NCT04918160

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
711

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 8, 2021

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

24 days

First QC Date

June 2, 2021

Last Update Submit

October 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Controls COVID-19 prevalence at D7

    Day 7 of the last day of the meeting (June 18th, 2021)

  • Proportion of conference attendees with COVID-19 symptoms at D21

    Day 21 of the last day of the congress (July 2, 2021)

  • Proportion of conference attendees with COVID-19-related medical consultation at D21

    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

    Day 21 of the last day of the congress (July 2, 2021)

  • Proportion of conference attendees with COVID-19-related hospitalisation at D21

    Day 21 of the last day of the congress (July 2, 2021)

Study Arms (2)

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).

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).

Other: Exposure to the FICS annual meeting (June 9-11 2021, Paris Congress Center)

Interventions

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).

Conference AttendeesControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Healthcare professional healthy volunteer
  • Participation to at least one day of the FICS annual meeting (June 9-11 2021)

You may not qualify if:

  • Non-healthcare professional (exhibitors, congress center employees)
  • Refusal to participate to the study
  • Person under legal protection
  • Absence of social security affiliation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre des Congres

Paris, 75017, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Eric Maury, MD, PhD

    French Society for Intensive Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 8, 2021

Study Start

June 8, 2021

Primary Completion

July 2, 2021

Study Completion

July 2, 2021

Last Updated

October 21, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations