Clinical trial NCT04470648: COVID-19 Infection at Samusocial in Paris: Descriptive and Serological Survey
Official title: COVID-19 Infection at Samusocial in Paris: Descriptive and Serological Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-COV2 Infection
Keywords: Seroprevalence
SARS-COV2
Precarious
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Samusocial de Paris
name: Assistance Publique - Hôpitaux de Paris
First posted: 2020-07-14
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people hosted and workers at one these 3 centers during the epidemic time (march to may 2020)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: SARS-COV-2 seroprevalence in 3 centers for homeless and people in social distress
timeFrame: 6 months
Secondary outcomes:
measure: Morbidity rate
timeFrame: 6 months
measure: Covid-19 related death rate in the 3 centers from March to May 2020
timeFrame: 6 months
measure: Ratio of negative serology rate and positive serology rate in the 3 centers
timeFrame: 6 months
measure: Ratio of SARS-COV2 seroprevalence obtained in these centers to the estimated seroprevalence in the Ile de France region
timeFrame: 6 months
measure: kinetics of SARS-COV2 antibodies in people with initial positive serology
timeFrame: 10 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Haltes pour femmes
city: Paris
country: France
facility: LHSS Saint-Michel
city: Paris
country: France
facility: LHSS Ridder-Plaisance
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Yazdan Yazdanpanah, MD PHD
role: PRINCIPAL_INVESTIGATOR
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