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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04353609
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease
Sars-CoV2 Chronic Inflammatory Rheumatism Autoimmune Diseases

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Study Type : Observational
Estimated Enrollment : 13770 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : April 18, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353609


Contacts
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Contact: Eric Hachulla, MD,PhD 320445962 ext +33 covid19.fai2r@chru-lille.fr
Contact: Samira Plassart samira.plassart@chu-lyon.fr

Locations
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France
Hôpital Huriez Recruiting
Lille, France, 59037
Contact    0320445962      
Principal Investigator: Eric Hachulla, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
Investigators
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Principal Investigator: Eric Hachulla, MD,PhD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04353609    
Other Study ID Numbers: NI_2020_03
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Covid-19
chronic inflammatory rheumatism
auto-immune diseases
auto-inflammatory diseases
intensive care unit
Additional relevant MeSH terms:
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Rheumatic Fever
Rheumatic Diseases
Collagen Diseases
Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Arthritis
Joint Diseases