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Immune Response of Asymptomatic EHPAD Employees Infected With COVID-19 (SERASYMPTO)

24. oktober 2022 opdateret af: Assistance Publique - Hôpitaux de Paris

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

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Paris, Frankrig, 75004
        • Hotel Dieu Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Cases
SARS-Cov-2 asymptomatic nursing homes employees
Andet: serology
serology at M3 and serology at M6
Andet: 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.
Andet: serology
serology at M3 and serology at M6

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
rate of positive IgG serology
Tidsramme: month 1-2 post infection
positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees
month 1-2 post infection

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
rate of positive IgG serology
Tidsramme: month 3-6 post infection
positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees
month 3-6 post infection
rate of positive immunoglobulin M (IgM) serology
Tidsramme: month 1-2-3 and 6 post infection
positive IgM SARS-Cov-2 serology after infection of asymptomatic employees
month 1-2-3 and 6 post infection
rate of neutralizing antibodies
Tidsramme: month 1-2-3 and 6 post infection
concentration of neutralizing antibodies
month 1-2-3 and 6 post infection
questionnaire
Tidsramme: month 1-2-3 and 6 post infection
Associated factors with the presence of antibodies
month 1-2-3 and 6 post infection
re infection
Tidsramme: through study completion, an average of 8 months
of asymptomatic patients with SARS-Cov-2
through study completion, an average of 8 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assistance Publique - Hôpitaux de Paris

Samarbejdspartnere

Institut Pasteur

Efterforskere

  • Ledende efterforsker: Dominique Salmon, MD, PhD, Assistance Publique - Hopitaux de Paris

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. juni 2022

Primær færdiggørelse (Faktiske)

18. juni 2022

Studieafslutning (Faktiske)

18. juni 2022

Datoer for studieregistrering

Først indsendt

19. november 2020

Først indsendt, der opfyldte QC-kriterier

19. november 2021

Først opslået (Faktiske)

22. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. oktober 2022

Sidst verificeret

1. oktober 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • APHP201253
  • 2020-A01833-36 (Anden identifikator: ID-RCB)

Plan for individuelle deltagerdata (IPD)

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