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Clinical Trials/NCT04353609
NCT04353609
Unknown
Not Applicable

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

University Hospital, Lille1 site in 1 country13,770 target enrollmentApril 18, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sars-CoV2
Sponsor
University Hospital, Lille
Enrollment
13770
Locations
1
Primary Endpoint
Proportion of patients presenting a severe form of covid-19 requiring an intensive care unit admission or leading to death
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 18, 2020
End Date
December 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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