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

SARS-COV2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04470648
• Other study ID #: C20-50
• Status: Completed
• Start date: July 22, 2020
• Est. completion date: August 22, 2021

Study information

• Verified date: February 2023
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: August 22, 2021
• Est. primary completion date: April 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• SARS-COV2 Infection

Intervention

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

Locations

Country	Name	City	State
France	Haltes pour femmes	Paris
France	LHSS Ridder-Plaisance	Paris
France	LHSS Saint-Michel	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Assistance Publique - Hôpitaux de Paris, Samusocial de Paris

Country where clinical trial is conducted

France, 

References & Publications (8)

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. — View 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. — View 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 — View 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. E — View 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 — View 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 — View 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, — View 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 — View Citation

Outcome

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