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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT04470648

Collaborator

Samusocial de Paris (Other), Assistance Publique - Hôpitaux de Paris (Other)

183

Enrollment

Locations

12.3

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-COV2 Infection	Diagnostic Test: blood test for SARS-COV2 serology

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 Design

Study Type:

Observational

Anticipated Enrollment :

183 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 22, 2020

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

SARS-COV-2 seroprevalence in 3 centers for homeless and people in social distress [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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