SARS-CoV-2ConcerTestNCT04896970
Risk of SARS-CoV-2 Infection (COVID-19) in a Standing Concert in a Closed Performance Hall
A study testing Concert in people with SARS-CoV-2, run by University Hospital, Montpellier.
Trial summary
The investigators want to compare the SARS-CoV-2 incidence 7 days after having been screened negative, between two groups of adults randomized to either go to a concert or not. Participants will be screened via a rapid saliva test a few hours before the show. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Concert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Jul 2021
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 18 and less than 60 years old
- Having completed the internet pre selection questionnaire and signed the consent form
- Negative rapid saliva RT-LAMP EasyCov test on the day of the show
- Social Security Affiliation
Who cannot join
- Serious form Covid-19 risk factors
- Positive saliva rapid test on the day of the event (and people who came with a positive person)
- History of SARS-CoV-2
- SARS-CoV-2 vaccination
- Living with a person older than 75 years old or having a serious form of Covid-19 risk factor
- Protection of a legal conservator
- Pregnant or breastfeeding women
- People living with a pregnant or breastfeeding woman
About this study
Official title: Risk of SARS-CoV-2 Infection in a Standing Concert in a Closed Performance Hall
The investigators want to compare the SARS-CoV-2 incidence 7 days after having been screened negative, between two groups of adults randomized to either go to a concert or not.
Participants will be screened via a rapid saliva test a few hours before the show. The hypothesis is that attending a standing concert in respect of safety precaution doesn't increase the risk of SARS-CoV-2 infection.
Read the detailed description
Context :
A previous Spanish randomized study in November 2020 concluded in a non superiority of the SARS-CoV-2 incidence in RT-PCR-negative participant of a concert compared to a control group. In the same way, investigators want to compare the SARS-CoV-2 incidence of participants of a concert 7 days after the show with a control group, using a saliva test.
While naso-pharyngeal RT-CPR is the gold-standard for virological SARS-COV-2 tests, this method can be painful and results take time. Saliva rapid tests have satisfactory diagnostic performances and easy access to results. Saliva rapid tests may lead to mass screening in cultural mass events.
This project has the specific feature to be set in closed concert hall with limited size attendance.
Methodology :
This experimental monocentric randomized non-inferiority will compare 2 parallel groups (with single blind for the screening tests results). The randomization will be centralised and stratified on the age.
Program :
Participants will be informed via an information notice and a preselection screening questionnaire on the internet. Eligible participants will have to come on the day of the show near the concert place to be included (after information and signing of the consent form). participants will receive a saliva sample tube.
Positively screened participants will have to go home. The others will be randomized in two groups. Participants will both have to come back 7 days after for the second screening.
Feasibility :
The concert place have a strong fan base to recruit participants from. To include all the participants, two concerts will take place, separated by a few days. Participants will receive goodies to maximize the chance of them attending to both screening.
This project received a methodological support from the Clinical and Epidemiological Research Unit of the Montpellier Hospital and is promoted by the Montpellier Hospital.
Sys2diag and SkillCell which developed the screening tests are involved as well as VOGO for the technical part and data management.
This project is financially helped by Région Occitanie, Montpellier Métropole, Saint-Jean-de-Vedas, SACEM, APEM, Tout à Fond and Boomerang.
- Conditions
- SARS-CoV-2
- Being tested
- Concert
- Keywords
- SARS-CoV-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConcertOther
A musical show in a closed hall, lasting for about 2 hours, in respects of safety measure (masks, hydroalcoholic gel, etc…) with approximately 200 participants.
