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Completed

NCT Number: NCT04429724

Health Professional Exposure Assessment to Covid-19

Understanding the SARS-Cov2 epidemic is a major public health issue, both in the community and in the hospital sector. Because of their central position in the management of patients infected with COVID-19, hospital staff may be considered at high risk of infection. The development of serological tests makes it possible to reliably document a contamination, symptomatic or not, that is more than 3 weeks old. These tests, combined with clinical questioning of the symptoms, make it possible to determine the proportion of asymptomatic infections whose impact in the transmission of this disease appears to be major. The duration of the presence of the antibodies that are hoped to neutralize after infection with CoV2-SARS remains uncertain. Documenting the evolution of antibody levels and their monitoring in a population at high risk of re-exposure to CoV2-SARS is a major issue in understanding this disease and in assessing the risk of infection among healthcare workers.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Roubaix, Roubaix, France

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About this study

This is a multi-center, prospective, interventional, low-risk, low-constraint, biological collection study to assess the exposure of health care workers to COVID-19.

Three blood samples will be taken at day 1, month 3 and month 6. The blood samples will be stored in a serum biological collection. A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.

In the event of the appearance of symptoms between samples, a self-questionnaire will be completed by the participating personnel as well as an invitation to screening by RT-PCR SARS Cov2 according to standard practices in force at the national level as well as an additional serological test.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Staff on duty in the health facility
  • Eligible to be drawn
  • Beneficiary subject affiliated or entitled to a social security scheme

Exclusion criteria

  • Minor patient
  • Refusal to participate
  • Patient under guardianship
  • Patient under guardianship

Treatment and study plan

Diagnostic test Covid-19

Diagnostic Test

Three blood samples will be taken at day 1, month 3 and month 6 A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.

Primary outcomes

  1. Number of contaminated personnel

    Time frame: day 1

    Number of contaminated personnel by occupational category and department on day 1.

Secondary outcomes

  1. Number of contaminated personnel

    Time frame: month 3

    Number of contaminated personnel by professional category and by service at month 3 a by serological test

  2. Number of contaminated personnel

    Time frame: month 6

    Number of contaminated personnel by professional category and by service at month 6 a by serological test

  3. Number of symptomatic staff by occupational category and service

    Time frame: month 3

    Number of symptomatic staff by occupational category and service at Month 3 with positive RT-PCR Cov2 SARS

  4. Number of symptomatic staff by occupational category and service

    Time frame: month 6

    Number of symptomatic staff by occupational category and service at Month 6 with positive RT-PCR Cov2 SARS

  5. Number of contaminated personnel with effective protection

    Time frame: evolution at day 1, month 3 and month 6

    Number of contaminated personnel with effective protection: evolution of the antibody index at day 1, month 3 and month 6

  6. comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies

    Time frame: month 6

    comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies between two stitch dates.

Sponsors and collaborators

Lead sponsor

Tourcoing Hospital

Other

Registry information

Acronym: SERODRON

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2020
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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