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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04304690
Recruitment Status : Active, not recruiting
First Posted : March 11, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sars-CoV2 Other: blood sample Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: COVID-19 Seroconversion Among Medical and Paramedical Staff in Emergency, ICU and Infectious Disease Services During the 2020 Epidemic
Actual Study Start Date : March 16, 2020
Estimated Primary Completion Date : May 16, 2021
Estimated Study Completion Date : October 16, 2021

Arm Intervention/treatment
caregiver
caregivers from emergency, ICU, virology and infectious disease services
Other: blood sample
2 blood samples at T0 and 3 months




Primary Outcome Measures :
  1. Quantify the proportion of patients with documented Sars-CoV2 infection among medical and paramedical staff [ Time Frame: 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 :
  1. Identification of risk factors for seroconversion [ Time Frame: 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."

  2. Quantify the proportion of asymptomatic infections among staff who have seroconverted [ Time Frame: 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."


  3. " Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome " [ Time Frame: 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) "



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304690


Locations
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France
Hopital Pitié Salpetrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04304690    
Other Study ID Numbers: APHP200310
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Emergencies
Disease Attributes
Pathologic Processes