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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2021
Source French Society for Intensive Care
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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).

Locations

Country Name City State
France Centre des Congres Paris

Sponsors (1)

Lead Sponsor Collaborator
French Society for Intensive Care

Country where clinical trial is conducted

France, 

Outcome

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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