Covid19SPRINGNCT04872075
Study on Prevention of SARS-CoV-2 Transmission During a Large Indoor Gathering Event
A study testing Concert, Rapid nasopharyngeal antigen test for Sars-Cov-2 and Saliva Sample in people with Covid19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objective is to demonstrate if there is no increase in the risk of Sars-Cov-2 salivary carriage 7 days after a concert in the group participating in the event compared to a non participating group who stayed at home. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Concert, Rapid nasopharyngeal antigen test for Sars-Cov-2 and Saliva Sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,678 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2021to 13 Jun 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged between 18 and 45 years old
- lack of symptoms or no contact with people with Covid-19 in the last two weeks
- negative antigenic test to Covid-19 in the 3 days before the experiment
- people who declared to have no risk factor to severe form of Covid-19
- people who declared not to live in the same place as someone with these risk factors
- people residing in Ile-de-France area
Who cannot join
- positive test to Sars-Cov-2 within 3 days before the concert
- people with clinical signs suggesting infectious respiratory disease
- people with severe Covid-19 risk factor
- people living with someone having severe covid-19 risk factor
- not affiliated to social security
- people who cannot remain standing for the time of the experimentation (about 5 hours)
Show all 9Show fewer
- person under tutorship or curatorship
- pregnant women or not having effective contraception method
- breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
The objective is to demonstrate if there is no increase in the risk of Sars-Cov-2 salivary carriage 7 days after a concert in the group participating in the event compared to a non participating group who stayed at home.
The hypothesis is that a systematic screening of Sars-Cov-2 within the 3 days before the event allows to control the risk of transmission and prevent cluster of transmission during the concert.
Read the detailed description
Before inclusion, the participants will be able to pre-register to the event via a website. They will get an appointment for an inclusion visit at the Accor Arena (Paris Bercy, France).
During 3 days (from D-3 to D-1), participants with a registration will come to the Accor Arena to have a rapid Sars-Cov-2 antigen test (results in 15 min).
If the test is positive, the participant will be contacted and managed by the medical team in charge of the national strategy for positives cases.
People with a negative test will be included and randomized :
- Two kits with tube for collecting saliva samples (for D0 and D7) will be given to each participant at this visit
- People randomized in the experimental group will receive their concert ticket at a later date.
- At Day 0, people randomized in the experimental group, will come to the Accor Arena with their ticket to participate in the concert. At the entrance, they should give their D0 saliva sampling kit. The people randomized in the control group will stay at home and will send their D0 saliva sample by post mail.
- At Day 7 (±1 day) all the participants must return their D7 saliva sampling kit via post mail
- Conditions
- Covid19
- Being tested
- Concert, Rapid nasopharyngeal antigen test for Sars-Cov-2, Saliva Sample
- Keywords
- Sars-Cov-2, Covid-19, Screening, Concert, Closed area, Standing configuration
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConcertOther
People attending a concert in a closed area, with a mask
Rapid nasopharyngeal antigen test for Sars-Cov-2Diagnostic test
A nasopharyngeal swab at inclusion (up to 3 days before concert) to confirm eligibility
Saliva SampleDiagnostic test
Saliva samples sent by participant at Day0 and Day7
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | People at the concert Receives: Other: Concert; Diagnostic Test: Rapid nasopharyngeal antigen test for Sars-Cov-2; Diagnostic Test: Saliva Sample |
| Control | Active comparator | People staying at home Receives: Diagnostic Test: Rapid nasopharyngeal antigen test for Sars-Cov-2; Diagnostic Test: Saliva Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a positive salivary RT-PCR at day 7 after the date of the concert
Prove the lack of increase of salivary carriage risk of SARS-CoV-2 on day 7 in participants present at the concert (experimental group) compared to non-participants at the event (control group)
Measured: 7 days after the concert (-1/+8 days)
Secondary outcomes (5)
Number of participants in each group with a positive salivary RT-PCR the day of the concert
Evaluation of the salivary carriage on day 0 (the concert day) despite a negative test within 3 days before the event and the conversion rate of salivary carriage between D0 and D7
Measured: The day of the concert
Molecular analysis of transmission clusters
Comparison of the sequence of complete viral genome in participant with a positive test at day 7
Measured: 7 days after the concert (-1/+8 days)
Average percentage of participants wearing their mask adequately for the duration of event
Estimate the overall compliance of the mask wearing by the participants during the duration of the event (covering nose and mouth)
Measured: The day of the concert
Percentage of adequate mask wearing among participants according to location and time
Identify the circumstances (place, time) of failure of accurate mask wearing by the participants
Measured: The day of the concert
Percentage of participants who downloaded and / or used the TousAntiCovid application at the time of inclusion
Estimate the feasibility and acceptability of using the Tousanticovid application
Measured: The day of the concert
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start26 May 2021
- Primary completion13 Jun 2021
- Study completion13 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- PRODISS, WEEZEVENT, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Constance DELAUGERRE, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872075
- Sponsor's protocol ID
- APHP210504
- Other IDs
- 2021-A01264-37
- Acronym
- SPRING
- Status last verified
- Sep 2025
- First submitted
- 29 Apr 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Delaugerre C, Foissac F, Abdoul H, Masson G, Choupeaux L, Dufour E, Gastli N, Delarue SM, Nere ML, Minier M, Gabassi A, Salmona M, Seguineau M, Schmitt S, Tonglet S, Olivier A, Poyart C, Le Goff J, Lescure X, Kerneis S, Treluyer JM; SPRING study group. Prevention of SARS-CoV-2 transmission during a large, live, indoor gathering (SPRING): a non-inferiority, randomised, controlled trial. Lancet Infect Dis. 2022 Mar;22(3):341-348. doi: 10.1016/S1473-3099(21)00673-3. Epub 2021 Nov 26.
