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

Autoimmune Diseases Clinical Trial

— covid19 fai2r  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04353609
• Other study ID #: NI_2020_03
• Status: Recruiting
• Start date: April 18, 2020
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Lille
• Contact: Eric Hachulla, MD,PhD
• Phone: 320445962
• Email: covid19.fai2r[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13770
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Chronic Inflammatory Rheumatism
• Collagen Diseases
• Rheumatic Diseases
• Rheumatic Fever
• Sars-CoV2

Locations

Country	Name	City	State
France	Hôpital Huriez	Lille

Sponsors (2)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients presenting a severe form of covid-19 requiring an intensive care unit admission or leading to death		From Baseline up to Day 21 after first symptoms of covid-19
Secondary	Proportion of patients who die from a severe form of covid-19		From Baseline up to Day 21 after first symptoms of covid-19
Secondary	Proportion of patients who present an history of diabetes according to medical records		Before the set-up of first symptoms of covid-19 (Baseline visit)
Secondary	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)
Secondary	Proportion of patients who present an history of Chronic Pulmonary Obstructive Disease according to medical records		Before the set-up of first symptoms of covid-19 (Baseline visit)
Secondary	Proportion of patients who present an history of Asthma according to medical records		Before the set-up of first symptoms of covid-19 (Baseline visit)
Secondary	Proportion of patients who present an history of Hypertension according to medical records		Before the set-up of first symptoms of covid-19 (Baseline visit)
Secondary	Proportion of patients who present an history of cardiac disease according to medical records		Before the set-up of first symptoms of covid-19 (Baseline visit)
Secondary	Proportion of patients who present an history of Pulmonary Interstitial Disease according to medical records		Before the set-up of first symptoms of covid-19 (Baseline visit)
Secondary	Proportion of patients who present an history of stroke according to medical records		Before the set-up of first symptoms of covid-19 (Baseline visit)
Secondary	Proportion of patients who present an history of angiotensin-converting-enzyme inhibitor according to medical records		Before the set-up of first symptoms of covid-19 (Baseline visit)
Secondary	Proportion of patients who present an history of cancer according to medical records		Before the set-up of first symptoms of covid-19 (Baseline visit)