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

Sponsor

University Hospital, Lille (Other)

Overall Status

Unknown status

CT.gov ID

NCT04353609

Collaborator

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

13,770

Enrollment

Location

7.5

Anticipated Duration (Months)

1846.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sars-CoV2 Chronic Inflammatory Rheumatism Autoimmune Diseases

Study Design

Study Type:

Observational

Anticipated Enrollment :

13770 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Apr 18, 2020

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Proportion of patients who die from a severe form 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 [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) [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 [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 [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 [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 [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 [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 [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 [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 [Before the set-up of first symptoms of covid-19 (Baseline visit)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

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)