NCT04381845

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

January 10, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

May 15, 2023

Status Verified

February 1, 2023

Enrollment Period

2.9 years

First QC Date

May 6, 2020

Last Update Submit

May 12, 2023

Conditions

COVIDPsychiatric Disorders

Keywords

COVID infectionpsychiatric population

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

psychiatric patient

OTHER

patients who are hospitalized in psychiatric department

Diagnostic Test: COVID19 immunization testing

Interventions

COVID19 immunization testingDIAGNOSTIC_TEST

serological COVID19 test with confirmation at J15 during hospitalization

psychiatric patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient
  • Signed informed consent

You may not qualify if:

  • Inability to obtain the consent of the patient or legal representative, if applicable
  • Patient under safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris

Paris, Île-de-France Region, France

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Marion LEBOYER, PHD

    Assistance Publique des Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

France GUYOT

CONTACT

0144841751france.guyot@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 11, 2020

Study Start

January 10, 2021

Primary Completion

December 10, 2023

Study Completion

December 10, 2023

Last Updated

May 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)