Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus
NCT ID: NCT04441710
Last Updated: 2023-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2777 participants
OBSERVATIONAL
2020-10-27
2022-12-16
Brief Summary
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The diagnosis of viral carriage by RT-PCR is reserved for symptomatic cases among caregivers, due to the shortage of available tests and the cumbersome implementation. The carrier diagnosis is the benchmark, on which are implemented the therapeutic strategies and established the national statistics. It can present false negatives, linked to a research too early or too late in relation to the infection, or to a technical defect of the nasal swab sample. Caregivers on the front line in patient care, in hospitals or in the city, have only partial access to this diagnostic test, depending on the existence of symptoms. The implementation of a systematic serological screening, planned by the government and which cannot be based only on the search for the virus, will make it possible to inform the caregivers presenting symptoms or not, of their serological status, and therefore of their degree immunity or, on the contrary, susceptibility to infectious contacts. It should therefore be very voluntarily requested. On the occasion of this screening, the constitution of the COVID-3S cohort will make it possible to verify the degree of contamination in an asymptomatic population, information which is sorely lacking for the estimation of the immune coverage of the population. The implementation of the Covid-3S study will be based on the work of the National Reference Center of Pr B Lina, from the COVID-SER cohort, for the selection of the most efficient test (s). It seems useful to initiate the constitution of this cohort as soon as possible in relation to the evolution of the epidemic. Pending receipt of official recommendations, the lack of knowledge of the performance of serological tests means that it should be applied first to health professionals, better able to appreciate its limits, for the initial period before determining a validated serological screening strategy. Once the strategy has been specified, the gradual expansion of screening to the patient population will provide a more representative basis for the construction of epidemiological models for evaluating strategies.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Caregivers
Staff of university hospitals
Questionnaire
Participants will be invited to complete a detailed questionnaire to collect prospectively and retrospectively data around the CoViD19 serological screening.
Primary care caregivers
Population of professional caregivers such as general practitioner or freelance nurse.
Questionnaire
Participants will be invited to complete a detailed questionnaire to collect prospectively and retrospectively data around the CoViD19 serological screening.
Patients
Questionnaire
Participants will be invited to complete a detailed questionnaire to collect prospectively and retrospectively data around the CoViD19 serological screening.
Interventions
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Questionnaire
Participants will be invited to complete a detailed questionnaire to collect prospectively and retrospectively data around the CoViD19 serological screening.
Eligibility Criteria
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Inclusion Criteria
* Any child under 18 who has passed a serological, antigenical, or any other type of test in France, willing to participate and at least one of whose parents has accepted to participate in the cohort, and/or vaccinated against COVID19
Exclusion Criteria
* Adults over whom legal protection applies: guardianship, curatorship
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Pascal FASCIA, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
François GUEYFFIER, MD
Role: STUDY_DIRECTOR
Hospices Civils de Lyon
Locations
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CHU de Grenoble - Hôpital Nord
La Tronche, , France
Hôpital de la Croix Rousse
Lyon, , France
CHU de Saint Etienne
Saint-Etienne, , France
Hôpital Henry Gabrielle
Saint-Genis-Laval, , France
Countries
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Other Identifiers
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69HCL20_0395
Identifier Type: -
Identifier Source: org_study_id
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