<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04470648</url>
  </required_header>
  <id_info>
    <org_study_id>C20-50</org_study_id>
    <nct_id>NCT04470648</nct_id>
  </id_info>
  <brief_title>COVID-19 Infection at Samusocial in Paris: Descriptive and Serological Survey</brief_title>
  <official_title>COVID-19 Infection at Samusocial in Paris: Descriptive and Serological Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Samusocial de Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study of COVID-19 seroprevalence in precarious population living in shelters of Samusocial de&#xD;
      Paris and in staff working in these centers during COVID-19 epidemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After emergence of a new coronavirus (Severe Acute Respiratory Syndrome Coronavirus 2,&#xD;
      SARS-CoV2) responsible for a cluster of respiratory infection at Wuhan, China, on January,&#xD;
      7th 2020, first cases were diagnosed in France in January 24th 2020.&#xD;
&#xD;
      Health care components of Samusocial de Paris (Lits Haltes Soins Santé (LHSS)) were created&#xD;
      in 2006. They provide medical care for homeless people and people in social distress not&#xD;
      needing an hospitalization. Sometimes there are 3 persons in a bedroom.&#xD;
&#xD;
      In december 2018, a special shelter for isolated women or women in precarious situations&#xD;
      opened.&#xD;
&#xD;
      Because of the living conditions in these centers and the difficulty for these populations to&#xD;
      respect social distancing and hygiene recommendations.&#xD;
&#xD;
      A first case of COVID-19 was identified on March 8th 2020 in one of these healthcare centers.&#xD;
      Other cases were detected in the same center, then in another center on March 16th, then in&#xD;
      the dormitory of the women shelter on March 30th.&#xD;
&#xD;
      A recent study showed an important prevalence of SARS-COV2 in residents of a homeless shelter&#xD;
      in Boston (36%), most of them were asymptomatic.&#xD;
&#xD;
      Seroprevalence studies are done in general population or in health care workers, but don't&#xD;
      include vulnerable people.&#xD;
&#xD;
      It seemed important to us to describe the epidemic in these centers and to study COVID-19&#xD;
      seroprevalence in these particular populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Actual">August 22, 2021</completion_date>
  <primary_completion_date type="Actual">April 8, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SARS-COV-2 seroprevalence in 3 centers for homeless and people in social distress</measure>
    <time_frame>6 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morbidity rate</measure>
    <time_frame>6 months</time_frame>
    <description>Measure of morbidity in the participating population in the 3 centers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Covid-19 related death rate in the 3 centers from March to May 2020</measure>
    <time_frame>6 months</time_frame>
    <description>Number of deaths related to Covid-19 during the epidemic in the 3 centers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of negative serology rate and positive serology rate in the 3 centers</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of SARS-COV2 seroprevalence obtained in these centers to the estimated seroprevalence in the Ile de France region</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>kinetics of SARS-COV2 antibodies in people with initial positive serology</measure>
    <time_frame>10 months</time_frame>
    <description>2 blood tests 4 and 8 months afetr the first one</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">179</enrollment>
  <condition>SARS-COV2 Infection</condition>
  <arm_group>
    <arm_group_label>hosted in the center and HCWs at the epidemic period</arm_group_label>
    <description>people hosted in the health care or in the women center and health care workers working in one these centers during the epidemic time.&#xD;
