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Medical and Serological Follow-up of the Staff of the Paris Saint-Joseph Hospital Group Infected With Severe Acute Respiratory Syndrome Coronavirus 2.

Medical and Serological Follow-up of the Staff of the Paris Saint-Joseph Hospital Group

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04488484
Acronym
PERSO-COVID
Enrollment
80
Registered
2020-07-28
Start date
2020-07-01
Completion date
2022-05-23
Last updated
2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19, coronavirus, SARS-CoV2

Brief summary

The Coronavirus SARS CoV-2 (COVID-19) pandemic is causing a major global health crisis that is disrupting our hospital organizations and creating potential infectious risks for hospital staff on the front line when it comes to the support of infected people. In this context, the Paris Saint-Joseph Hospital Group (GhPSJ) very early on wanted to implement an institutional approach aimed, on the one hand, at enabling each of its employees at its two sites (Hôpital Paris Saint-Joseph (HPSJ), Paris 14ème and Hôpital Marie Lannelongue (HML), Le Plessis Robinson, 92) to access their serological status with regard to SARS-CoV-2 and, on the other hand, to identify the risk factors for contracting COVID-19. This collective approach consisted of an evaluation of its professional practices aimed at assessing the protective measures put in place to protect hospital personnel and identifying sources of potential improvement in the management of the infectious risk required to put in place in case of upcoming COVID-19 cases or any other epidemics in the future.

Detailed description

This institutional process had been validated by senior management and staff representative bodies. It was based on voluntary work, anonymity, the confidential aspect of the employees' analyses with the establishment of a follow-up and an individual counselling organized by the Occupational Health Service (SST) team and a team of COVID-19 Serology referents appointed to carry out and coordinate this process. Among the 3,600 GhPSJ employees, 3,062 (85%) samples were taken (and 404 employees from partner establishments in the hospital complex) for an initial serology test between April, 20th and May,15th and a second test one month later (M1) between May 18th and June 12th. The purpose of this second sampling was to get rid of the fear of another infection that might have occurred on the date of the first serology, and to observe the evolution between the two samples at the end of the epidemic phase. The first results identified 310 people (231 from the HPSJ site and 56 from the HML site) (10.1%) with a positive serology for SARS CoV-2. However, it was observed that the people infected by the COVID-19, had highly variable IgG antibody titers and these titers changed unexpectedly. In fact, the majority of cases (89%) showed a drop in antibody titers as early as the first month and 20 of them (6.4%) even showed a negativation based on the index of quantitative ELISAs performed. After only 5 months of hindsight in the face of this new pandemic, there are a few robust and specific data on the immune response following the COVID-19 and its involvement in the clinical impact on infected patients. In addition to the epidemiological interest and potential protection, the use of the immune response is an important therapeutic issue that is currently being evaluated, whether for passive immunization or primary prevention, with highly anticipated prospects for vaccination of populations. It should be noted that the severely infected patients present characteristics unique to COVID-19 that are rarely seen in other respiratory viral infections, such as severe lymphopenia and eosinopenia, pneumonia and extensive lung damage, cytokine storm leading to acute respiratory distress syndrome and multisystem failure, and numerous atypical presentations (ENT, digestive, mucocutaneous, etc.). A high viral load at the time of first infection and/or repeated exposures to the virus, particularly for healthcare professionals, may be an important factor in the evolution of the disease (severe clinical forms, delayed clinical signs and particular serological kinetics). In this context, the team in charge of coordinating the institutional project, in connection with the Occupational Health Service (SST) which followed all the personnel exposed during the epidemic period, wishes to propose to the GhPSJ personnel who desires a longitudinal follow-up as part of a research approach aimed at describing the kinetics of the antibodies produced following a COVID-19 infection and a medical follow-up including a self-questionnaire and a consultation specifically targeting the delayed clinical presentations after COVID-19 accompanied by a longitudinal serological follow-up over a longer period.

Interventions

OTHERSerology test follow-up

The enrolled participants will be invited to visit ESS. They will then meet the occupational physician, who wil obtain their free, informed and written consent. The information and consent will be recorded in the personal medical follow-up file.The staff will then complete the self-questionnaire and the ESS physician will provide a prescription for the blood samples to be taken. In case of positive answers to one or more of the questions in this self-questionnaire, the enrolled participant will be contacted in order to schedule another post-COVID-19 consultation with additional examinations if needed (new COVID PCR, scanner, etc.).

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

The research is a prospective, follow-up cohort, non-randomized and interventional study that aims at following patients who presented a positive serology for the COVID-19

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* employee aged over 18 years * employee who participated to the serology tests * employee who was tested positively to the Covid-19 serology test * French speaking employee * employee affiliated to a French social security or any other health insurance system. * employee who is able to give its free and written consent.

Exclusion criteria

* employee under guardianship or curatorship * employee deprived of liberty * employee under the protection of justice.

Design outcomes

Primary

MeasureTime frameDescription
Evolution of the SARS-CoV2 overtime1 month (after the 1st serology test results)the serology test will observe the evolution of the COVID-19 over time, its impact on the staff infected and the memory carried by the associated cellular reaction.
Immune Response description1 monthThe research will describe and distinguish the type of immune response observed both on the basis of the titers of antibodies (IgG and IgM) produced.

Secondary

MeasureTime frameDescription
Clinical and Immunological Analysis2 monthsthe research will focus on the analysis of the hanges in antibody titers over time as a function of the clinical signs observed at initial diagnosis and the post-COVID-19 symptoms and the possible reinfections.
Comparison of the occurrence of clinical events with other immunological data2 monthsIt will also confront the occurrence of clinical events (post-COVID-19 symptoms and reinfections) with immunological data (antibody levels, cellular immune response) and compare anti-SARS-CoV-2 antibody titers to those determined for other similar viruses (Rubella, Mumps).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026