COVID-19 Infection at Samusocial in Paris: Descriptive and Serological Survey

February 28, 2023 updated by: Institut National de la Santé Et de la Recherche Médicale, France
Study of COVID-19 seroprevalence in precarious population living in shelters of Samusocial de Paris and in staff working in these centers during COVID-19 epidemic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After emergence of a new coronavirus (Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV2) responsible for a cluster of respiratory infection at Wuhan, China, on January, 7th 2020, first cases were diagnosed in France in January 24th 2020.

Health care components of Samusocial de Paris (Lits Haltes Soins Santé (LHSS)) were created in 2006. They provide medical care for homeless people and people in social distress not needing an hospitalization. Sometimes there are 3 persons in a bedroom.

In december 2018, a special shelter for isolated women or women in precarious situations opened.

Because of the living conditions in these centers and the difficulty for these populations to respect social distancing and hygiene recommendations.

A first case of COVID-19 was identified on March 8th 2020 in one of these healthcare centers. Other cases were detected in the same center, then in another center on March 16th, then in the dormitory of the women shelter on March 30th.

A recent study showed an important prevalence of SARS-COV2 in residents of a homeless shelter in Boston (36%), most of them were asymptomatic.

Seroprevalence studies are done in general population or in health care workers, but don't include vulnerable people.

It seemed important to us to describe the epidemic in these centers and to study COVID-19 seroprevalence in these particular populations.

Study Type

Observational

Enrollment (Actual)

179

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75004
        • Haltes pour femmes
      • Paris, France, 75012
        • LHSS Saint-Michel
      • Paris, France, 75014
        • LHSS Ridder-Plaisance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

people hosted and workers at one these 3 centers during the epidemic time (march to may 2020)

Description

Inclusion Criteria:

  • to have been hosted or working in one the three centers (LHSS Ridder-Plaisance or Saint Michel or Halte femmes) between march and may 2020
  • to be aged 18 y or more
  • to be able to give an informed consent

Exclusion Criteria:

  • people who refuse to participate
  • not being able to give an informed consent
  • Person subject to a legal protection measure (safeguard of justice, curatorship or guardianship)
  • Person who does not understand the information provided on how to carry out the research
  • Obstacle to venous sampling

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hosted in the center and HCWs at the epidemic period

people hosted in the health care or in the women center and health care workers working in one these centers during the epidemic time.

People with initial positive SARS-COV2 serology will have a second blood test to mesure atibodies kinetic
Diagnostic test: blood test for SARS-COV2 serology
each person who will accept to participate will have a bood test for a SARS-COV2 serology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-COV-2 seroprevalence in 3 centers for homeless and people in social distress
Time Frame: 6 months
Primary objective is to evaluate SARS-COV2 seroprevalence in people hosted and health care workers of 3 centers of Samusocial de Paris where COVID19 epidemics occured
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity rate
Time Frame: 6 months
Measure of morbidity in the participating population in the 3 centers
6 months
Covid-19 related death rate in the 3 centers from March to May 2020
Time Frame: 6 months
Number of deaths related to Covid-19 during the epidemic in the 3 centers
6 months
Ratio of negative serology rate and positive serology rate in the 3 centers
Time Frame: 6 months
6 months
Ratio of SARS-COV2 seroprevalence obtained in these centers to the estimated seroprevalence in the Ile de France region
Time Frame: 6 months
6 months
kinetics of SARS-COV2 antibodies in people with initial positive serology
Time Frame: 10 months
2 blood tests 4 and 8 months afetr the first one
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Assistance Publique - Hôpitaux de Paris
Samusocial de Paris

Investigators

  • Principal Investigator: Yazdan Yazdanpanah, MD PHD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2020

Primary Completion (Actual)

April 8, 2021

Study Completion (Actual)

August 22, 2021

Study Registration Dates

First Submitted

July 12, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C20-50

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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