Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus

NCT04441710 | Completed

• 1 other identifier: 69HCL20_0395
• Study Type: observational
• Target: 2,777
• Locations: 1 country
• Sites: 4

Brief Summary

Hospital mortality attributed to SARS-CoV-2 in France increased daily by 28% in the week before confinement. The week following this decision, the daily increase was 30%. During the week of the second week of confinement, it started a decline of 19% estimated over the last 5 days, reaching the cumulative number of 2606 deaths on 29/3 (site https://www.eficiens.com/coronavirus- personal statistics / and calculation). 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.

Conditions

COVID

Keywords

COVID-19; SARS-COV-2; Serology; Predictability

Outcome Measures

Primary Outcomes (1)

• Establishment of a reliable prediction model for the effectiveness of virus control

  Estimated number of deaths avoided by the various population protection strategies, estimated by applying these strategies to the realistic virtual population.

  18 months

Study Arms (3)

Caregivers

Staff of university hospitals

Other: Questionnaire

Primary care caregivers

Population of professional caregivers such as general practitioner or freelance nurse.

Other: Questionnaire

Patients

Other: Questionnaire

Interventions

Questionnaire OTHER

Participants will be invited to complete a detailed questionnaire to collect prospectively and retrospectively data around the CoViD19 serological screening.

Caregivers; Patients; Primary care caregivers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective cohort of voluntary caregivers, initially recruited in the CHUs concerned, then among the primary care caregivers, finally among the patients whom these caregivers care for.

You may qualify if:

• Any adult having passed a serological, antigenical or any other type of test in France, and voluntary to participate in the cohort and/or vaccinated against COVID19
• 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

You may not qualify if:

• Persons deprived of their liberty
• Adults over whom legal protection applies: guardianship, curatorship

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (4)

CHU de Grenoble - Hôpital Nord

La Tronche, France

Location

Hôpital de la Croix Rousse

Lyon, France

Location

CHU de Saint Etienne

Saint-Etienne, France

Location

Hôpital Henry Gabrielle

Saint-Genis-Laval, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Pascal FASCIA, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• François GUEYFFIER, MD

  Hospices Civils de Lyon

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: October 27, 2020
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: February 3, 2023

Record last verified: 2023-02

Locations

FR (4)