Covid19COVID-FREENCT04918160
Evaluation of the Sanitary Safety of a Healthcare Professional Conference Held 9-11 June 2021 in Paris
An observational study of Covid19, run by French Society for Intensive Care at 1 site in France.
Trial summary
The COVID-SRLF study will evaluate the sanitary safety of the French Intensive Care Society (FICS) annual meeting held in Paris Congress Center from June 9th to June 11th 2021 in the Coronavirus Disease 2019 (COVID-2019) pandemic situation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Exposure to the FICS annual meeting (June 9-11 2021, Paris Congress Center)
- How many people
- 711 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2021to 2 Jul 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two cohorts of healthy volunteers will be followed during 21 days after the French Intensive Care Society annual meeting. A first cohort, Conference Attendees cohort, constituted of volunteering healthcare practitioners (medical doctor, nurse, nurse assistant, physiotherapist and psychotherapist) attending the FICS annual congress. The second cohort, Control cohort, will gather volunteering healthcare practitioners (medical doctor, nurse, nurse assistant, physiotherapist and psychotherapist) who dit not attend the FICS annual congress, recruited in the same medical departments as the Conference Attendees participants.
Who may be able to join
- Healthcare professional healthy volunteer
- Absence of COVID-19 symptoms in the 2 weeks prior to inclusion
- Not being a COVID-19 contact case in the 2 weeks prior to inclusion
- Participation to at least one day of the FICS annual meeting (June 9-11 2021)
Who cannot join
- Non-healthcare professional (exhibitors, congress center employees)
- Refusal to participate to the study
- Person under legal protection
- Absence of social security affiliation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Sanitary Safety of the French Intensive Care Society Annual Meeting Held From June 9th to June 11th 2021 at the Paris Congress Centre
The COVID-SRLF study will evaluate the sanitary safety of the French Intensive Care Society (FICS) annual meeting held in Paris Congress Center from June 9th to June 11th 2021 in the Coronavirus Disease 2019 (COVID-2019) pandemic situation. The primary objective is to determine the proportion of attendees with a positive antigenic COVID-19 screening test at day 7 (+/- 1) of their participation to the meeting. This rate will be compared to a cohort of health care professionals (medical doctors and paramedical professionals) from the same hospital ward as the attendees but who did not attend the meeting (stratified on centers, gender, age (< and >= 40 years, vaccination status (0, 1 or 2 doses) and socio-professional status (medical doctor, nurse, nurse assistant).
- Conditions
- Covid19
- Being tested
- Exposure to the FICS annual meeting (June 9-11 2021, Paris Congress Center)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to the FICS annual meeting (June 9-11 2021, Paris Congress Center)Other
The study will compare COVID-19 screening nasal antigenic self-test (Boiron Auto Test Covid Nasal) positivity at D7 and COVID-19 symptoms in the 21 days between participants to the FICS annual meeting held in June 9-11 2021 in the Paris Congress Center (conference attendees / exposed) and healthcare professionals who did not attend the meeting (controls / not exposed).
| Study group | Role | What they receive |
|---|---|---|
| Conference Attendees | Volunteering healthcare practitioners (medical doctor, nurse, nurse assistant, physiotherapist and psychotherapist) attending the FICS annual congress will be proposed to participate to the study.
After giving their consent, participants will be asked to perform a COVID-19 antigenic screening self-test at day 7 (+/- 1) of the last day of the meeting (June 11th 2021) and to fill a questionnaire at day 21 of the last day of the meeting (June 11th 2021). Receives: Other: Exposure to the FICS annual meeting (June 9-11 2021, Paris Congress Center) | |
| Controls | Volunteering healthcare practitioners (medical doctor, nurse, nurse assistant, physiotherapist and psychotherapist) not attending the FICS annual congress will be proposed to participate to the study. They will be recruited in the same medical departments as the Conference Attendees.
