Immunity and Infections in the Psychiatric Population

COVID Clinical Trial

— COVIDIMMUNOPSY  

Official title:

Immunity and COVID Infections in the Psychiatric Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04381845
• Other study ID #: APHP200553
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2021
• Est. completion date: December 10, 2023

Study information

• Verified date: February 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: France GUYOT
• Phone: 0144841751
• Email: france.guyot[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Infections
• Mental Disorders
• Problem Behavior
• Psychiatric Disorders

Intervention

Diagnostic Test:
• COVID19 immunization testing
serological COVID19 test with confirmation at J15 during hospitalization

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris	Paris	Ile De France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	day 15