People with initial positive SARS-COV2 serology will have a second blood test to mesure atibodies kinetic</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>blood test for SARS-COV2 serology</intervention_name>
    <description>each person who will accept to participate will have a bood test for a SARS-COV2 serology</description>
    <arm_group_label>hosted in the center and HCWs at the epidemic period</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood for serology testing&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        people hosted and workers at one these 3 centers during the epidemic time (march to may&#xD;
        2020)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  to have been hosted or working in one the three centers (LHSS Ridder-Plaisance or&#xD;
             Saint Michel or Halte femmes) between march and may 2020&#xD;
&#xD;
          -  to be aged 18 y or more&#xD;
&#xD;
          -  to be able to give an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  people who refuse to participate&#xD;
&#xD;
          -  not being able to give an informed consent&#xD;
&#xD;
          -  Person subject to a legal protection measure (safeguard of justice, curatorship or&#xD;
             guardianship)&#xD;
&#xD;
          -  Person who does not understand the information provided on how to carry out the&#xD;
             research&#xD;
&#xD;
          -  Obstacle to venous sampling&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yazdan Yazdanpanah, MD PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haltes pour femmes</name>
      <address>
        <city>Paris</city>
        <zip>75004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LHSS Saint-Michel</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LHSS Ridder-Plaisance</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Bernard Stoecklin S, Rolland P, Silue Y, Mailles A, Campese C, Simondon A, Mechain M, Meurice L, Nguyen M, Bassi C, Yamani E, Behillil S, Ismael S, Nguyen D, Malvy D, Lescure FX, Georges S, Lazarus C, Tabai A, Stempfelet M, Enouf V, Coignard B, Levy-Bruhl D; Investigation team. First cases of coronavirus disease 2019 (COVID-19) in France: surveillance, investigations and control measures, January 2020. Euro Surveill. 2020 Feb;25(6):2000094. doi: 10.2807/1560-7917.ES.2020.25.6.2000094.</citation>
    <PMID>32070465</PMID>
  </results_reference>
  <results_reference>
    <citation>Lescure FX, Bouadma L, Nguyen D, Parisey M, Wicky PH, Behillil S, Gaymard A, Bouscambert-Duchamp M, Donati F, Le Hingrat Q, Enouf V, Houhou-Fidouh N, Valette M, Mailles A, Lucet JC, Mentre F, Duval X, Descamps D, Malvy D, Timsit JF, Lina B, van-der-Werf S, Yazdanpanah Y. Clinical and virological data of the first cases of COVID-19 in Europe: a case series. Lancet Infect Dis. 2020 Jun;20(6):697-706. doi: 10.1016/S1473-3099(20)30200-0. Epub 2020 Mar 27. Erratum In: Lancet Infect Dis. 2020 May 19;: Lancet Infect Dis. 2020 Jun;20(6):e116.</citation>
    <PMID>32224310</PMID>
  </results_reference>
  <results_reference>
    <citation>Deslandes A, Berti V, Tandjaoui-Lambotte Y, Alloui C, Carbonnelle E, Zahar JR, Brichler S, Cohen Y. SARS-CoV-2 was already spreading in France in late December 2019. Int J Antimicrob Agents. 2020 Jun;55(6):106006. doi: 10.1016/j.ijantimicag.2020.106006. Epub 2020 May 3.</citation>
    <PMID>32371096</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.</citation>
    <PMID>31978945</PMID>
  </results_reference>
  <results_reference>
    <citation>Backer JA, Klinkenberg D, Wallinga J. Incubation period of 2019 novel coronavirus (2019-nCoV) infections among travellers from Wuhan, China, 20-28 January 2020. Euro Surveill. 2020 Feb;25(5):2000062. doi: 10.2807/1560-7917.ES.2020.25.5.2000062.</citation>
    <PMID>32046819</PMID>
  </results_reference>
  <results_reference>
    <citation>Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.</citation>
    <PMID>31995857</PMID>
  </results_reference>
  <results_reference>
    <citation>Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.</citation>
    <PMID>32109013</PMID>
  </results_reference>
  <results_reference>
