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Immunity and Infections in the Psychiatric Population (COVIDIMMUNOPSY)

Primary Purpose

COVID, Psychiatric Disorders

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
COVID19 immunization testing
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID focused on measuring COVID infection, psychiatric population

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patient
  • Hospitalized in one of the participating psychiatric wards during the inclusion period
  • Signed informed consent

Exclusion Criteria:

  • Inability to obtain the consent of the patient or legal representative, if applicable
  • Patient under safeguard of justice

Sites / Locations

  • Assistance Publique - Hôpitaux de ParisRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

psychiatric patient

Arm Description

patients who are hospitalized in psychiatric department

Outcomes

Primary Outcome Measures

Number of COVID-positive patients
Number of COVID-positive patients, defined by a positive serological test result by immuno-chromatography at inclusion or at 15 days.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2020
Last Updated
May 12, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT04381845
Brief Title
Immunity and Infections in the Psychiatric Population
Acronym
COVIDIMMUNOPSY
Official Title
Immunity and COVID Infections in the Psychiatric Population
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this multicenter cohort study is to determine the degree of COVID19 infection immunization of a population of psychiatric patients. The secondary objective of this cohort follow-up is to: Clinically characterize COVID patients who are positive for serological testing Assess the socio-demographic, clinical and psychotropic determinants of a COVID diagnosis Immunologically characterize COVID patients who are positive for serological testing Exploring the links between susceptibility to COVID19 and erythrocytic blood groups
Detailed Description
All patients accepting to participate will be included in participating psychiatry services and will have a COVID Serological Test for Inclusion with confirmation at J15 including immune-genetics data. A Comparison of COVID patients versus no COVID patients will be based on a clinical examination (psychiatric, somatic) and blood samples collected at J0 and J15.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Psychiatric Disorders
Keywords
COVID infection, psychiatric population

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
psychiatric patient
Arm Type
Other
Arm Description
patients who are hospitalized in psychiatric department
Intervention Type
Diagnostic Test
Intervention Name(s)
COVID19 immunization testing
Intervention Description
serological COVID19 test with confirmation at J15 during hospitalization
Primary Outcome Measure Information:
Title
Number of COVID-positive patients
Description
Number of COVID-positive patients, defined by a positive serological test result by immuno-chromatography at inclusion or at 15 days.
Time Frame
day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patient Hospitalized in one of the participating psychiatric wards during the inclusion period Signed informed consent Exclusion Criteria: Inability to obtain the consent of the patient or legal representative, if applicable Patient under safeguard of justice
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
France GUYOT
Phone
0144841751
Ext
33
Email
france.guyot@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion LEBOYER, PHD
Organizational Affiliation
Assistance Publique des Hopitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Paris
City
Paris
State/Province
Ile De France
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Vivaldo
Email
isabelle.vivaldo@aphp.fr
First Name & Middle Initial & Last Name & Degree
Pierre-André Natella, PharmD
Email
pierre.natella@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Immunity and Infections in the Psychiatric Population

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