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

• ClinicalTrials.gov Identifier: NCT04353609
• Recruitment Status: Unknown
• First Posted: April 20, 2020
• Last Update Posted: April 22, 2020
• Sponsor: University Hospital, Lille
• Collaborator: FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
• Information provided by (Responsible Party): University Hospital, Lille

Tracking Information

• First Submitted Date: April 15, 2020
• First Posted Date: April 20, 2020
• Last Update Posted Date: April 22, 2020
• Actual Study Start Date: April 18, 2020
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 17, 2020): Proportion of patients presenting a severe form of covid-19 requiring an intensive care unit admission or leading to death [ Time Frame: From Baseline up to Day 21 after first symptoms of covid-19 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 17, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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

Condition

• Sars-CoV2
• Chronic Inflammatory Rheumatism
• Autoimmune Diseases

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 17, 2020): 13770
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04353609
• Other Study ID Numbers: NI_2020_03
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University Hospital, Lille
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Lille
• Original Study Sponsor: Same as current
• Collaborators: FAI²R (Auto-immune and auto-inflammatory rare diseases French network)

Investigators

• Principal Investigator: Eric Hachulla, MD,PhD; University Hospital, Lille

• PRS Account: University Hospital, Lille
• Verification Date: April 2020