Immunity and Infections in the Psychiatric Population | NCT04381845

Studies
Immunity and Infections in the Psychiatric Population

NCT04381845

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

May 15, 2023Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

COVID
Psychiatric Disorders

Interventions

COVID19 immunization testing

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2021Actual

Primary Completion Date

Dec 10, 2023Estimated

Completion Date

Dec 10, 2023Estimated

First Submitted Date

May 6, 2020

First Submission Date that Met QC Criteria

May 6, 2020

First Posted Date

May 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2023

Last Update Posted Date

May 15, 2023Actual

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Clinically characterize COVID patients who are positive for serological testing
Assess the socio-demographic, clinical and psychotropic determinants of a COVID diagnosis
Immunologically characterize COVID patients who are positive for serological testing
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
psychiatric patient	Other	patients who are hospitalized in psychiatric department	Diagnostic Test: COVID19 immunization testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVID19 immunization testing	Diagnostic Test	serological COVID19 test with confirmation at J15 during hospitalization	psychiatric patient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
France GUYOT	Contact	0144841751	33	france.guyot@aphp.fr

Overall Officials

Name	Affiliation	Role
Marion LEBOYER, PHD	Assistance Publique des Hopitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique - Hôpitaux de Paris	Recruiting	Paris	Île-de-France Region		France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001523	Mental Disorders

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided