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TerminatedNCT04510467MentCovid19RMDUpdated Jan 13, 2023

Mental Health Consequences of COVID19 Infection in the French RMD Cohort

An observational study in Covid19, Systemic Autoimmune Disease and Inflammatory Rheumatism, sponsored by University Hospital, Lille. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-13.

Sponsored by University Hospital, Lille · Observational

Why this study was terminated
inclusion number not reached during the period
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
296
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Covid19
  • Systemic Autoimmune Disease
  • Inflammatory Rheumatism
  • Auto Inflammatory Diseases
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 296 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

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

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
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
296 participants (actual)
Patient registry
No

Groups and cohorts

  • case group

    RMD patients with COVID 19 infection

  • control group

    RMD patients without COVID 19 infection

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What researchers measure

Primary outcomes

  1. Frequency of PTSD depending on whether or not autoimmune patients have experienced COVID

    Time frame: at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection

Secondary outcomes

  1. Severity of PTSD depending on whether or not autoimmune patients have experienced COVID

    Time frame: at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection

07

Study locations

1 site
  • Hop Claude Huriez Chu Lille
    Lille, 59037, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04510467
Lead sponsor
University Hospital, Lille
Collaborators
FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
Responsible party
Sponsor
First posted
Aug 12, 2020
Start date
Jan 20, 2021
Primary completion
May 19, 2022
Completion
May 19, 2022
Last update
Jan 13, 2023

Study contacts

Eric Hachulla, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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