Covid-19 in Patients With Chronic Inflammatory Rheumatism, Auto-immune or Auto-inflammatory Rare and Non-rare Diseases (covid19 fai2r)

May 21, 2026 updated by: University Hospital, Lille

Covid-19 in Patients With Chronic Inflammatory Rheumatism, Auto-immune or Auto-inflammatory Rare and Non-rare Diseases : a Retrospective Multicenter Observational Study

Since December 2019, an international outbreak of respiratory illnesses caused by SARS-CoV-2 called covid-19 has become a global challenge. In France, while the first cases were reported in January, more than 20 000 cases were confirmed at end of March. Early estimations from epidemiological data seem to show that 18-20% of patients with confirmed covid-19 are admitted in an intensive care unit (ICU). Patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases are susceptible to severe covid-19 (i.e ICU) due to the specific therapeutic management of their illness (corticosteroid, immunosuppressive and immunomodulatory drugs,..). No data are available for this particular population in France.

This retrospective multicentre observational study aims to evaluate the frequency of severe forms of covid-19 and risk factors associated with specific outcomes in covid-19 in patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

13770

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Hôpital Huriez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases with proven SARS-Cov-2 infection (COVID-19) taken care in hospital or in private practice by rheumatologist, internist or pediatrician working in both hospital and private practice activities

Description

Inclusion Criteria:

  • All patients, children and adults
  • Patients with known chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases with proven/suspected SARS-Cov-2 infection (COVID-19) (by biological data (serological or positive Cov-2 PCR) or CT scan images or clinical observations consistent with covid-19)

Exclusion Criteria:

  • patients opposed to the use of their data
  • patients under guardianship, protected persons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients presenting a severe form of covid-19 requiring an intensive care unit admission or leading to death
Time Frame: From Baseline up to Day 21 after first symptoms of covid-19
From Baseline up to Day 21 after first symptoms of covid-19

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients who die from a severe form of covid-19
Time Frame: From Baseline up to Day 21 after first symptoms of covid-19
From Baseline up to Day 21 after first symptoms of covid-19
Proportion of patients who present an history of diabetes according to medical records
Time Frame: Before the set-up of first symptoms of covid-19 (Baseline visit)
Before the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present obesity (validated by Body Mass Index value > 30 kg/cm2)
Time Frame: At the set-up of first symptoms of covid-19 (Baseline visit)
At the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present an history of Chronic Pulmonary Obstructive Disease according to medical records
Time Frame: Before the set-up of first symptoms of covid-19 (Baseline visit)
Before the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present an history of Asthma according to medical records
Time Frame: Before the set-up of first symptoms of covid-19 (Baseline visit)
Before the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present an history of Hypertension according to medical records
Time Frame: Before the set-up of first symptoms of covid-19 (Baseline visit)
Before the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present an history of cardiac disease according to medical records
Time Frame: Before the set-up of first symptoms of covid-19 (Baseline visit)
Before the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present an history of Pulmonary Interstitial Disease according to medical records
Time Frame: Before the set-up of first symptoms of covid-19 (Baseline visit)
Before the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present an history of stroke according to medical records
Time Frame: Before the set-up of first symptoms of covid-19 (Baseline visit)
Before the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present an history of angiotensin-converting-enzyme inhibitor according to medical records
Time Frame: Before the set-up of first symptoms of covid-19 (Baseline visit)
Before the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present an history of cancer according to medical records
Time Frame: Before the set-up of first symptoms of covid-19 (Baseline visit)
Before the set-up of first symptoms of covid-19 (Baseline visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

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

Investigators

  • Principal Investigator: Eric Hachulla, MD,PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI_2020_03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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