| Study group | Role | What they receive |
|---|---|---|
| Concert | Experimental | Participants will go to a concert in a closed hall. Receives: Other: Concert |
| Control | No intervention | Participant will stay at home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 incidence
Rate of newly SARS-CoV-2 infected participants
Measured: 7 days after the first screening
Secondary outcomes (1)
Time to screen all participants
time spent to screen and have results for every participant of the concert
Measured: At screening day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study startJun 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: abandonment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896970
- Sponsor's protocol ID
- RECHMPL21_0110
- Acronym
- ConcerTest
- Status last verified
- Oct 2021
- First submitted
- 11 May 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of SARS-CoV-2 Infection in a Standing Concert in a Closed Performance Hall
- ClinicalTrials.gov ID
- NCT04896970
- Acronym / sponsor ID
- ConcerTest / RECHMPL21_0110
- Conditions
- SARS-CoV-2
- Keywords
- SARS-CoV-2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: abandonment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 21 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 investigators want to compare the SARS-CoV-2 incidence 7 days after having been screened negative, between two groups of adults randomized to either go to a concert or not.
Participants will be screened via a rapid saliva test a few hours before the show. The hypothesis is that attending a standing concert in respect of safety precaution doesn't increase the risk of SARS-CoV-2 infection.
Detailed description
Context :
A previous Spanish randomized study in November 2020 concluded in a non superiority of the SARS-CoV-2 incidence in RT-PCR-negative participant of a concert compared to a control group. In the same way, investigators want to compare the SARS-CoV-2 incidence of participants of a concert 7 days after the show with a control group, using a saliva test.
While naso-pharyngeal RT-CPR is the gold-standard for virological SARS-COV-2 tests, this method can be painful and results take time. Saliva rapid tests have satisfactory diagnostic performances and easy access to results. Saliva rapid tests may lead to mass screening in cultural mass events.
This project has the specific feature to be set in closed concert hall with limited size attendance.
Methodology :
This experimental monocentric randomized non-inferiority will compare 2 parallel groups (with single blind for the screening tests results). The randomization will be centralised and stratified on the age.
Program :
Participants will be informed via an information notice and a preselection screening questionnaire on the internet. Eligible participants will have to come on the day of the show near the concert place to be included (after information and signing of the consent form). participants will receive a saliva sample tube.
Positively screened participants will have to go home. The others will be randomized in two groups. Participants will both have to come back 7 days after for the second screening.
Feasibility :
The concert place have a strong fan base to recruit participants from. To include all the participants, two concerts will take place, separated by a few days. Participants will receive goodies to maximize the chance of them attending to both screening.
This project received a methodological support from the Clinical and Epidemiological Research Unit of the Montpellier Hospital and is promoted by the Montpellier Hospital.
Sys2diag and SkillCell which developed the screening tests are involved as well as VOGO for the technical part and data management.
This project is financially helped by Région Occitanie, Montpellier Métropole, Saint-Jean-de-Vedas, SACEM, APEM, Tout à Fond and Boomerang.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concert | Experimental | Other: ConcertParticipants will go to a concert in a closed hall. |
| Control | No intervention | –Participant will stay at home. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- At least 18 and less than 60 years old
- Having completed the internet pre selection questionnaire and signed the consent form
- Negative rapid saliva RT-LAMP EasyCov test on the day of the show
- Social Security Affiliation
Key exclusion criteria (8 listed)
- Serious form Covid-19 risk factors
- Positive saliva rapid test on the day of the event (and people who came with a positive person)
- History of SARS-CoV-2
- SARS-CoV-2 vaccination
- Living with a person older than 75 years old or having a serious form of Covid-19 risk factor
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 |
|---|---|---|
| ConcertA musical show in a closed hall, lasting for about 2 hours, in respects of safety measure (masks, hydroalcoholic gel, etc…) with approximately 200 participants. | Other | Concert |
Primary outcome
SARS-CoV-2 incidence
Time frame: 7 days after the first screening
Rate of newly SARS-CoV-2 infected participants
1 secondary outcome
Time to screen all participants
Time frame: At screening day
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 20 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Concert in people with SARS-CoV-2, run by University Hospital, Montpellier.
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 8 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 20 Oct 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 incidence (time frame: 7 days after the first screening). 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 20 Oct 2021.