After giving their consent, controls will be asked to perform a COVID-19 antigenic screening self-test at day 7 (+/- 1) of the last day of the meeting (June 11th 2021) and to fill a questionnaire at day 21 of the last day of the meeting (June 11th 2021). Receives: Other: Exposure to the FICS annual meeting (June 9-11 2021, Paris Congress Center) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conference attendees COVID-19 prevalence at D7
Proportion of conference attendees with a positive COVID-19 autotest at day 7 of the last day of the meeting (June 18th, 2021).
Measured: Day 7 of the last day of the meeting (June 18th, 2021)
Secondary outcomes (5)
Controls COVID-19 prevalence at D7
Proportion of controls (healthcare professional not participating to the conference) with a positive COVID-19 autotest at day 7 of the last day of the meeting (June 18th, 2021).
Measured: Day 7 of the last day of the meeting (June 18th, 2021)
Proportion of conference attendees with COVID-19 symptoms at D21
Proportion of conference attendees reporting COVID-19 compatible symptoms until day 21 of the last day of the congress (July 2, 2021).
Measured: Day 21 of the last day of the congress (July 2, 2021)
Proportion of conference attendees with COVID-19-related medical consultation at D21
Proportion of conference attendees reporting COVID-19-related medical consultation until day 21 of the last day of the congress (July 2, 2021).
Measured: Day 21 of the last day of the congress (July 2, 2021)
Proportion of conference attendees with COVID-19-related emergency department visit at D21
Proportion of conference attendees reporting COVID-19-related emergency department visit until day 21 of the last day of the congress (July 2, 2021).
Measured: Day 21 of the last day of the congress (July 2, 2021)
Proportion of conference attendees with COVID-19-related hospitalisation at D21
Proportion of conference attendees reporting COVID-19-related hospitalisation until day 21 of the last day of the congress (July 2, 2021).
Measured: Day 21 of the last day of the congress (July 2, 2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start8 Jun 2021
- Primary completion2 Jul 2021
- Study completion2 Jul 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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Society for Intensive Care
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Maury, MD, PhD, Principal investigator, French Society for Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918160
- Sponsor's protocol ID
- 2021-A01185-36
- Acronym
- COVID-FREE
- Status last verified
- Oct 2021
- First submitted
- 2 Jun 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
SRLF Trial Group. Sanitary safety of the 2021 French Intensive Care Society medical conference: a case/control study. Ann Intensive Care. 2022 Feb 11;12(1):11. doi: 10.1186/s13613-022-00986-x.
PubMed 35147794
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Sanitary Safety of the French Intensive Care Society Annual Meeting Held From June 9th to June 11th 2021 at the Paris Congress Centre
- ClinicalTrials.gov ID
- NCT04918160
- Acronym / sponsor ID
- COVID-FREE / 2021-A01185-36
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- French Society for Intensive CareUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 8 Jun 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 COVID-SRLF study will evaluate the sanitary safety of the French Intensive Care Society (FICS) annual meeting held in Paris Congress Center from June 9th to June 11th 2021 in the Coronavirus Disease 2019 (COVID-2019) pandemic situation. The primary objective is to determine the proportion of attendees with a positive antigenic COVID-19 screening test at day 7 (+/- 1) of their participation to the meeting. This rate will be compared to a cohort of health care professionals (medical doctors and paramedical professionals) from the same hospital ward as the attendees but who did not attend the meeting (stratified on centers, gender, age (< and >= 40 years, vaccination status (0, 1 or 2 doses) and socio-professional status (medical doctor, nurse, nurse assistant).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conference Attendees | – | Other: Exposure to the FICS annual meeting (June 9-11 2021, Paris Congress Center)Volunteering healthcare practitioners (medical doctor, nurse, nurse assistant, physiotherapist and psychotherapist) attending the FICS annual congress will be proposed to participate to the study. After giving their consent, participants will be asked to perform a COVID-19 antigenic screening self-test at day 7 (+/- 1) of the last day of the meeting (June 11th 2021) and to fill a questionnaire at day 21 of the last day of the meeting (June 11th 2021). |
