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

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ClinicalTrials.gov Identifier: NCT04470648
Recruitment Status : Not yet recruiting
First Posted : July 14, 2020
Last Update Posted : July 21, 2020
Sponsor:
Collaborators:
Samusocial de Paris
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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
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.

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: COVID-19 Infection at Samusocial in Paris: Descriptive and Serological Survey
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Morbidity rate [ Time Frame: 6 months ]
    Measure of morbidity in the participating population in the 3 centers

  2. 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

  3. Ratio of negative serology rate and positive serology rate in the 3 centers [ Time Frame: 6 months ]
  4. Ratio of SARS-COV2 seroprevalence obtained in these centers to the estimated seroprevalence in the Ile de France region [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
blood for serology testing


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
people hosted and workers at one these 3 centers during the epidemic time (march to may 2020)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470648


Contacts
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Contact: Yazdan Yazdanpanah, MD PHD +33140257803 yazdan.yazdanpanah@aphp.fr
Contact: Anne Rachline, MD +33140257803 anne.rachline@aphp.fr

Locations
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France
Haltes pour femmes
Paris, France, 75004
Contact: Armelle Pasquet, MD       a.pasquet@samusocial-75.fr   
LHSS Saint-Michel
Paris, France, 75012
Contact: Armelle Pasquet, MD       a.pasquet@samusocial-75.fr   
LHSS Ridder-Plaisance
Paris, France, 75014
Contact: Armelle Pasquet, MD       a.pasquet@samusocial-75.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Samusocial de Paris
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Yazdan Yazdanpanah, MD PHD Assistance Publique - Hôpitaux de Paris
Publications of Results:

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT04470648    
Other Study ID Numbers: C20-50
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Seroprevalence
SARS-COV2
Precarious
Additional relevant MeSH terms:
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Infection
Communicable Diseases