    <citation>Baggett TP, Keyes H, Sporn N, Gaeta JM. Prevalence of SARS-CoV-2 Infection in Residents of a Large Homeless Shelter in Boston. JAMA. 2020 Jun 2;323(21):2191-2192. doi: 10.1001/jama.2020.6887.</citation>
    <PMID>32338732</PMID>
  </results_reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Seroprevalence</keyword>
  <keyword>SARS-COV2</keyword>
  <keyword>Precarious</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04470648
org study id: C20-50
nct id: NCT04470648
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
measure: SARS-COV-2 seroprevalence in 3 centers for homeless and people in social distress
time frame: 6 months
description: 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
measure: Morbidity rate
time frame: 6 months
description: Measure of morbidity in the participating population in the 3 centers
measure: Covid-19 related death rate in the 3 centers from March to May 2020
time frame: 6 months
description: Number of deaths related to Covid-19 during the epidemic in the 3 centers
measure: Ratio of negative serology rate and positive serology rate in the 3 centers
time frame: 6 months
measure: Ratio of SARS-COV2 seroprevalence obtained in these centers to the estimated seroprevalence in the Ile de France region
time frame: 6 months
measure: kinetics of SARS-COV2 antibodies in people with initial positive serology
time frame: 10 months
description: 2 blood tests 4 and 8 months afetr the first one
arm group label: hosted in the center and HCWs at the epidemic period
description: 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
intervention type: Diagnostic Test
intervention name: blood test for SARS-COV2 serology
description: each person who will accept to participate will have a bood test for a SARS-COV2 serology
arm group label: hosted in the center and HCWs at the epidemic period
blood for serology testing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yazdan Yazdanpanah, MD PHD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
facility: 
facility: 
country: France
citation: Bernard Stoecklin S, Rolland P, Silue Y, Mailles A, Campese C, Simondon A, Mechain M, Meurice L, Nguyen M, Bassi C, Yamani E, Behillil S, Ismael S, Nguyen D, Malvy D, Lescure FX, Georges S, Lazarus C, Tabai A, Stempfelet M, Enouf V, Coignard B, Levy-Bruhl D; Investigation team. First cases of coronavirus disease 2019 (COVID-19) in France: surveillance, investigations and control measures, January 2020. Euro Surveill. 2020 Feb;25(6):2000094. doi: 10.2807/1560-7917.ES.2020.25.6.2000094.
PMID: 32070465
citation: Lescure FX, Bouadma L, Nguyen D, Parisey M, Wicky PH, Behillil S, Gaymard A, Bouscambert-Duchamp M, Donati F, Le Hingrat Q, Enouf V, Houhou-Fidouh N, Valette M, Mailles A, Lucet JC, Mentre F, Duval X, Descamps D, Malvy D, Timsit JF, Lina B, van-der-Werf S, Yazdanpanah Y. Clinical and virological data of the first cases of COVID-19 in Europe: a case series. Lancet Infect Dis. 2020 Jun;20(6):697-706. doi: 10.1016/S1473-3099(20)30200-0. Epub 2020 Mar 27. Erratum In: Lancet Infect Dis. 2020 May 19;: Lancet Infect Dis. 2020 Jun;20(6):e116.
PMID: 32224310
citation: Deslandes A, Berti V, Tandjaoui-Lambotte Y, Alloui C, Carbonnelle E, Zahar JR, Brichler S, Cohen Y. SARS-CoV-2 was already spreading in France in late December 2019. Int J Antimicrob Agents. 2020 Jun;55(6):106006. doi: 10.1016/j.ijantimicag.2020.106006. Epub 2020 May 3.
PMID: 32371096
citation: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
PMID: 31978945
citation: Backer JA, Klinkenberg D, Wallinga J. Incubation period of 2019 novel coronavirus (2019-nCoV) infections among travellers from Wuhan, China, 20-28 January 2020. Euro Surveill. 2020 Feb;25(5):2000062. doi: 10.2807/1560-7917.ES.2020.25.5.2000062.
PMID: 32046819
citation: Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
PMID: 31995857
citation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PMID: 32109013
citation: Baggett TP, Keyes H, Sporn N, Gaeta JM. Prevalence of SARS-CoV-2 Infection in Residents of a Large Homeless Shelter in Boston. JAMA. 2020 Jun 2;323(21):2191-2192. doi: 10.1001/jama.2020.6887.
PMID: 32338732
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19