Study on Prevention of SARS-CoV-2 Transmission During a Large Indoor Gathering Event (SPRING)
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Concert
Rapid nasopharyngeal antigen test for Sars-Cov-2
Saliva Sample
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring Sars-Cov-2, Covid-19, Screening, Concert, Closed area, Standing configuration
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- person under tutorship or curatorship
- pregnant women or not having effective contraception method
- breastfeeding women
Sites / Locations
- AccorHotels Arena
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
People at the concert
People staying at home
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Molecular analysis of transmission clusters
Comparison of the sequence of complete viral genome in participant with a positive test at day 7
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)
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
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
Full Information
NCT ID
NCT04872075
First Posted
April 29, 2021
Last Updated
July 12, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
PRODISS, WEEZEVENT
1. Study Identification
Unique Protocol Identification Number
NCT04872075
Brief Title
Study on Prevention of SARS-CoV-2 Transmission During a Large Indoor Gathering Event
Acronym
SPRING
Official Title
Study on Prevention of SARS-CoV-2 Transmission During a Large Indoor Gathering Event
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
June 13, 2021 (Actual)
Study Completion Date
June 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
PRODISS, WEEZEVENT
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Sars-Cov-2, Covid-19, Screening, Concert, Closed area, Standing configuration
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6678 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
People at the concert
Arm Title
Control
Arm Type
Active Comparator
Arm Description
People staying at home
Intervention Type
Other
Intervention Name(s)
Concert
Intervention Description
People attending a concert in a closed area, with a mask
Intervention Type
Diagnostic Test
Intervention Name(s)
Rapid nasopharyngeal antigen test for Sars-Cov-2
Intervention Description
A nasopharyngeal swab at inclusion (up to 3 days before concert) to confirm eligibility
Intervention Type
Diagnostic Test
Intervention Name(s)
Saliva Sample
Intervention Description
Saliva samples sent by participant at Day0 and Day7
Primary Outcome Measure Information:
Title
Number of participants with a positive salivary RT-PCR at day 7 after the date of the concert
Description
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)
Time Frame
7 days after the concert (-1/+8 days)
Secondary Outcome Measure Information:
Title
Number of participants in each group with a positive salivary RT-PCR the day of the concert
Description
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
Time Frame
The day of the concert
Title
Molecular analysis of transmission clusters
Description
Comparison of the sequence of complete viral genome in participant with a positive test at day 7
Time Frame
7 days after the concert (-1/+8 days)
Title
Average percentage of participants wearing their mask adequately for the duration of event
Description
Estimate the overall compliance of the mask wearing by the participants during the duration of the event (covering nose and mouth)
Time Frame
The day of the concert
Title
Percentage of adequate mask wearing among participants according to location and time
Description
Identify the circumstances (place, time) of failure of accurate mask wearing by the participants
Time Frame
The day of the concert
Title
Percentage of participants who downloaded and / or used the TousAntiCovid application at the time of inclusion
Description
Estimate the feasibility and acceptability of using the Tousanticovid application
Time Frame
The day of the concert
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
person under tutorship or curatorship
pregnant women or not having effective contraception method
breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance DELAUGERRE, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
AccorHotels Arena
City
Paris
ZIP/Postal Code
75012
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
34843662
Citation
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.
Results Reference
derived
Learn more about this trial
Study on Prevention of SARS-CoV-2 Transmission During a Large Indoor Gathering Event
We'll reach out to this number within 24 hrs