COVID-19 Seroconversion Among Front Line Medical and Paramedical Staff in Emergency, Intensive Care Units and Infectious Disease Departments During the 2020 Epidemic

Not Applicable

Completed

• Conditions: Sars-CoV2
• Interventions: Other: blood sample

• Registration Number: NCT04304690
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The epidemic due to the Sars-CoV2 virus is spreading in France, without knowning precisely since when the virus has actually circulated on the territory. Data from China but also systematic samples taken from the passengers of the Diamond Princess boat also report almost 50% of asymptomatic forms of Covid-19. The medical and paramedical staff of the front-line services for the care of patients infected with Covid-19 are in fact potentially exposed to the risk of occupational contamination due to the large number of patients treated, including in the pre-epidemic phase. Therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract Covid-19 disease, including in its asymptomatic form.

Detailed Description

The epidemic due to Sars-CoV2 is spreading in France, without it being knowning precisely since when the virus actually circulated on the territory. Data from China but also systematic samples taken from the passengers of the boat Diamond Princess also report almost 50% of asymptomatic forms of Covid-19. Medical and paramedical staff are in fact potentially exposed to the risk of professional contamination, with probably a different risk between the first-line referent hospitals and the others, due to the large number of patients treated in the first, including in the pre-epidemic phase (average of 190 consultants per day at the emergency department Pitié-Salpêtrière for example). Therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract Covid-19 disease, including in its asymptomatic form. Knowledge of this seroconversion rate, if it is found to be higher than that of the general population, could lead to a review of the measures to protect personnel from other emerging infectious risks.

Study Timeline

• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-11
• Study Start: 2020-03-16
• Primary Completion: 2021-07-07
• Study Completion: 2021-07-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1177

Inclusion Criteria

• Any permanent medical or paramedic staff of participating services who have given written consent to participate
• Having a social security insurance.

Exclusion Criteria

• Non-permanent staff (occasional staffing), administrative staff, technical staff of participating services.
• Staff who were not active during the inclusion period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
caregiver	blood sample	caregivers from emergency, ICU, virology and infectious disease services

Primary Outcome Measures

Name	Time	Method
Quantify the proportion of patients with documented Sars-CoV2 infection among medical and paramedical staff	3 months	Sars-CoV2 seroconversion is defined by a T0 sample with no specific antibody (negative) and M3 sample with the presence of specific IgG.

Secondary Outcome Measures

Name	Time	Method
Identification of risk factors for seroconversion	3 months	"Age, gender, type of staff, medical staff: resident, Clinic Chief or University Hospital Assistant (CCA / AHU), Associate Practitioner (PA), Contractual Hospital Practitioner (PHC), Hospital Practitioner (PH), Lecturer-Hospital Practitioner (MCU-PH) , University Professor-Hospital Practitioner (PUPH) non-medical staff: nursing assistants (AS), nurses (IDE), physiotherapist, managers, others, Seniority in the profession (number of years) Service tenure (years), Night, day, day or mixed work, Type of service: emergency department, infectious disease service, ICU), Type of hospital (firstline reference hospital or not), Documented contact with a confirmed patient."
" Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome "	3 months	"Description of symptomatic infections; * Clinical manifestations associated with seroconversion.; * On the intermediate sample if necessary, performed within 10 days of the start of a clinical picture compatible with an acute Sars-CoV2 infection (fever, body aches, headache, sweating, chills + respiratory picture (cough dyspnea, sputum, ) or digestive (nausea / vomiting diarrhea abdominal pain) "
Quantify the proportion of asymptomatic infections among staff who have seroconverted	3 months	"Seroconversion without clinical manifestation (fever, body aches, headache, sweating, chills + respiratory symptoms (cough dyspnea, sputum) or digestive (nausea / vomiting diarrhea abdominal pain) reported via the weekly self-monitoring booklet.; The asymptomatic characteristics will be determined by an adjudication committee, in the light of the weekly self-monitoring notebooks, without knowing the results of the serologies."

Trial Locations

Locations (1)

Hopital Pitié Salpetrière; 🇫🇷 Paris, France