Skip to main content
OpenTrials
Completed

NCT Number: NCT04353609

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sars-CoV2 Autoimmune Diseases COVID-19 Chronic Inflammatory Rheumatism Coronaviridae Infections Coronavirus Infections Immune System Diseases Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Huriez

Lille, 59037, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

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

Registry information

Official study title

Covid-19 in Patients With Chronic Inflammatory Rheumatism, Auto-immune or Auto-inflammatory Rare and Non-rare Diseases : a Retrospective Multicenter Observational Study

Acronym: covid19 fai2r

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2020
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.