Immunity and Infections in the Psychiatric Population

NCT ID: NCT04381845

Last Updated: 2023-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-10

Study Completion Date

2023-12-10

Brief Summary

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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

Detailed Description

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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.

Conditions

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COVID Psychiatric Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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psychiatric patient

patients who are hospitalized in psychiatric department

Group Type OTHER

COVID19 immunization testing

Intervention Type DIAGNOSTIC_TEST

serological COVID19 test with confirmation at J15 during hospitalization

Interventions

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COVID19 immunization testing

serological COVID19 test with confirmation at J15 during hospitalization

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marion LEBOYER, PHD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique des Hopitaux de Paris

Locations

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Assistance Publique - Hôpitaux de Paris

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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France GUYOT

Role: CONTACT

0144841751 ext. 33

Facility Contacts

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Isabelle Vivaldo

Role: primary

Pierre-André Natella, PharmD

Role: backup

Other Identifiers

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APHP200553

Identifier Type: -

Identifier Source: org_study_id

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