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Sars-CoV2covid19 fai2rNCT04353609

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

An observational study of Sars-CoV2 and Chronic Inflammatory Rheumatism, run by University Hospital, Lille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
How many people
13,770 participants
Where
1 siteFrance
Study dates
18 Apr 2020to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Child, Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Huriez

    Lille, 59037

Other trials in France

About this study

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

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.

Keywords
Covid-19, chronic inflammatory rheumatism, auto-immune diseases, auto-inflammatory diseases, intensive care unit
Medical subject headings
Autoimmune Diseases, COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients presenting a severe form of covid-19 requiring an intensive care unit admission or leading to death

    Measured: From Baseline up to Day 21 after first symptoms of covid-19

Secondary outcomes (11)

  1. Proportion of patients who die from a severe form of covid-19

    Measured: From Baseline up to Day 21 after first symptoms of covid-19

  2. Proportion of patients who present an history of diabetes according to medical records

    Measured: Before the set-up of first symptoms of covid-19 (Baseline visit)

  3. Proportion of patients who present obesity (validated by Body Mass Index value > 30 kg/cm2)

    Measured: At the set-up of first symptoms of covid-19 (Baseline visit)

  4. Proportion of patients who present an history of Chronic Pulmonary Obstructive Disease according to medical records

    Measured: Before the set-up of first symptoms of covid-19 (Baseline visit)

  5. Proportion of patients who present an history of Asthma according to medical records

    Measured: Before the set-up of first symptoms of covid-19 (Baseline visit)

  6. Proportion of patients who present an history of Hypertension according to medical records

    Measured: Before the set-up of first symptoms of covid-19 (Baseline visit)

  7. Proportion of patients who present an history of cardiac disease according to medical records

    Measured: Before the set-up of first symptoms of covid-19 (Baseline visit)

  8. Proportion of patients who present an history of Pulmonary Interstitial Disease according to medical records

    Measured: Before the set-up of first symptoms of covid-19 (Baseline visit)

  9. Proportion of patients who present an history of stroke according to medical records

    Measured: Before the set-up of first symptoms of covid-19 (Baseline visit)

  10. Proportion of patients who present an history of angiotensin-converting-enzyme inhibitor according to medical records

    Measured: Before the set-up of first symptoms of covid-19 (Baseline visit)

  11. Proportion of patients who present an history of cancer according to medical records

    Measured: Before the set-up of first symptoms of covid-19 (Baseline visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2020
  2. Study start18 Apr 2020
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
13,770 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04353609
Sponsor's protocol ID
NI_2020_03
Acronym
covid19 fai2r
Status last verified
May 2026
First submitted
15 Apr 2020
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37414137

  • 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.

    PubMed 36113962

  • 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.

    PubMed 33786454

  • 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.

    PubMed 33268442

Questions about this trial

What is this clinical trial studying?

An observational study of Sars-CoV2 and Chronic Inflammatory Rheumatism, run by University Hospital, Lille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04353609, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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