Clinical trial NCT04353609: Covid-19 in Patients With Chronic Inflammatory Rheumatism, Auto-immune or Auto-inflammatory Rare and Non-rare Diseases
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sars-CoV2
Chronic Inflammatory Rheumatism
Autoimmune Diseases
Keywords: Covid-19
chronic inflammatory rheumatism
auto-immune diseases
auto-inflammatory diseases
intensive care unit
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
First posted: 2020-04-20
Enrollment: 13770
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients presenting a severe form of covid-19 requiring an intensive care unit admission or leading to death
timeFrame: From Baseline up to Day 21 after first symptoms of covid-19
Secondary outcomes:
measure: Proportion of patients who die from a severe form of covid-19
timeFrame: From Baseline up to Day 21 after first symptoms of covid-19
measure: Proportion of patients who present an history of diabetes according to medical records
timeFrame: Before the set-up of first symptoms of covid-19 (Baseline visit)
measure: Proportion of patients who present obesity (validated by Body Mass Index value > 30 kg/cm2)
timeFrame: At the set-up of first symptoms of covid-19 (Baseline visit)
measure: Proportion of patients who present an history of Chronic Pulmonary Obstructive Disease according to medical records
timeFrame: Before the set-up of first symptoms of covid-19 (Baseline visit)
measure: Proportion of patients who present an history of Asthma according to medical records
timeFrame: Before the set-up of first symptoms of covid-19 (Baseline visit)
measure: Proportion of patients who present an history of Hypertension according to medical records
timeFrame: Before the set-up of first symptoms of covid-19 (Baseline visit)
measure: Proportion of patients who present an history of cardiac disease according to medical records
timeFrame: Before the set-up of first symptoms of covid-19 (Baseline visit)
measure: Proportion of patients who present an history of Pulmonary Interstitial Disease according to medical records
timeFrame: Before the set-up of first symptoms of covid-19 (Baseline visit)
measure: Proportion of patients who present an history of stroke according to medical records
timeFrame: Before the set-up of first symptoms of covid-19 (Baseline visit)
measure: Proportion of patients who present an history of angiotensin-converting-enzyme inhibitor according to medical records
timeFrame: Before the set-up of first symptoms of covid-19 (Baseline visit)
measure: Proportion of patients who present an history of cancer according to medical records
timeFrame: Before the set-up of first symptoms of covid-19 (Baseline visit)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Huriez
Study officials:
affiliation: University Hospital, Lille
name: Eric Hachulla, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.