Covid19 Clinical Trial
— COVID-FREEOfficial 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
| NCT number | NCT04918160 |
| Other study ID # | 2021-A01185-36 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 8, 2021 |
| Est. completion date | July 2, 2021 |
| Verified date | October 2021 |
| Source | French Society for Intensive Care |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 711 |
| Est. completion date | July 2, 2021 |
| Est. primary completion date | July 2, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - Non-healthcare professional (exhibitors, congress center employees) - Refusal to participate to the study - Person under legal protection - Absence of social security affiliation |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre des Congres | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| French Society for Intensive Care |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | Day 7 of the last day of the meeting (June 18th, 2021) | |
| Secondary | 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). | Day 7 of the last day of the meeting (June 18th, 2021) | |
| Secondary | 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). | Day 21 of the last day of the congress (July 2, 2021) | |
| Secondary | 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). | Day 21 of the last day of the congress (July 2, 2021) | |
| Secondary | 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). | Day 21 of the last day of the congress (July 2, 2021) | |
| Secondary | 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). | Day 21 of the last day of the congress (July 2, 2021) |
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