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

NCT04353609 | Unknown

• 1 other identifier: NI_2020_03
• Study Type: observational
• Target: 13,770
• Locations: 1 country
• Sites: 1

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.

Conditions

Sars-CoV2; Chronic Inflammatory Rheumatism; Autoimmune Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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)

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead
• FAI²R (Auto-immune and auto-inflammatory rare diseases French network): collaborator

Study Sites (1)

Hôpital Huriez

Lille, 59037, France

RECRUITING

Related Publications (4)

• Perrot L, Boyer L, Flipo RM, Marotte H, Pertuiset E, Miceli C, Thomas T, Seror R, Chazerain P, Roux N, Richez C, Pham T; FAI2R/SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium. Factors associated with COVID-19 severity in patients with spondyloarthritis: Results of the French RMD COVID-19 cohort. Joint Bone Spine. 2023 Dec;90(6):105608. doi: 10.1016/j.jbspin.2023.105608. Epub 2023 Jul 5.

  PMID: 37414137 DERIVED

• Truchetet ME, Drumez E, Barnetche T, Martin C, Devaux M, Goulenok T, Maria A, Schmidt J, Abdallah NA, Melki I, Hachulla E, Richez C. Outcome of COVID-19 in patients with rheumatic and inflammatory diseases treated with mycophenolic acid: data from the French RMD COVID-19 cohort. RMD Open. 2022 Sep;8(2):e002476. doi: 10.1136/rmdopen-2022-002476.

  PMID: 36113962 DERIVED

• Avouac J, Drumez E, Hachulla E, Seror R, Georgin-Lavialle S, El Mahou S, Pertuiset E, Pham T, Marotte H, Servettaz A, Domont F, Chazerain P, Devaux M, Claudepierre P, Langlois V, Mekinian A, Maria ATJ, Banneville B, Fautrel B, Pouchot J, Thomas T, Flipo RM, Richez C; FAI2R/SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors; FAIR/SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors. COVID-19 outcomes in patients with inflammatory rheumatic and musculoskeletal diseases treated with rituximab: a cohort study. Lancet Rheumatol. 2021 Jun;3(6):e419-e426. doi: 10.1016/S2665-9913(21)00059-X. Epub 2021 Mar 25.

  PMID: 33786454 DERIVED

• FAI2R /SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors. Severity of COVID-19 and survival in patients with rheumatic and inflammatory diseases: data from the French RMD COVID-19 cohort of 694 patients. Ann Rheum Dis. 2021 Apr;80(4):527-538. doi: 10.1136/annrheumdis-2020-218310. Epub 2020 Dec 2.

  PMID: 33268442 DERIVED

MeSH Terms

Conditions

Autoimmune Diseases; COVID-19

Condition Hierarchy (Ancestors)

Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eric Hachulla, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Hachulla, MD,PhD

CONTACT

320445962; covid19.fai2r@chru-lille.fr

Samira Plassart

CONTACT

samira.plassart@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 20, 2020
• Study Start: April 18, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)