Immunity and Infections in the Psychiatric Population

Not Applicable

Recruiting

• Conditions: Psychiatric Disorders; COVID
• Interventions: Diagnostic Test: COVID19 immunization testing

• Registration Number: NCT04381845
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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:

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

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 Timeline

• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-11
• Study Start: 2021-01-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15
• Primary Completion: 2023-12-10
• Study Completion: 2023-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
psychiatric patient	COVID19 immunization testing	patients who are hospitalized in psychiatric department

Primary Outcome Measures

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

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Paris; 🇫🇷 Paris, Ile De France, France