Assessment of SARS-CoV-2 Seroprevalence in Detention

NCT04516512 | Completed DMC

• 1 other identifier: APHP200667
• Study Type: interventional
• Target: 1,044
• Locations: 1 country
• Sites: 1

Brief Summary

"Background France counted on January 1, 2020, 70,651 people detained, for 61,080 places. Overcrowding in detention is considered as risk factor for infectious diseases transmission, such as respiratory infections. The prison environment represents a confined environment, which could protect prisoners from possible external contamination. If one or more inmates were infected through visiting rooms, officers working in detention, or newly incarcerated people, an epidemic could spread more quickly in the prison community. Thus, few cases of COVID-19 were observed among the subjects in detention with a few weeks delay compared to the free world. However, detention conditions make it more difficult to detect suspicious cases. On the other hand, carrying out diagnostic tests is structurally more difficult to carry out there. Thus, given the plurality of clinical presentations, the non-optimal sensitivity of the SARS-CoV-2 RT-PCR, and the difficulty in carrying out diagnostic tests, it is today difficult to have a precise idea of the number of prisoners having encountered SARS-CoV-2. It is also a population that is not taken into account in the large seroprevalence studies currently conducted in the general population. In order to estimate the number of prisoners exposed to SARS-CoV-2 and in the absence of data currently available in the medical literature, a seroprevalence study in this at risk and little studied population would bring new data to the medical community. Hypothesis In adult subjects living in penal establishments in Ile de France, the seroprevalence of SARS-CoV-2 would be lower compared to the general population. Material and method Open multicenter cross-sectional study carried out in the 11 penal establishments of Ile de France. A sampling of 3,500 inmates stratified over the 16 detention areas concerned will be carried out. The inclusion criteria will be detained subjects who have expressed their consent to participate in the research, aged 18 to 80 years. Each selected detainee will be invited to the health unit to perform a venous blood test for anti-SARS-CoV-2 antibodies. The goal is to take 2,500 blood samples (30% expected refusal rate). Each sample will be analyzed in the virology laboratory at P. Brousse hospital. Expected results Obtain an assessment of the seroprevalence of SARS-CoV-2 in prisons to determine the exposure of detained persons. This assessment will make it possible to undertake public health actions and to propose the implementation of group protection measures such as vaccination if this is soon available.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; inmates; seroprevalence

Outcome Measures

Primary Outcomes (1)

• Determination of the immunological parameters (Immunoglobins G) of the SARS-CoV-2 infection

  It's obtained from ELISA tests carried out on blood samples. A subject will be considered to have been infected with the SARS-CoV-2 virus if anti-SARS-CoV-2 IgGs are detected in his blood sample.

  7 days

Secondary Outcomes (2)

• Symptoms suggestive of COVID-19

  7 days

• Factors assumed to be related to infection with SARS-CoV-2 and the occurrence of moderate to severe forms of COVID-19

  7 days

Study Arms (1)

Investigated arm

EXPERIMENTAL

Participants included in the study who met inclusion criteria

Biological: Blood draw

Interventions

Blood draw BIOLOGICAL

For each participants to the research a peripherical blood draw will be performed

Investigated arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Detained woman appearing on the lists supplied by the penitentiary establishments or detained man drawn by lot from the lists supplied by the penitentiary establishments.
• Age from 18 to 80 years old.
• Free and informed consent signed."

You may not qualify if:

• Subject likely not to respect the terms of the study
• Persons who are placed under legal protection
• Person released from detention between the day of selection and the day of the planned consultation
• Patient who do not speaking French and are not accompanied by a translator
• Pregnant and lactating women

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

USMP

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Guillaume Mellon, MD,MPH

  Etablissement Public de Santé National de Fresnes, Service de Médecine

  STUDY DIRECTOR

• Anne Maie Roque-Afonso, MD, MPH

  Hôpital Paul Brousse, Service de Virologie

  STUDY CHAIR

• Anne Dulioust, MD, PhD

  Etablissement Public national de Fresnes, Service de Médecine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 18, 2020
• Study Start: January 14, 2021
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

FR (1)