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NCT04381845 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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