Immune Response of Asymptomatic EHPAD Employees Infected With COVID-19 (SERASYMPTO)
Kinetic of Humoral Immune Response of Asymptomatic Nursing Homes (EHPAD) Employees Infected With Severe Acute Respiratory Syndrome Coronavirus : a Case Control Study
The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris France (EHPAD), where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2).
Few data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection.
The purpose of the study is to determine whether these asymptomatic persons develop a humoral immune response, whether this immune response is durable and whether it is protective against the risk of reinfection
Visão geral do estudo
Descrição detalhada
The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris, France, where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of SARS-Cov-2.
Few data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection.
The main objective of this study is to describe the SARS-Cov-2 asymptomatic employees with positive immunoglobulin G (igG) serology at month 1-2 post infection.
Secondary objectives are
- To describe the proportion of asymptomatic persons with SARS-Cov-2 antibodies month 3 and 6 post infection
- To compare the proportion of persons with SARS-Cov-2 antibodies between asymptomatic and asymptomatic carriers at M1-2 post infection, M3 and M6 post infection
- To determine the factors associated with the appearance of antibodies ( viral load, age, sex, previous history, habitus..)
- To study the neutralizing capacities and immune-profiling of SARS-Cov-2 antibodies in vitro
- To evaluate the occurrence of Coronavirus Disease 2019 (COVID-19) reinfections in asymptomatic carriers during the second wave.
The design will be a case control study between
- Cases: SARS-Cov-2 asymptomatic nursing homes employees
- Controls: cohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital.
Tipo de estudo
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Paris, França, 75004
- Hotel Dieu Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Common inclusion criteria:
- Age ≥ 18.
- Health care employees working in the EHPAD who consulted in the Hotel Dieu Hospital
- Affiliated with a health insurance
- Informed information and consent
Inclusion Criteria for Cases (asymptomatic COVID-19 patients) :
- Health care workers screened SARS-Cov-2 positive for NASopharyngeal swaths during screening campaigns for EHPAD staff.
- Having carried out a follow-up serology (M1 and M2) within the Hotel Dieu.
- Having never developed symptoms of COVID-19 or have developed some symptoms undetected before screening: fever, transient fatigue, rhinorrhea, symptoms that may be mistaken for a common winter cold (no respiratory symptoms or prolonged fever)
Inclusion criteria for controls (symptomatic COVID-19 patients) :
- Health care workers tested positive for polymerase chain reaction assay (PCR) SARS-Cov-2 during screening campaigns for EHPAD staff at the Hotel Dieu.
- Having carried out a follow-up serology (M1 and M2) within the Hotel Dieu.
COVID-19 symptoms defined by:
- At least two major signs of COVID-19 among: > fever, cough, chest tightness, bilateral pneumonia, anosmia, loss of taste.
- or a major sign and three minor signs among: headache, severe fatigue, diarrhea, odynophagia, rhinorrhea, suggestive skin signs.
It is part of the database of the virology department of Cochin Hospital (in case of failure to recruit health care workers in the EHPADs).
*Exclusion criteria :
- Refuse to participate or inability to obtain informed consent.
- under guardianship, curators
- negative SARS-COV-2 PCR
- Pregnancy
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: Cases
SARS-Cov-2 asymptomatic nursing homes employees
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serology at M3 and serology at M6
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Outro: Controls
cohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital.
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serology at M3 and serology at M6
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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rate of positive IgG serology
Prazo: month 1-2 post infection
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positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees
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month 1-2 post infection
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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rate of positive IgG serology
Prazo: month 3-6 post infection
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positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees
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month 3-6 post infection
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rate of positive immunoglobulin M (IgM) serology
Prazo: month 1-2-3 and 6 post infection
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positive IgM SARS-Cov-2 serology after infection of asymptomatic employees
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month 1-2-3 and 6 post infection
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rate of neutralizing antibodies
Prazo: month 1-2-3 and 6 post infection
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concentration of neutralizing antibodies
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month 1-2-3 and 6 post infection
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questionnaire
Prazo: month 1-2-3 and 6 post infection
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Associated factors with the presence of antibodies
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month 1-2-3 and 6 post infection
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re infection
Prazo: through study completion, an average of 8 months
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of asymptomatic patients with SARS-Cov-2
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through study completion, an average of 8 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dominique Salmon, MD, PhD, Assistance Publique - Hôpitaux de Paris
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- APHP201253
- 2020-A01833-36 (Outro identificador: ID-RCB)
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