Immunity and Infections in the Psychiatric Population (COVIDIMMUNOPSY)

May 12, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Immunity and COVID Infections in the Psychiatric Population

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:

  1. Clinically characterize COVID patients who are positive for serological testing
  2. Assess the socio-demographic, clinical and psychotropic determinants of a COVID diagnosis
  3. Immunologically characterize COVID patients who are positive for serological testing
  4. Exploring the links between susceptibility to COVID19 and erythrocytic blood groups

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: psychiatric patient
patients who are hospitalized in psychiatric department
Diagnostic test: COVID19 immunization testing
serological COVID19 test with confirmation at J15 during hospitalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of COVID-positive patients
Time Frame: day 15
Number of COVID-positive patients, defined by a positive serological test result by immuno-chromatography at inclusion or at 15 days.
day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Marion LEBOYER, PHD, Assistance publique des Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2021

Primary Completion (Anticipated)

December 10, 2023

Study Completion (Anticipated)

December 10, 2023

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP200553

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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