1 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 (n=1125) participating to the first concert after receiving the health kit and instructions at the entrance vs Controls A (n=1125), "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 n=10) for a sub-group of volunteers.
D0 to D10: Medical follow-up of Phase A volunteers; Q-A3 follow-up questionnaire
Phase B (n=2250) D13 to D14: Phase B Inclusion visit (medical verification of inclusion criteria, information leaflet, consent form), 1:1 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 (n=1125) participating to the first concert after receiving the health kit and instructions at the entrance vs Controls B (n=1125), "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 n=10) 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Participant assisting to the event | Experimental | Other: Assisting to the eventAttending to musical event protected by established protection measures (protection kit, distancing, flow management, health mediation). |
| Participant with no other constraints than national recommendations | No intervention | –A group control participant will not attend to the event |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assisting to the eventAlso: Attend a concertParticipant 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 | Other | Participant assisting to the event |
Primary outcome
SARS-CoV-2 conversion rates
Time frame: 6 to 7 days after attending to the musical event
PCR on saliva sample
5 secondary outcomes
Respiratory virus conversion rates
Time frame: 6 to 7 days after attending the concert
Types and importance of barriers to prevention measures
Time frame: 1 to 2 day before attending the concert
Types and importance of levers for adherence to prevention measures
Time frame: 1 to 2 days after attending the concert
Seroprevalence of SARS-CoV-2 in volunteers
Time frame: 1 to 2 days before attending the concert
SARS-CoV-2 variants among participant positive cases
Time frame: 6 to 7 days after attending the concert
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice Simon, Prof principal investigator
Faculté des Sciences Médicales et Paramédicales
Questions about this trial
What is this clinical trial studying?
A study testing Assisting to the event in people with Corona Virus Infection, run by ANRS, Emerging Infectious Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 conversion rates (time frame: 6 to 7 days after attending to the musical event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.