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

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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

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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
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: Eric Hachulla, MD,PhD 320445962 ext +33 covid19.fai2r@chru-lille.fr
Contact: Samira Plassart samira.plassart@chu-lyon.fr
Listed Location Countries France
Removed Location Countries  
 
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
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
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