PubMed 34843662
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Prevention of SARS-CoV-2 Transmission During a Large Indoor Gathering Event
- ClinicalTrials.gov ID
- NCT04872075
- Acronym / sponsor ID
- SPRING / APHP210504
- Conditions
- Covid19
- Keywords
- Sars-Cov-2, Covid-19, Screening, Concert, Closed area, Standing configuration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,678 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- PRODISS, WEEZEVENT, URC-CIC Paris Descartes Necker Cochin
- Study start
- 26 May 2021 (actual)
- Primary completion
- 13 Jun 2021 (actual)
- Study completion
- 13 Jun 2021 (actual)
- First posted
- 4 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 objective is to demonstrate if there is no increase in the risk of Sars-Cov-2 salivary carriage 7 days after a concert in the group participating in the event compared to a non participating group who stayed at home.
The hypothesis is that a systematic screening of Sars-Cov-2 within the 3 days before the event allows to control the risk of transmission and prevent cluster of transmission during the concert.
Detailed description
Before inclusion, the participants will be able to pre-register to the event via a website. They will get an appointment for an inclusion visit at the Accor Arena (Paris Bercy, France).
During 3 days (from D-3 to D-1), participants with a registration will come to the Accor Arena to have a rapid Sars-Cov-2 antigen test (results in 15 min).
If the test is positive, the participant will be contacted and managed by the medical team in charge of the national strategy for positives cases.
People with a negative test will be included and randomized :
- Two kits with tube for collecting saliva samples (for D0 and D7) will be given to each participant at this visit
- People randomized in the experimental group will receive their concert ticket at a later date.
- At Day 0, people randomized in the experimental group, will come to the Accor Arena with their ticket to participate in the concert. At the entrance, they should give their D0 saliva sampling kit. The people randomized in the control group will stay at home and will send their D0 saliva sample by post mail.
- At Day 7 (±1 day) all the participants must return their D7 saliva sampling kit via post mail
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Concert, Diagnostic Test: Rapid nasopharyngeal antigen test for Sars-Cov-2, Diagnostic Test: Saliva SamplePeople at the concert |
| Control | Active comparator | Diagnostic Test: Rapid nasopharyngeal antigen test for Sars-Cov-2, Diagnostic Test: Saliva SamplePeople staying at home |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- aged between 18 and 45 years old
- lack of symptoms or no contact with people with Covid-19 in the last two weeks
- negative antigenic test to Covid-19 in the 3 days before the experiment
- people who declared to have no risk factor to severe form of Covid-19
- people who declared not to live in the same place as someone with these risk factors
Key exclusion criteria (9 listed)
- positive test to Sars-Cov-2 within 3 days before the concert
- people with clinical signs suggesting infectious respiratory disease
- people with severe Covid-19 risk factor
- people living with someone having severe covid-19 risk factor
- not affiliated to social security
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 |
|---|---|---|
| ConcertPeople attending a concert in a closed area, with a mask | Other | Experimental |
| Rapid nasopharyngeal antigen test for Sars-Cov-2A nasopharyngeal swab at inclusion (up to 3 days before concert) to confirm eligibility | Diagnostic test | Control, Experimental |
| Saliva SampleSaliva samples sent by participant at Day0 and Day7 | Diagnostic test | Control, Experimental |
Primary outcome
Number of participants with a positive salivary RT-PCR at day 7 after the date of the concert
Time frame: 7 days after the concert (-1/+8 days)
Prove the lack of increase of salivary carriage risk of SARS-CoV-2 on day 7 in participants present at the concert (experimental group) compared to non-participants at the event (control group)
5 secondary outcomes
Number of participants in each group with a positive salivary RT-PCR the day of the concert
Time frame: The day of the concert
Molecular analysis of transmission clusters
Time frame: 7 days after the concert (-1/+8 days)
Average percentage of participants wearing their mask adequately for the duration of event
Time frame: The day of the concert
Percentage of adequate mask wearing among participants according to location and time
Time frame: The day of the concert
Percentage of participants who downloaded and / or used the TousAntiCovid application at the time of inclusion
Time frame: The day of the concert
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publication: PubMed 34843662Delaugerre C, Foissac F, Abdoul H, Masson G, Choupeaux L, Dufour E, Gastli N, Delarue SM, Nere ML, Minier M, Gabassi A, Salmona M, Seguineau M, Schmitt S, Tonglet S, Olivier A, Poyart C, Le Goff J, Lescure X, Kerneis S, Treluyer JM; SPRING study group. Prevention of SARS-CoV-2 transmission during a large, live, indoor gathering (SPRING): a non-inferiority, randomised, controlled trial. Lancet Infect Dis. 2022 Mar;22(3):341-348. doi: 10.1016/S1473-3099(21)00673-3. Epub 2021 Nov 26.
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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.
Constance DELAUGERRE, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concert, Rapid nasopharyngeal antigen test for Sars-Cov-2 and Saliva Sample in people with Covid19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with a positive salivary RT-PCR at day 7 after the date of the concert (time frame: 7 days after the concert (-1/+8 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04872075, which also lists 1 linked publication.
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 Nov 2025.