NCT04470648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

July 22, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2021

Completed
Last Updated

January 26, 2026

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

July 12, 2020

Last Update Submit

January 23, 2026

Conditions

Keywords

SeroprevalenceSARS-COV2Precarious

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (5)

  • Morbidity rate

    6 months

  • Covid-19 related death rate in the 3 centers from March to May 2020

    6 months

  • 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

Study Arms (1)

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

Interventions

each person who will accept to participate will have a bood test for a SARS-COV2 serology

hosted in the center and HCWs at the epidemic period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Haltes pour femmes

Paris, 75004, France

Location

LHSS Saint-Michel

Paris, 75012, France

Location

LHSS Ridder-Plaisance

Paris, 75014, France

Location

Related Publications (9)

  • 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: 32070465BACKGROUND
  • 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.

    PMID: 32224310BACKGROUND
  • 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: 32371096BACKGROUND
  • 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: 31978945BACKGROUND
  • 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: 32046819BACKGROUND
  • 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: 31995857BACKGROUND
  • 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: 32109013BACKGROUND
  • 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: 32338732BACKGROUND
  • Husain M, Rachline A, Cousien A, Rolland S, Rouzaud C, Ferre VM, Gomez MV, Le Teurnier M, Wicky-Thisse M, Descamps D, Yazdanpanah Y, Charpentier C, Pasquet-Cadre A. Impact of the COVID-19 pandemic on the homeless: results from a retrospective closed cohort in France (March-May 2020). Clin Microbiol Infect. 2021 Oct;27(10):1520.e1-1520.e5. doi: 10.1016/j.cmi.2021.05.039. Epub 2021 Jun 7.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood for serology testing

MeSH Terms

Conditions

COVID-19

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Yazdan Yazdanpanah, MD PHD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2020

First Posted

July 14, 2020

Study Start

July 22, 2020

Primary Completion

April 8, 2021

Study Completion

August 22, 2021

Last Updated

January 26, 2026

Record last verified: 2023-02

Locations