| Controls | – | Other: Exposure to the FICS annual meeting (June 9-11 2021, Paris Congress Center)Volunteering healthcare practitioners (medical doctor, nurse, nurse assistant, physiotherapist and psychotherapist) not attending the FICS annual congress will be proposed to participate to the study. They will be recruited in the same medical departments as the Conference Attendees. After giving their consent, controls will be asked to perform a COVID-19 antigenic screening self-test at day 7 (+/- 1) of the last day of the meeting (June 11th 2021) and to fill a questionnaire at day 21 of the last day of the meeting (June 11th 2021). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two cohorts of healthy volunteers will be followed during 21 days after the French Intensive Care Society annual meeting. A first cohort, Conference Attendees cohort, constituted of volunteering healthcare practitioners (medical doctor, nurse, nurse assistant, physiotherapist and psychotherapist) attending the FICS annual congress. The second cohort, Control cohort, will gather volunteering healthcare practitioners (medical doctor, nurse, nurse assistant, physiotherapist and psychotherapist) who dit not attend the FICS annual congress, recruited in the same medical departments as the Conference Attendees participants.
Key inclusion criteria (4 listed)
- Healthcare professional healthy volunteer
- Absence of COVID-19 symptoms in the 2 weeks prior to inclusion
- Not being a COVID-19 contact case in the 2 weeks prior to inclusion
- Participation to at least one day of the FICS annual meeting (June 9-11 2021)
Key exclusion criteria (4 listed)
- Non-healthcare professional (exhibitors, congress center employees)
- Refusal to participate to the study
- Person under legal protection
- Absence of social security affiliation
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 |
|---|---|---|
| Exposure to the FICS annual meeting (June 9-11 2021, Paris Congress Center)The study will compare COVID-19 screening nasal antigenic self-test (Boiron Auto Test Covid Nasal) positivity at D7 and COVID-19 symptoms in the 21 days between participants to the FICS annual meeting held in June 9-11 2021 in the Paris Congress Center (conference attendees / exposed) and healthcare professionals who did not attend the meeting (controls / not exposed). | Other | Conference Attendees, Controls |
Primary outcome
Conference attendees COVID-19 prevalence at D7
Time frame: Day 7 of the last day of the meeting (June 18th, 2021)
Proportion of conference attendees with a positive COVID-19 autotest at day 7 of the last day of the meeting (June 18th, 2021).
5 secondary outcomes
Controls COVID-19 prevalence at D7
Time frame: Day 7 of the last day of the meeting (June 18th, 2021)
Proportion of conference attendees with COVID-19 symptoms at D21
Time frame: Day 21 of the last day of the congress (July 2, 2021)
Proportion of conference attendees with COVID-19-related medical consultation at D21
Time frame: Day 21 of the last day of the congress (July 2, 2021)
Proportion of conference attendees with COVID-19-related emergency department visit at D21
Time frame: Day 21 of the last day of the congress (July 2, 2021)
Proportion of conference attendees with COVID-19-related hospitalisation at D21
Time frame: Day 21 of the last day of the congress (July 2, 2021)
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 21 Oct 2021.
- Derived from this study: PubMed 35147794SRLF Trial Group. Sanitary safety of the 2021 French Intensive Care Society medical conference: a case/control study. Ann Intensive Care. 2022 Feb 11;12(1):11. doi: 10.1186/s13613-022-00986-x.
- Individual participant dataSharing planned: No
Related trials for Covid19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
Eric Maury, MD, PhD principal investigator
French Society for Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by French Society for Intensive Care 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 4 inclusion and 4 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 21 Oct 2021. 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?
Conference attendees COVID-19 prevalence at D7 (time frame: Day 7 of the last day of the meeting (June 18th, 2021)). 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 NCT04918160, 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 21 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.