NCT04304690

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

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

March 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

March 16, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2021

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

March 9, 2020

Last Update Submit

July 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quantify the proportion of patients with documented Sars-CoV2 infection among medical and paramedical staff

    Sars-CoV2 seroconversion is defined by a T0 sample with no specific antibody (negative) and M3 sample with the presence of specific IgG.

    3 months

Secondary Outcomes (3)

  • Identification of risk factors for seroconversion

    3 months

  • Quantify the proportion of asymptomatic infections among staff who have seroconverted

    3 months

  • " Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome "

    3 months

Study Arms (1)

caregiver

OTHER

caregivers from emergency, ICU, virology and infectious disease services

Other: blood sample

Interventions

2 blood samples at T0 and 3 months

caregiver

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Non-permanent staff (occasional staffing), administrative staff, technical staff of participating services.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Pitié Salpetrière

Paris, 75013, France

Location

Related Publications (1)

  • Hausfater P, Boutolleau D, Lacombe K, Beurton A, Dumont M, Constantin JM, Ghosn J, Combes A, Cury N, Guedj R, Djibre M, Bompard R, Mazerand S, Pourcher V, Gimeno L, Marois C, Teyssou E, Marcelin AG, Hajage D, Tubach F. Cumulative incidence of SARS-CoV-2 infection and associated risk factors among frontline health care workers in Paris: the SEROCOV cohort study. Sci Rep. 2022 May 4;12(1):7211. doi: 10.1038/s41598-022-10945-y.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 11, 2020

Study Start

March 16, 2020

Primary Completion

July 7, 2021

Study Completion

July 7, 2021

Last Updated

July 6, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations