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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04353609
Acronym
covid19 fai2r
Enrollment
13770
Registered
2020-04-20
Start date
2020-04-18
Completion date
2020-12-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases, Chronic Inflammatory Rheumatism, Sars-CoV2

Keywords

Covid-19, chronic inflammatory rheumatism, auto-immune diseases, auto-inflammatory diseases, intensive care unit

Brief summary

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.

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER
FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

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

Design outcomes

Primary

MeasureTime frame
Proportion of patients presenting a severe form of covid-19 requiring an intensive care unit admission or leading to deathFrom Baseline up to Day 21 after first symptoms of covid-19

Secondary

MeasureTime frame
Proportion of patients who die from a severe form of covid-19From Baseline up to Day 21 after first symptoms of covid-19
Proportion of patients who present an history of diabetes according to medical recordsBefore 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)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 recordsBefore the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present an history of Asthma according to medical recordsBefore the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present an history of Hypertension according to medical recordsBefore the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present an history of cardiac disease according to medical recordsBefore 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 recordsBefore the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present an history of stroke according to medical recordsBefore 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 recordsBefore the set-up of first symptoms of covid-19 (Baseline visit)
Proportion of patients who present an history of cancer according to medical recordsBefore the set-up of first symptoms of covid-19 (Baseline visit)

Countries

France

Contacts

PRINCIPAL_INVESTIGATOREric Hachulla, MD,PhD

University Hospital, Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026