Mental Health Consequences of COVID19 Infection in the Fr... | NCT04510467

Studies
Mental Health Consequences of COVID19 Infection in the French RMD Cohort

NCT04510467

Sponsor

University Hospital, Lille

Status

Terminated

Last Update Posted

Jan 13, 2023Actual

Enrollment

296Actual

Phase

Not provided

Conditions

Covid19
Systemic Autoimmune Disease
Inflammatory Rheumatism
Auto Inflammatory Diseases

Interventions

Not provided

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

ID	Type	Description	Link
2020-A02058-31	Other Identifier	ID-RCB number,ANSM

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inclusion number not reached during the period

Expanded Access Info

Start Date

Jan 20, 2021Actual

Primary Completion Date

May 19, 2022Actual

Completion Date

May 19, 2022Actual

First Submitted Date

Aug 11, 2020

First Submission Date that Met QC Criteria

Aug 11, 2020

First Posted Date

Aug 12, 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

Jan 11, 2023

Last Update Posted Date

Jan 13, 2023Actual

Name	Class
FAI²R (Auto-immune and auto-inflammatory rare diseases French network)	UNKNOWN

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

this observational, cross-sectional, national, comparative study, including RMD patients followed in hospital centres of the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners caring for patients suffering from inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases. The objective of the study is to compare RMD patients with COVID 19 infection (cases) to RMD patients who have not had COVID 19 infection (controls) on their mental health.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

296Actual

Label	Type	Description	Intervention Names
case group		RMD patients with COVID 19 infection
control group		RMD patients without COVID 19 infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of PTSD depending on whether or not autoimmune patients have experienced COVID		at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection

Secondary Outcomes

Measure	Description	Time Frame
Severity of PTSD depending on whether or not autoimmune patients have experienced COVID		at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient case:

Patient with inflammatory rheumatism, systemic autoimmune or autoimmune disease
With confirmed COVID-19 infection (at least one month prior to study inclusion)
Study information given to the patient
Patient affiliated to social security

Patient control:

Patient with inflammatory rheumatism, systemic autoimmune disease or autoimmune disease.
Not having had a confirmed COVID-19 infection
Study information given to the patient
Patient affiliated to social security

Exclusion Criteria:

Opposition to participation in the study by the patient and/or his legal representative
Adult patient not able to understand the implications and rules of the study
Protected adults under guardianship or curatorship

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

Patients will be recruited from the French RMD covid19 cohort (ClinicalTrials.gov Identifier: NCT04353609) including patients from hospitals in the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners (rheumatologists, internists with mixed hospital and private practice activities) caring for patients with inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases.

Sampling Method

Probability Sample

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

ID	Term
D000086382	COVID-19
D012213	Rheumatic Fever